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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| University of Western Ontario, Canada | OTHER |
| University Health Network, Toronto | OTHER |
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The long-term goal of our research team is to conduct a large multicentre study to evaluate whether tailored home exercise can prevent fractures in high-risk individuals. The proposed project will address the feasibility of such a trial, but will also evaluate the effect of exercise on quality of life, posture and many other outcomes important to individuals with vertebral fractures. Physiotherapists will conduct 6 home visits with participants to deliver the intervention (or social visit for controls) using a similar model to previous work by our team and others. The purpose of this pilot study is determining the feasibility of recruitment, retention and adherence of an international multicentre randomized controlled study evaluating the efficacy of thrice-weekly home exercise for one year among women with vertebral fracture. As secondary objectives, the investigators will examine the effects of exercise on function, balance, quality of life, pain, falls and fractures. The primary hypothesis is that the investigators will successfully recruit and retain the target sample, and achieve an adherence rate of 60%.
There is limited data available from which to develop guidelines for safe and effective exercise prescription among individuals with hip or vertebral fractures. The long-term goal of our research team is to conduct a large multi-centre randomized controlled trial (RCT) to investigate whether participating in a thrice-weekly home exercise program for one year can reduce incident fragility fractures among women aged 65 years or older with a history of vertebral fracture compared to no intervention. The current study is a pilot study with the principal objective of determining the feasibility of recruitment, retention and adherence of an international multicentre RCT evaluating the efficacy of thrice-weekly home exercise for one year among women with vertebral fracture. The intervention was developed by experts in exercise prescription based on a rigorous literature review and Cochrane meta-analysis we have conducted. Physiotherapists will conduct 6 home visits with participants to deliver the intervention (or social visit for controls) using a similar model to previous work by our team and others. Secondary outcomes of the pilot study are those hypothesized to be among the causal pathway linking exercise to fracture risk, including lower extremity strength, posture, balance, as well as falls and fractures. Additional secondary outcomes include quality of life, pain, exercise self-efficacy, the cost of the intervention, and the risk of adverse events associated with exercise. The recruitment and retention process will be summarized using a CONSORT flow diagram, and the reporting of results will be in accordance with the CONSORT criteria. Analyses of feasibility objectives will be descriptive or based on estimates with 95% confidence intervals, where feasibility will be assessed relative to criteria defined a priori. Differences in secondary outcomes will be evaluated in intention to treat analyses via independent student T-tests, Chi Square or logistic regression. The Bonferroni method will be used to adjust the level of significance for secondary outcomes so the overall level is alpha=0.05. Even if the larger trial proves not to be feasible, the current trial will be one of the largest exercise studies among a representative group of women with vertebral fracture to date, and will evaluate the feasibility and costs of a comprehensive home exercise program, and its effect on important secondary outcomes. Osteoporosis Canada has defined a need to develop patient resources on exercise and recently announced a shift in priority to individuals with existing fractures; the proposed pilot study is timely and will directly inform these knowledge translation initiatives.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise and behaviour change strategies | Experimental | The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing. |
|
| General health or social discussion | No Intervention | Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise and behaviour change strategies | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Recruitment and Retention | Number of participants recruited and retained. Criteria for success = 20 recruited per site and at least 75% retained. | Monthly records up to 12 months. |
