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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| City of Lakes family Health Team | UNKNOWN |
| Schlegel-UW Research Institute for Aging | UNKNOWN |
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There is strong evidence that specific types of exercise can improve health and physical function in older adults. While community exercise classes exist, many older adults with chronic conditions may need guidance from credentialed exercise professionals to ensure sufficient dose and progression and to address fears or low exercise self-efficacy. Furthermore, low protein intake among older adults is common and initiating exercise when nutrition is inadequate may cause weight loss and limit gains in muscle strength. The primary goal is to determine the feasibility of implementing the MoveSTroNg program under real-world conditions, measured through referral and recruitment to the program and study retention and adherence rates.
The MoveStrong trial is a 1-year pilot closed cohort stepped wedge randomized control trial (RCT) to evaluate the feasibility of implementation of the MoveStrong program. This program includes a functional exercise and nutrition program that teaches older adults with chronic diseases how to perform functional resistance and balance exercises and promote adequate protein intake and nutrition. Four sites (1 Northern and 3 Southern Ontario sites) will be cluster-randomized to implement MoveStrong at one of four start times, each three weeks apart. The primary outcome will be to determine the feasibility of recruitment and referral from diverse settings (i.e., retirement homes, community centers, and family health teams) and establish the retention and adherence to the program. Secondary objectives will determine the following: What are the participant's and provider's experience with the MoveStrong program? What is the short-term responsiveness (i.e., ability to detect change) of frailty indicators (Fried Frailty Index components), protein intake, or quality of life? Who agrees to participate? What adaptations need to be made to MoveStrong, or study methods in each setting? What is the cost relative to the benefit? Is behaviour change maintained in the maintenance period? Our long term goal is to use the information from this project to develop, implement, and evaluate a sustainable, scalable and pragmatic model to deliver strength and balance training and promote adequate protein intake among older adults with chronic diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | At regular intervals (the "steps") one cluster (i.e., one site) is randomised to cross from the control to the intervention under evaluation. This process continues until all clusters have crossed over to be exposed to the intervention. At the end of the study there will be a period when all clusters are exposed. Four sites are cluster-randomized to implement MoveSTroNg at one of four start times, each three weeks apart. |
|
| Control | Other | Each cluster contributes observations under both control and intervention observation periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strength and Balance Training & Nutrition Education | Other | Exercise:A kinesiologist-led twice-weekly program. Prior to attending the program, each attendee gets a 1:1 session with the kinesiologist to decide exercise starting levels. Group exercises start with a warm-up stepping game. Participants then perform 2 sets of 8 repetitions of each exercise, gradually progressing to an intensity of 3-8 repetitions maximum. Exercises include one each of a push, pull, squat, reach/press, lunge/step-up, lift and carry movement. After, there is a 10-minute group discussion to prompt making exercise routine at home. Nutrition:Two dietitian-led interactive group seminars to promote strategies to increase protein intake and sampling of protein-rich snacks and protein supplements. Seminar topics consider the cost to prepare high protein foods, the ability of retirement home residents to alter diet, how and why to spread protein intake through the day, how much protein is in their usual choices, and easy-to-consume protein-rich snacks. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Recruitment | Definition: Number recruited at end of rollout. The criterion for success is to recruit 10 participants at each of 4 sites. | 2 month (September to October 2019) |
| Feasibility - Retention | Definition: Number retrained at post-rollout end. The criterion for success is 90% at rollout end. | Start of the program to 9 weeks |
| Feasibility - Adherence | Definition: Percentage of individuals that attended exercise and nutrition sessions. The criterion for success is 70% or higher. | 16 sessions |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | We will measure body weight with a calibrated scale. | Baseline |
| 10 Meter Walk Test | Fried Frailty Index Components: walking speed via the 10-meter walk test protocol. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chaplin Family YMCA | Cambridge | Ontario | Canada | |||
| Your Family Health Team |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25810912 | Background | Beaudart C, Rizzoli R, Bruyere O, Reginster JY, Biver E. Sarcopenia: burden and challenges for public health. Arch Public Health. 2014 Dec 18;72(1):45. doi: 10.1186/2049-3258-72-45. eCollection 2014. | |
| 25241753 | Background | Cruz-Jentoft AJ, Landi F, Schneider SM, Zuniga C, Arai H, Boirie Y, Chen LK, Fielding RA, Martin FC, Michel JP, Sieber C, Stout JR, Studenski SA, Vellas B, Woo J, Zamboni M, Cederholm T. Prevalence of and interventions for sarcopenia in ageing adults: a systematic review. Report of the International Sarcopenia Initiative (EWGSOP and IWGS). Age Ageing. 2014 Nov;43(6):748-59. doi: 10.1093/ageing/afu115. Epub 2014 Sep 21. |
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If requested we will consider sharing data. If raw data is shared, participant data will be deidentified.