| Adherence | Number of exercise sessions completed relative to prescribed. We will use a diary for participants to self-report adherence. | Monthly records over 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Fractures. | Incident fracture will be a composite outcome of a vertebral fracture or fragility fracture (excluding fractures due to trauma or cancer). A fracture questionnaire will be used to ascertain the occurrence of fractures, the approximate timing and the cause with fracture occurrence, location and severity verified through health record data. Lateral thoracic and lumbar spine x-rays will be performed on participants at baseline (to confirm prevalent vertebral fractures) and follow-up (to identify new fractures). Vertebral fractures will be defined as radiographic presence of ≥25% reduction in anterior, middle or posterior height of a vertebra using the Genant visual semi-quantitative method. |
Not provided
Inclusion Criteria:
Has a) a known or suspected vertebral fracture of non-traumatic etiology OR b) one of the following:
age greater than or equal to 65 years of age
able to understand instructions in english
able to give informed consent (no cognitive impairment)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lora Giangregorio, PhD | University of Waterloo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Waterloo | Waterloo | Ontario | N2L 3G1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31899499 | Derived | Gibbs JC, McArthur C, Wark JD, Thabane L, Scherer SC, Prasad S, Papaioannou A, Mittmann N, Laprade J, Kim S, Khan A, Kendler DL, Hill KD, Cheung AM, Bleakney R, Ashe MC, Adachi JD, Giangregorio LM. The Effects of Home Exercise in Older Women With Vertebral Fractures: A Pilot Randomized Controlled Trial. Phys Ther. 2020 Apr 17;100(4):662-676. doi: 10.1093/ptj/pzz188. | |
| 24786946 |
| Label | URL |
|---|---|
| Principal Investigator | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise and Behaviour Change Strategies | The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing. Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day. |
| FG001 | General Health or Social Discussion | Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise and Behaviour Change Strategies | The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing. Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 of Recruitment and Retention | Number of participants recruited and retained. Criteria for success = 20 recruited per site and at least 75% retained. | Posted | Count of Participants | Participants | Monthly records up to 12 months. |
|
Not provided
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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 | Exercise and Behaviour Change Strategies | The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing. Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Irregular heart beat | Cardiac disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lora Giangregorio | University of Waterloo | 5198884567 | 36357 | lmgiangr@uwaterloo.ca |
Not provided
| ID | Term |
|---|---|
| D058866 | Osteoporotic Fractures |
| D016103 | Spinal Fractures |
| D010024 | Osteoporosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
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| McMaster University |
| OTHER |
| University of Melbourne | OTHER |
| University of British Columbia | OTHER |
Not provided
Not provided
Not provided
Not provided
|
| Baseline, one year and at report of fracture (monitored monthly for reports). |
| Number of Fallers | Diary for participants to self-report falls. | Monthly up to one year. |
| Occiput to Wall Distance | Baseline and one year. |
| Scores on the Short Physical Performance Battery (SPPB) | The SPPB consists of balance tests (side-by-side, semi-tandem, and tandem standing), gait speed during 4-meter walk test, and the average time taken to rise from a chair with arms folded across chest and sit back down (Five-Times-Sit-to-Stand test), sub-scores of which are added to determine a composite score (0-12), with higher scores indicative of better performance. | Baseline and one year. |
| Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER). | Balance Outcome Measure for Elder Rehabilitation (BOOMER) includes the step test, the Timed Up and Go, the Functional Reach test and the timed static stance feet together eyes closed test. The sub-scores of which are added to create a composite score (0-16), with higher scores indicating better performance. | Baseline and one year. |
| Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | OQLQ scores range 1-7, with higher scores indicate greater quality of life. EQ5D5L VAS scores range 0-100, with higher scores indicating better overall health. VAS pain scores range 0-10, with lower scores indicating less pain. | Baseline, 6 months and one year. |