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Within one-week of randomization but prior to the start of the intervention, five individuals dropped out.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arbour Trails | At regular intervals (the "steps") one cluster (i.e., one site) is randomised to cross from the control to the intervention under evaluation. This process continues until all clusters have crossed over to be exposed to the intervention. At the end of the study there will be a period when all clusters are exposed. Four sites are cluster-randomized to implement MoveSTroNg at one of four start times, each three weeks apart. Strength and Balance Training & Nutrition Education: Exercise:A kinesiologist-led twice-weekly program. Prior to attending the program, each attendee gets a 1:1 session with the kinesiologist to decide exercise starting levels. Group exercises start with a warm-up stepping game. Participants then perform 2 sets of 8 repetitions of each exercise, gradually progressing to an intensity of 3-8 repetitions maximum. Exercises include one each of a push, pull, squat, reach/press, lunge/step-up, lift and carry movement. After, there is a 10-minute group discussion to prompt making exercise routine at home. Nutrition:Two dietitian-led interactive group seminars to promote strategies to increase protein intake and sampling of protein-rich snacks and protein supplements. Seminar topics consider the cost to prepare high protein foods, the ability of retirement home residents to alter diet, how and why to spread protein intake through the day, how much protein is in their usual choices, and easy-to-consume protein-rich snacks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 18, 2019 |
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| YMCA |
| OTHER |
We will use a closed cohort stepped wedge design at 4 sites (1 in Northern Ontario and 3 in Southern Ontario). In a stepped wedge, sites are cluster-randomized to implement MoveSTroNg at one of four start times, each three weeks apart.
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Single (Outcomes Assessor)
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|
| Usual Care | Other | During periods when a site is not involved in the MoveSTroNg program, participants will continue with their usual care routine. Usual care routines should not involve strength and balance exercises. |
|
| Mean change from follow up (study visit 4) and baseline |
| Grip Strength | Fried Frailty Index Components: weakness via the Jamar hand-held dynamometer | Mean change from follow up (study visit 4) and baseline |
| 30 Second Chair Stand Test | We will use a chair with a straight back without arm rests (seat 17" high), and a stopwatch. This will assess leg strength and endurance. | Mean change from follow up (study visit 4) and baseline |
| 4 Square Step Test | The Four Square Step Test is used to assess dynamic stability and the ability of the subject to step over low objects forward, sideways, and backward. For older adults > 15 seconds indicates increased risk of falls | Mean change from follow up (study visit 4) and baseline |
| EuroQol 5 Dimension Version 5-level (EQ-5D-5L) | The EuroQol 5 dimension version 5-level (EQ-5D-5L) measures quality of life using 5 dimensions, on a 5 point scale, where a higher point is considered better. The scores on the subscales are given weights and summed to convert the scores to one index score. The range of possible scores for the EQ-5D-5L index is from -0.573 to 1. A higher score is better. | Mean change from follow up (study visit 4) and baseline |
| Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool | We will use the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool to conduct interviewer administered diet recalls for 2 weekdays and 1 weekend day. Nutrient analysis is automated and will be used to quantify and compare protein and energy intakes at baseline and follow-up only. There is no scale to this section | Mean change from follow up (study visit 4) and baseline |
| Number of Participants With Adverse Events | We will ask participants to report adverse events and falls, using Health Canada definitions. We will report serious and non-serious adverse events (total and attributable to intervention). There is no scale to this section | Study visit 1, 2, 3 and 4 |
| Participant and Provider Experience | We used a semi-structured interview guide to conduct exit interviews with each participant and kinesiologist. Interviews and training sessions will be audio-recorded and transcribed verbatim. Two researchers will perform thematic analyses to describe participant and provider experience and satisfaction, adaptations, and learning needs. There is no scale to this section. | study visit 4 |
| Greater Sudbury |
| Ontario |
| P3A 2T4 |
| Canada |
| The Village of Arbour Trails | Guelph | Ontario | N1G 0C9 | Canada |
| Village of Winston Park | Kitchener | Ontario | N2E 3K1 | Canada |
| A.R. Kaufman Family YMCA | Kitchener | Ontario | N2G 3C5 | Canada |
| 27707740 | Background | Sherrington C, Michaleff ZA, Fairhall N, Paul SS, Tiedemann A, Whitney J, Cumming RG, Herbert RD, Close JCT, Lord SR. Exercise to prevent falls in older adults: an updated systematic review and meta-analysis. Br J Sports Med. 2017 Dec;51(24):1750-1758. doi: 10.1136/bjsports-2016-096547. Epub 2016 Oct 4. |
| 11253156 | Background | Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146. |
| 24866862 | Background | Pahor M, Guralnik JM, Ambrosius WT, Blair S, Bonds DE, Church TS, Espeland MA, Fielding RA, Gill TM, Groessl EJ, King AC, Kritchevsky SB, Manini TM, McDermott MM, Miller ME, Newman AB, Rejeski WJ, Sink KM, Williamson JD; LIFE study investigators. Effect of structured physical activity on prevention of major mobility disability in older adults: the LIFE study randomized clinical trial. JAMA. 2014 Jun 18;311(23):2387-96. doi: 10.1001/jama.2014.5616. |
| 23036876 | Background | Brosseau L, Wells GA, Poitras S, Tugwell P, Casimiro L, Novikov M, Loew L, Sredic D, Clement S, Gravelle A, Kresic D, Hua K, Lakic A, Menard G, Sabourin S, Bolduc MA, Ratte I, McEwan J, Furlan AD, Gross A, Dagenais S, Dryden T, Muckenheim R, Cote R, Pare V, Rouhani A, Leonard G, Finestone HM, Laferriere L, Haines-Wangda A, Russell-Doreleyers M, De Angelis G, Cohoon C. Ottawa Panel evidence-based clinical practice guidelines on therapeutic massage for low back pain. J Bodyw Mov Ther. 2012 Oct;16(4):424-55. doi: 10.1016/j.jbmt.2012.04.002. Epub 2012 Jun 23. |
| 24281053 | Background | Giangregorio LM, Papaioannou A, Macintyre NJ, Ashe MC, Heinonen A, Shipp K, Wark J, McGill S, Keller H, Jain R, Laprade J, Cheung AM. Too Fit To Fracture: exercise recommendations for individuals with osteoporosis or osteoporotic vertebral fracture. Osteoporos Int. 2014 Mar;25(3):821-35. doi: 10.1007/s00198-013-2523-2. Epub 2013 Nov 27. |
| 27486153 | Background | Ravindran AV, Balneaves LG, Faulkner G, Ortiz A, McIntosh D, Morehouse RL, Ravindran L, Yatham LN, Kennedy SH, Lam RW, MacQueen GM, Milev RV, Parikh SV; CANMAT Depression Work Group. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder: Section 5. Complementary and Alternative Medicine Treatments. Can J Psychiatry. 2016 Sep;61(9):576-87. doi: 10.1177/0706743716660290. Epub 2016 Aug 2. |
| 10474547 | Background | Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322. |
| 20543750 | Background | Peterson MD, Sen A, Gordon PM. Influence of resistance exercise on lean body mass in aging adults: a meta-analysis. Med Sci Sports Exerc. 2011 Feb;43(2):249-58. doi: 10.1249/MSS.0b013e3181eb6265. |
| 26420238 | Background | Borde R, Hortobagyi T, Granacher U. Dose-Response Relationships of Resistance Training in Healthy Old Adults: A Systematic Review and Meta-Analysis. Sports Med. 2015 Dec;45(12):1693-720. doi: 10.1007/s40279-015-0385-9. |
| 19588334 | Background | Liu CJ, Latham NK. Progressive resistance strength training for improving physical function in older adults. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD002759. doi: 10.1002/14651858.CD002759.pub2. |
| 29310138 | Background | Trombetti A, Hars M, Hsu FC, Reid KF, Church TS, Gill TM, King AC, Liu CK, Manini TM, McDermott MM, Newman AB, Rejeski WJ, Guralnik JM, Pahor M, Fielding RA; LIFE Study Investigators. Effect of Physical Activity on Frailty: Secondary Analysis of a Randomized Controlled Trial. Ann Intern Med. 2018 Mar 6;168(5):309-316. doi: 10.7326/M16-2011. Epub 2018 Jan 9. |
| 36108334 | Background | Wang E, Keller H, Mourtzakis M, Rodrigues IB, Steinke A, Ashe MC, Thabane L, Brien S, Funnell L, Cheung AM, Milligan J, Papaioannou A, Weston ZJ, Straus S, Giangregorio L. MoveStrong at home: a feasibility study of a model for remote delivery of functional strength and balance training combined with nutrition education for older pre-frail and frail adults. Appl Physiol Nutr Metab. 2022 Dec 1;47(12):1172-1186. doi: 10.1139/apnm-2022-0195. Epub 2022 Sep 15. |