| Scores on Exercise Self-efficacy Scales. | To assess self-efficacy related to engaging in exercise, participants will be asked "Over the next 3 months, how confident are you that you can perform exercise on most days of the week?" and "Over the next 3 months, how confident are you that you can perform exercise on 3 days of the week?." To assess implementation intentions, participants are asked "Do you already have concrete plans regarding exercise?". Patients will rate their answers on a scale from 1-5. Higher scores indicate greater exercise self-efficacy. | Baseline, 6 months and one year. |
| Score on Short-form Falls Efficacy Scale International (FES-I). | Questionnaire about how concerned the participant is about the possibility of falling during common daily activities. Scores range from 7 (no concern about falling) to 28 (severe concern about falling. | Baseline, 6 months and one year. |
| Productivity | Questionnaire regarding much did the participant's spine fracture(s) or osteoporosis affect their productivity while working? The scale is 0-10, with higher numbers indicating more effect on their work. | Monthly up to one year. |
| Physical Activity | A modified version of the Short-Form International Physical Activity Questionnaire (IPAQ) will be completed. A subset of participants at the University of Waterloo (St. Mary's General Hospital) will wear an accelerometer for 7 days. | Baseline, 6 months, 12 months |
| Number of Serious Adverse Events. | Defined as death or event that is life-threatening, requires hospitalization or results in disability. | Monthly up to one year. |
| Number of Individuals Screened and Eligible Per Collection Site. | Number of participants randomized out of all participants screened | over the course of the study (2.29 years) |
| Number of Potentially Eligible Males | over recruitment period |
| Number of Participants With Multiple Falls | Monthly up to 12 months. |
| Total Number of Falls | Monthly up to 12 months. |
| Value of Direct Medical Resources Per Participant. | Accrued costs over 12 months |
| Value of Non-direct Medical Resources Per Participant. | Accrued costs over 12 months |
| Participant Height | Baseline and one year |
| Activities of Daily Living | 0-10 scale about ability to do activities of daily living. Higher scores indicate more difficulty. | Monthly up to one year |
| Timed Loaded Standing Test | A physical performance measure of combined trunk and arm endurance. | Baseline and one year |
| Location of Vertebral Fractures | Any vertebral fracture (Genant Grade 1 or higher) found on x-ray, divided into location groupings of T1-T3, T4-T8, T9-L1, and L2-L5. | Baseline and Month 12 |
| Participant Weight | Baseline and Month 12 |
| Giangregorio LM, Thabane L, Adachi JD, Ashe MC, Bleakney RR, Braun EA, Cheung AM, Fraser LA, Gibbs JC, Hill KD, Hodsman AB, Kendler DL, Mittmann N, Prasad S, Scherer SC, Wark JD, Papaioannou A. Build better bones with exercise: protocol for a feasibility study of a multicenter randomized controlled trial of 12 months of home exercise in women with a vertebral fracture. Phys Ther. 2014 Sep;94(9):1337-52. doi: 10.2522/ptj.20130625. Epub 2014 May 1. |
| BG001 | General Health or Social Discussion | Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | General Health or Social Discussion | Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health. |
|
|
| Primary | Adherence | Number of exercise sessions completed relative to prescribed. We will use a diary for participants to self-report adherence. | Only the Exercise Group received the exercise program. | Posted | Mean | Full Range | % of weeks meeting adherence threshold | Monthly records over 12 months |
|
|
|
| Secondary | Number of Fractures. | Incident fracture will be a composite outcome of a vertebral fracture or fragility fracture (excluding fractures due to trauma or cancer). A fracture questionnaire will be used to ascertain the occurrence of fractures, the approximate timing and the cause with fracture occurrence, location and severity verified through health record data. Lateral thoracic and lumbar spine x-rays will be performed on participants at baseline (to confirm prevalent vertebral fractures) and follow-up (to identify new fractures). Vertebral fractures will be defined as radiographic presence of ≥25% reduction in anterior, middle or posterior height of a vertebra using the Genant visual semi-quantitative method. | Posted | Number | Fractures | Baseline, one year and at report of fracture (monitored monthly for reports). |
|
|
|
|
| Secondary | Number of Fallers | Diary for participants to self-report falls. | Posted | Count of Participants | Participants | Monthly up to one year. |
|
|
|
|
| Secondary | Occiput to Wall Distance | Posted | Mean | Standard Deviation | centimetres | Baseline and one year. |
|
|
|
|