| 35766913 | Result | Rodrigues IB, Wagler JB, Keller H, Thabane L, Weston ZJ, Straus SE, Papaioannou A, Mourtzakis M, Milligan J, Isaranuwatchai W, Loong D, Jain R, Funnell L, Cheung AM, Brien S, Ashe MC, Giangregorio LM. Encouraging older adults with pre-frailty and frailty to "MoveStrong": an analysis of secondary outcomes for a pilot randomized controlled trial. Health Promot Chronic Dis Prev Can. 2022 Jun;42(6):238-251. doi: 10.24095/hpcdp.42.6.02. |
| 34559837 | Result | Rodrigues IB, Wang E, Keller H, Thabane L, Ashe MC, Brien S, Cheung AM, Funnell L, Jain R, Loong D, Isaranuwatchai W, Milligan J, Mourtzakis M, Papaioannou A, Straus S, Weston ZJ, Giangregorio LM. The MoveStrong program for promoting balance and functional strength training and adequate protein intake in pre-frail older adults: A pilot randomized controlled trial. PLoS One. 2021 Sep 24;16(9):e0257742. doi: 10.1371/journal.pone.0257742. eCollection 2021. |
| FG001 | Kinnect to Wellness | At regular intervals (the "steps") one cluster (i.e., one site) is randomised to cross from the control to the intervention under evaluation. This process continues until all clusters have crossed over to be exposed to the intervention. At the end of the study there will be a period when all clusters are exposed. Four sites are cluster-randomized to implement MoveSTroNg at one of four start times, each three weeks apart. Strength and Balance Training & Nutrition Education: Exercise:A kinesiologist-led twice-weekly program. Prior to attending the program, each attendee gets a 1:1 session with the kinesiologist to decide exercise starting levels. Group exercises start with a warm-up stepping game. Participants then perform 2 sets of 8 repetitions of each exercise, gradually progressing to an intensity of 3-8 repetitions maximum. Exercises include one each of a push, pull, squat, reach/press, lunge/step-up, lift and carry movement. After, there is a 10-minute group discussion to prompt making exercise routine at home. Nutrition:Two dietitian-led interactive group seminars to promote strategies to increase protein intake and sampling of protein-rich snacks and protein supplements. Seminar topics consider the cost to prepare high protein foods, the ability of retirement home residents to alter diet, how and why to spread protein intake through the day, how much protein is in their usual choices, and easy-to-consume protein-rich snacks. |
| FG002 | Winston Park | At regular intervals (the "steps") one cluster (i.e., one site) is randomised to cross from the control to the intervention under evaluation. This process continues until all clusters have crossed over to be exposed to the intervention. At the end of the study there will be a period when all clusters are exposed. Four sites are cluster-randomized to implement MoveSTroNg at one of four start times, each three weeks apart. Strength and Balance Training & Nutrition Education: Exercise:A kinesiologist-led twice-weekly program. Prior to attending the program, each attendee gets a 1:1 session with the kinesiologist to decide exercise starting levels. Group exercises start with a warm-up stepping game. Participants then perform 2 sets of 8 repetitions of each exercise, gradually progressing to an intensity of 3-8 repetitions maximum. Exercises include one each of a push, pull, squat, reach/press, lunge/step-up, lift and carry movement. After, there is a 10-minute group discussion to prompt making exercise routine at home. Nutrition:Two dietitian-led interactive group seminars to promote strategies to increase protein intake and sampling of protein-rich snacks and protein supplements. Seminar topics consider the cost to prepare high protein foods, the ability of retirement home residents to alter diet, how and why to spread protein intake through the day, how much protein is in their usual choices, and easy-to-consume protein-rich snacks. |
| FG003 | YMCAs | At regular intervals (the "steps") one cluster (i.e., one site) is randomised to cross from the control to the intervention under evaluation. This process continues until all clusters have crossed over to be exposed to the intervention. At the end of the study there will be a period when all clusters are exposed. Four sites are cluster-randomized to implement MoveSTroNg at one of four start times, each three weeks apart. Strength and Balance Training & Nutrition Education: Exercise:A kinesiologist-led twice-weekly program. Prior to attending the program, each attendee gets a 1:1 session with the kinesiologist to decide exercise starting levels. Group exercises start with a warm-up stepping game. Participants then perform 2 sets of 8 repetitions of each exercise, gradually progressing to an intensity of 3-8 repetitions maximum. Exercises include one each of a push, pull, squat, reach/press, lunge/step-up, lift and carry movement. After, there is a 10-minute group discussion to prompt making exercise routine at home. Nutrition:Two dietitian-led interactive group seminars to promote strategies to increase protein intake and sampling of protein-rich snacks and protein supplements. Seminar topics consider the cost to prepare high protein foods, the ability of retirement home residents to alter diet, how and why to spread protein intake through the day, how much protein is in their usual choices, and easy-to-consume protein-rich snacks. |
| COMPLETED |
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| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | At regular intervals (the "steps") one cluster (i.e., one site) is randomised to cross from the control to the intervention under evaluation. This process continues until all clusters have crossed over to be exposed to the intervention. At the end of the study there will be a period when all clusters are exposed. Four sites are cluster-randomized to implement MoveSTroNg at one of four start times, each three weeks apart. Strength and Balance Training & Nutrition Education: Exercise:A kinesiologist-led twice-weekly program. Prior to attending the program, each attendee gets a 1:1 session with the kinesiologist to decide exercise starting levels. Group exercises start with a warm-up stepping game. Participants then perform 2 sets of 8 repetitions of each exercise, gradually progressing to an intensity of 3-8 repetitions maximum. Exercises include one each of a push, pull, squat, reach/press, lunge/step-up, lift and carry movement. After, there is a 10-minute group discussion to prompt making exercise routine at home. Nutrition:Two dietitian-led interactive group seminars to promote strategies to increase protein intake and sampling of protein-rich snacks and protein supplements. Seminar topics consider the cost to prepare high protein foods, the ability of retirement home residents to alter diet, how and why to spread protein intake through the day, how much protein is in their usual choices, and easy-to-consume protein-rich snacks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | We had 44 participants total across four sites. | Count of Participants | Participants |
| |||||||||||||||||
| Age, Continuous | Measure Analysis Population Description: We had different numbers of participants at each site, and 44 participants total across four sites. | Mean | Full Range | years |
| ||||||||||||||||
| Sex: Female, Male | We had 44 participants total across four sites. | Count of Participants | Participants |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | We had 44 participants total across four sites. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility - Recruitment | Definition: Number recruited at end of rollout. The criterion for success is to recruit 10 participants at each of 4 sites. | Five individuals withdrew a few days after randomization, and, since the program had not started, we recruited an additional four participants. | Posted | Number | # of participants @ start of study | 2 month (September to October 2019) |
|
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| Primary | Feasibility - Retention | Definition: Number retrained at post-rollout end. The criterion for success is 90% at rollout end. | Posted | Number | # of participants that completed study | Start of the program to 9 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Feasibility - Adherence | Definition: Percentage of individuals that attended exercise and nutrition sessions. The criterion for success is 70% or higher. | Posted | Mean | Full Range | % of exercise sessions completed | 16 sessions |
|
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| Secondary | Body Weight | We will measure body weight with a calibrated scale. | We used a standard scale to weight each participant in Kg | Posted | Mean | Standard Deviation | Baseline body weight in Kg | Baseline |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 10 Meter Walk Test | Fried Frailty Index Components: walking speed via the 10-meter walk test protocol. | 10-meter walk test protocol. (m/s) | Posted | Mean | Standard Deviation | Change in gait speed (meters/second) | Mean change from follow up (study visit 4) and baseline |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Grip Strength | Fried Frailty Index Components: weakness via the Jamar hand-held dynamometer | Grip strength in Kg | Posted | Mean | Standard Deviation | Change in Grip Strength (Kg) | Mean change from follow up (study visit 4) and baseline |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 30 Second Chair Stand Test | We will use a chair with a straight back without arm rests (seat 17" high), and a stopwatch. This will assess leg strength and endurance. | Number of chair stands within 30 seconds | Posted | Mean | Standard Deviation | Change number of sit to stands | Mean change from follow up (study visit 4) and baseline |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 4 Square Step Test | The Four Square Step Test is used to assess dynamic stability and the ability of the subject to step over low objects forward, sideways, and backward. For older adults > 15 seconds indicates increased risk of falls | The Four Square Step Test is used to assess dynamic stability and the ability of the subject to step over low objects forward, sideways, and backward. For older adults > 15 seconds indicates increased risk of falls | Posted | Mean | Standard Deviation | seconds | Mean change from follow up (study visit 4) and baseline |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | EuroQol 5 Dimension Version 5-level (EQ-5D-5L) | The EuroQol 5 dimension version 5-level (EQ-5D-5L) measures quality of life using 5 dimensions, on a 5 point scale, where a higher point is considered better. The scores on the subscales are given weights and summed to convert the scores to one index score. The range of possible scores for the EQ-5D-5L index is from -0.573 to 1. A higher score is better. | Higher score is better | Posted | Mean | Standard Deviation | change in score on a scale | Mean change from follow up (study visit 4) and baseline |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool | We will use the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool to conduct interviewer administered diet recalls for 2 weekdays and 1 weekend day. Nutrient analysis is automated and will be used to quantify and compare protein and energy intakes at baseline and follow-up only. There is no scale to this section | For protein intake at baseline, we only collected baseline measures for 40 individuals. Specific site data is not available | Posted | Mean | 95% Confidence Interval | protein in grams/day | Mean change from follow up (study visit 4) and baseline |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | We will ask participants to report adverse events and falls, using Health Canada definitions. We will report serious and non-serious adverse events (total and attributable to intervention). There is no scale to this section | Posted | Number | participants | Study visit 1, 2, 3 and 4 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Participant and Provider Experience | We used a semi-structured interview guide to conduct exit interviews with each participant and kinesiologist. Interviews and training sessions will be audio-recorded and transcribed verbatim. Two researchers will perform thematic analyses to describe participant and provider experience and satisfaction, adaptations, and learning needs. There is no scale to this section. | Not Posted | study visit 4 | Participants |
Over 6 months
Adverse events are unfavourable or unintended occurrence in the health or well-being of a research participant; these events may or may not be related to the intervention. We reported two types of adverse events: 1) serious adverse events defined by Health Canada as "events that result in death, hospitalization, or disability", or 2) minor adverse events. We classified each adverse event as either "not related", "related", or "possibly related" to the intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | There were two minor adverse events possibly related to the intervention and one serious adverse event related to the intervention. One participant reported groin strain while exercising but was subsequently diagnosed with hip osteoarthritis. After one-week of rest, this individual returned with a modified exercise program. The second participant had a history of right Achilles tendinitis and complained of ankle pain during the "heel drop" (i.e., impact) movement. Although all lower body exercises were ceased, after one week they withdrew from the study. One participant sustained an inferior pubic ramus fracture after a fall during the "stepping-up" movement; although this participant did not withdraw from the study, we terminated all exercises with this individual. | 0 | 0 | 1 | 44 | 0 | 44 |