| Secondary | Scores on the Short Physical Performance Battery (SPPB) | The SPPB consists of balance tests (side-by-side, semi-tandem, and tandem standing), gait speed during 4-meter walk test, and the average time taken to rise from a chair with arms folded across chest and sit back down (Five-Times-Sit-to-Stand test), sub-scores of which are added to determine a composite score (0-12), with higher scores indicative of better performance. | Posted | Mean | Standard Deviation | score on a scale | Baseline and one year. |
|
|
|
|
| Secondary | Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER). | Balance Outcome Measure for Elder Rehabilitation (BOOMER) includes the step test, the Timed Up and Go, the Functional Reach test and the timed static stance feet together eyes closed test. The sub-scores of which are added to create a composite score (0-16), with higher scores indicating better performance. | Posted | Mean | Standard Deviation | score on a scale | Baseline and one year. |
|
|
|
|
| Secondary | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | OQLQ scores range 1-7, with higher scores indicate greater quality of life. EQ5D5L VAS scores range 0-100, with higher scores indicating better overall health. VAS pain scores range 0-10, with lower scores indicating less pain. | Withdrawals at 6 months - intervention group (n=4) and control group (n=5). Withdrawals at 12 months - intervention group (n=5) and control group (n=6). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months and one year. |
|
|
|
|
| Secondary | Scores on Exercise Self-efficacy Scales. | To assess self-efficacy related to engaging in exercise, participants will be asked "Over the next 3 months, how confident are you that you can perform exercise on most days of the week?" and "Over the next 3 months, how confident are you that you can perform exercise on 3 days of the week?." To assess implementation intentions, participants are asked "Do you already have concrete plans regarding exercise?". Patients will rate their answers on a scale from 1-5. Higher scores indicate greater exercise self-efficacy. | Withdrawals at 6 months - intervention group (n=4) and control group (n=5). Withdrawals at 12 months - intervention group (n=5) and control group (n=6) | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months and one year. |
|
|
|
| Secondary | Score on Short-form Falls Efficacy Scale International (FES-I). | Questionnaire about how concerned the participant is about the possibility of falling during common daily activities. Scores range from 7 (no concern about falling) to 28 (severe concern about falling. | Withdrawals at 6 months - intervention group (n=4) and control group (n=5). Withdrawals at 12 months - intervention group (n=5) and control group (n=6). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months and one year. |
|
|
|
| Secondary | Productivity | Questionnaire regarding much did the participant's spine fracture(s) or osteoporosis affect their productivity while working? The scale is 0-10, with higher numbers indicating more effect on their work. | Only participants who reported working and/or volunteering were asked this question. | Posted | Mean | Standard Deviation | units on a scale | Monthly up to one year. |
|
|
|
|
| Secondary | Physical Activity | A modified version of the Short-Form International Physical Activity Questionnaire (IPAQ) will be completed. A subset of participants at the University of Waterloo (St. Mary's General Hospital) will wear an accelerometer for 7 days. | Withdrawals at 6 months - intervention group (n=4) and control group (n=5) Withdrawals at 12 months - intervention group (n=5) and control group (n=6) | Posted | Mean | Standard Deviation | Minutes per week | Baseline, 6 months, 12 months |
|
|
|
|
| Secondary | Number of Serious Adverse Events. | Defined as death or event that is life-threatening, requires hospitalization or results in disability. | Posted | Number | events | Monthly up to one year. |
|
|
|
| Secondary | Number of Individuals Screened and Eligible Per Collection Site. | Number of participants randomized out of all participants screened | Posted | Count of Participants | Participants | over the course of the study (2.29 years) |
|
|
|
| Secondary | Number of Potentially Eligible Males | Total people screened for inclusion | Posted | Count of Participants | Participants | over recruitment period |
|
|
|
| Secondary | Number of Participants With Multiple Falls | Posted | Count of Participants | Participants | Monthly up to 12 months. |
|
|
|
| Secondary | Total Number of Falls | Posted | Number | Falls | Monthly up to 12 months. |
|
|
|
|
| Secondary | Value of Direct Medical Resources Per Participant. | For each resource cost, only participants utilizing the resource are included. | Posted | Mean | Standard Deviation | Dollars (Canadian) | Accrued costs over 12 months |
|
|
|
| Secondary | Value of Non-direct Medical Resources Per Participant. | For each resource cost, only participants utilizing the resource are included. | Posted | Mean | Standard Deviation | Dollars (Canadian) | Accrued costs over 12 months |
|
|
|
| Secondary | Participant Height | Withdrawals at 12 months - intervention group (n=5) and control group (n=6). The remainder (5 intervention, 2 control) did not attend the follow-up visit. | Posted | Mean | Standard Deviation | centimetres | Baseline and one year |
|
|
|
|
| Secondary | Activities of Daily Living | 0-10 scale about ability to do activities of daily living. Higher scores indicate more difficulty. | Subsequent number of participants drops after baseline due to withdrawals or monthly follow-up not being completed. | Posted | Mean | Standard Deviation | units on a scale | Monthly up to one year |
|
|
|
|
| Secondary | Timed Loaded Standing Test | A physical performance measure of combined trunk and arm endurance. | Only participants from the University of Waterloo and the University of Toronto sites assessed. | Posted | Median | Standard Deviation | Seconds | Baseline and one year |
|
|
|
|
| Secondary | Location of Vertebral Fractures | Any vertebral fracture (Genant Grade 1 or higher) found on x-ray, divided into location groupings of T1-T3, T4-T8, T9-L1, and L2-L5. | Withdrawals at 12 months - intervention group (n=5) and control group (n=6). The remainder (9 intervention, 8 control) did not have a second x-ray. | Posted | Number | Fractures | Baseline and Month 12 |
|
|
|
| Secondary | Participant Weight | Withdrawals at 12 months - intervention group (n=5) and control group (n=6). The remainder (7 intervention, 2 control) either did not attend the follow-up visit or did not have access to a scale at the visit. | Posted | Mean | Standard Deviation | kilograms | Baseline and Month 12 |
|
|
|
|
| 0 |
| 71 |
| 17 |
| 71 |
| 43 |
| 71 |
| EG001 | General Health or Social Discussion | Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health. | 0 | 70 | 12 | 70 | 34 | 70 |
| Heart failure | Cardiac disorders |
|
| Pneumonia | Infections and infestations |
|
| Idiopathic severe left foot pain | General disorders |
|
| Fracture | Injury, poisoning and procedural complications |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders |
|
| Adverse reaction to Forteo | Product Issues |
|
| Stroke | Vascular disorders |
|
| Atrial fibrillation | Cardiac disorders |
|
| Dizziness | Cardiac disorders | pulse was really slow and blood pressured dropped. Participant had a history of heart attack. |
|
| Chest pain | Cardiac disorders |
|
| Elevated blood pressure | Cardiac disorders | palpitations and had very high blood pressure (220/110). |
|
| Severe vertigo | General disorders |
|
| Influenza | Infections and infestations |
|
| Stomach infection | Infections and infestations |
|
| Wound infection | Injury, poisoning and procedural complications |
|
| Vertebral pain | Injury, poisoning and procedural complications |
|
| Extreme knee pain | Injury, poisoning and procedural complications |
|
| Aneurysm | Vascular disorders |
|
| Hematoma | Vascular disorders |
|
| Shoulder dislocation | Musculoskeletal and connective tissue disorders |
|
| Hearing loss | Ear and labyrinth disorders |
|
| Cataracts | Eye disorders |
|
| Increased pain | General disorders |
|
| Enlarged bile duct | Hepatobiliary disorders |
|
| Rash | Immune system disorders |
|
| Bronchitis | Infections and infestations |
|
| Fracture | Injury, poisoning and procedural complications |
|
| arthritis-related pains | Musculoskeletal and connective tissue disorders |
|
| Bladder cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Vaginal tenderness | Reproductive system and breast disorders |
|
| Obstructive sleep apnea | Respiratory, thoracic and mediastinal disorders |
|
| Itchy scalp | Skin and subcutaneous tissue disorders |
|
| Skin basal cell carcinoma removed | Surgical and medical procedures |
|
| Macular degeneration | Eye disorders |
|
| Dizziness/loss of balance | General disorders |
|
| Numbness/tingling in mouth | General disorders |
|
| foot edema | General disorders |
|
| corn infected on foot | Infections and infestations |
|
| Influenza | Infections and infestations |
|
| Fungal infection | Infections and infestations |
|
| Gastroenteritis | Infections and infestations |
|
| Infected finger | Infections and infestations |
|
| Lyme Disease | Infections and infestations |
|
| Meniere's Disease | Infections and infestations |
|
| Pancreatitis | Infections and infestations |
|
| Respiratory infection | Infections and infestations |
|
| Shingles | Infections and infestations |
|
| Sinus infection | Infections and infestations |
|
| Urinary tract infection | Infections and infestations |
|
| Fall/trip | Injury, poisoning and procedural complications |
|
| Soft tissue injury | Injury, poisoning and procedural complications |
|