| EG001 | Control | There were three minor and two serious adverse events not related to the intervention. One participant slipped in the living room and fractured the metatarsal bones of their left foot. Another participant fell while attempting to sit on an unlocked walker and sustained a right inferior and superior pubic ramus fracture; this participant withdrew from the study. Two participants reported to the emergency room: one with high blood pressure and the other after experiencing a transient ischemic attack. The last participant was at home when they experienced a seizure due to unknown causes and was admitted to the hospital for observation. The participants that experienced the pubic ramus fractures and the seizure were categorized as serious adverse events as a result of being hospitalized. | 0 | 0 | 2 | 44 | 3 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intervention | Musculoskeletal and connective tissue disorders | Systematic Assessment | One participant slipped in the living room and fractured the metatarsal bones. Another fell while sitting on an unlocked walker and sustained a right inferior and superior pubic ramus fracture. One sustained an inferior pubic ramus fracture. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardio | Cardiac disorders | Systematic Assessment | high blood pressure |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| The MoveStrong program for promoting balance and functional strength training and adequate protein i | University of Waterloo | 519-888-4567 | 46357 | lmgiangr@uwaterloo.ca |
| Jul 22, 2019 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D003920 | Diabetes Mellitus |
| D009369 | Neoplasms |
| D002318 | Cardiovascular Diseases |
| D006333 | Heart Failure |
| D006973 | Hypertension |
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001168 | Arthritis |
| D020521 | Stroke |
| D007674 | Kidney Diseases |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided
| >=65 years |
|
| Kinnect to Wellness (n = 15) |
|
|
| Village of Winston Park (n = 9) |
|
|
| YMCA (n = 11) |
|
|
| Kinnect to Wellness |
|
|
| Village of Winston Park |
|
|
| YMCA |
|
|
| Male |
|
| Kinnect to Wellness |
|
|
| Village of Winston Park |
|
|
| YMCA |
|
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Kinnect to Wellness |
|
|
| Village of Winston Park |
|
|
| YMCA |
|
|
| OG002 | Village of Winston Park | Retirement/assisted living home and independent living, Kitchener, site 3 Strength and Balance Training & Nutrition Education: Exercise:A kinesiologist-led twice-weekly program. Prior to attending the program, each attendee gets a 1:1 session with the kinesiologist to decide exercise starting levels. Group exercises start with a warm-up stepping game. Participants then perform 2 sets of 8 repetitions of each exercise, gradually progressing to an intensity of 3-8 repetitions maximum. Exercises include one each of a push, pull, squat, reach/press, lunge/step-up, lift and carry movement. After, there is a 10-minute group discussion to prompt making exercise routine at home. Nutrition:Two dietitian-led interactive group seminars to promote strategies to increase protein intake and sampling of protein-rich snacks and protein supplements. Seminar topics consider the cost to prepare high protein foods, the ability of retirement home residents to alter diet, how and why to spread protein intake through the day, how much protein is in their usual choices, and easy-to-consume protein-rich snacks. |
| OG003 | YMCA's | YMCA's of Cambridge and Kitchener-Waterloo, site 4 Strength and Balance Training & Nutrition Education: Exercise:A kinesiologist-led twice-weekly program. Prior to attending the program, each attendee gets a 1:1 session with the kinesiologist to decide exercise starting levels. Group exercises start with a warm-up stepping game. Participants then perform 2 sets of 8 repetitions of each exercise, gradually progressing to an intensity of 3-8 repetitions maximum. Exercises include one each of a push, pull, squat, reach/press, lunge/step-up, lift and carry movement. After, there is a 10-minute group discussion to prompt making exercise routine at home. Nutrition:Two dietitian-led interactive group seminars to promote strategies to increase protein intake and sampling of protein-rich snacks and protein supplements. Seminar topics consider the cost to prepare high protein foods, the ability of retirement home residents to alter diet, how and why to spread protein intake through the day, how much protein is in their usual choices, and easy-to-consume protein-rich snacks. |
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