| Domestic violence incident | Injury, poisoning and procedural complications |
|
| Idiopathic breathing difficulties | Respiratory, thoracic and mediastinal disorders |
|
| Asthma | Respiratory, thoracic and mediastinal disorders |
|
| Gallbladder Surgery | Surgical and medical procedures |
|
| Bladder cyst surgery | Surgical and medical procedures |
|
| Glass splinter removed from finger | Surgical and medical procedures |
|
| Endoscopy | Surgical and medical procedures |
|
| Facial growth removal | Surgical and medical procedures |
|
Not provided
Not provided
| D001851 |
| Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |
Month 12
| t-test, 2 sided |
| 0.765 |
| Mean Difference (Final Values) |
| 0.14 |
| 2-Sided |
| 95 |
| -0.80 |
| 1.09 |
Per-protocol analysis |
| Superiority |
| t-test, 2 sided |
| 0.888 |
| Mean Difference (Final Values) |
| -0.05 |
| 2-Sided |
| 95 |
| -0.75 |
| 0.65 |
Per-protocol analysis |
| Superiority |
| t-test, 2 sided |
| 0.745 |
| Mean Difference (Final Values) |
| 0.11 |
| 2-Sided |
| 95 |
| -0.56 |
| 0.79 |
Per-protocol analysis |
| Superiority |
| EQ5D-VAS - Month 6 |
|
|
| EQ5D-VAS - Month 12 |
|
|
| OQLQ - Average - Baseline |
|
|
| OQLQ - Average - Month 6 |
|
|
| OQLQ - Average - Month 12 |
|
|
| Pain VAS at Rest - Baseline |
|
|
| Pain VAS at Rest - Month 6 |
|
|
| Pain VAS at Rest - Month 12 |
|
|
| Pain VAS Movement - Baseline |
|
|
| Pain VAS Movement - Month 6 |
|
|
| Pain VAS Movement - Month 12 |
|
|
| t-test, 2 sided |
| 0.585 |
| Mean Difference (Final Values) |
| 1.78 |
| 2-Sided |
| 95 |
| -4.66 |
| 8.22 |
Per-protocol analysis |
| Superiority |
| Comparison of change from baseline in OQLQ Average Score | t-test, 2 sided | 0.335 | Mean Difference (Final Values) | 0.16 | 2-Sided | 95 | -0.16 | 0.47 | Intention-to-treat analysis | Superiority |
| Comparison of change from baseline in OQLQ Average Score | t-test, 2 sided | 0.285 | Mean Difference (Final Values) | 0.18 | 2-Sided | 95 | -0.15 | 0.50 | Per-protocol analysis | Superiority |
| Comparison of change from baseline in pain VAS at rest | t-test, 2 sided | 0.225 | Mean Difference (Final Values) | -0.52 | 2-Sided | 95 | -1.36 | 0.32 | Intention-to-treat analysis | Superiority |
| Comparison of change from baseline in pain VAS at rest | t-test, 2 sided | 0.488 | Mean Difference (Final Values) | -0.30 | 2-Sided | 95 | -1.16 | 0.56 | Per-protocol analysis | Superiority |
| Comparison of change from baseline in pain VAS during movement | t-test, 2 sided | 0.808 | Mean Difference (Final Values) | 0.10 | 2-Sided | 95 | -0.68 | 0.88 | Intention-to-treat analysis | Superiority |
| Comparison of change from baseline in pain VAS during movement | t-test, 2 sided | 0.566 | Mean Difference (Final Values) | 0.23 | 2-Sided | 95 | -0.57 | 1.04 | Per-protocol analysis | Superiority |
| Month 6 |
|
|
| Month 12 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 1 |
|
|
| Month 2 |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
| Month 7 |
|
|
| Month 8 |
|
|
| Month 9 |
|
|
| Month 10 |
|
|
| Month 11 |
|
|
| Month 12 |
|
|
| 0.039 |
| Mean Difference (Final Values) |
| -1.396 |
| 2-Sided |
| 95 |
| -2.721 |
| -0.071 |
| Superiority |
| Baseline Moderate-Vigorous physical activity |
|
|
| Baseline Walking |
|
|
| Month 6 Strength/Balance physical activity |
|
|
| Month 6 Moderate-Vigorous physical activity |
|
|
| Month 6 Walking |
|
|
| Month 12 Strength/Balance physical activity |
|
|
| Month 12 Moderate-Vigorous physical activity |
|
|
| Month 12 Walking |
|
|
Only Month 6 and Month 12 strength and balance physical activity differences were significant.
| t-test, 2 sided |
| <0.05 |
Month 12 strength and balance physical activity |
| Mean Difference (Final Values) |
| -49.3 |
| 2-Sided |
| 95 |
| -69.8 |
| -28.8 |
| Superiority |
| Medical costs related to adverse events |
|
|
| Physician visits and tests/ procedures |
|
|
| Allied health professional visits |
|
|
| Lost productivity |
|
|
| Out of pocket costs |
|
|
| Month 12 |
|
|
| Month 1 |
|
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| Month 2 |
|
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| Month 3 |
|
|
| Month 4 |
|
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| Month 5 |
|
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| Month 6 |
|
|
| Month 7 |
|
|
| Month 8 |
|
|
| Month 9 |
|
|
| Month 10 |
|
|
| Month 11 |
|
|
| Month 12 |
|
|
| .60 |
| Mean Difference (Final Values) |
| 8.1 |
| Standard Error of the Mean |
| 15.3 |
| 2-Sided |
| 95 |
| -23.3 |
| 39.5 |
| Superiority |
| Baseline T4-T8 |
|
|
| Baseline T9-L1 |
|
|
| Baseline L2-L5 |
|
|
| Month 12 T1-T3 |
|
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| Month 12 T4-T8 |
|
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| Month 12 T9-L1 |
|
|
| Month 12 L2-L5 |
|
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| Month 12 |
|
|