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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG029285-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this pilot study is to develop and conduct well-designed trial to assess whether a multi-factorial intervention involving physical activity and cognitive training reduces the risk of significant cognitive decline in older individuals.
Evidence from small or uncontrolled studies indicates that physical exercise and cognitive training have considerable promise as prevention strategies, to the extent that they are often recommended; however, their efficacy has not been established by an adequately powered randomized clinical trial.
This pilot study will provide the experience and data to assess whether physical activity and cognitive training separately improve cognitive function over 6 months. It will also determine whether a combination intervention holds promise beyond individual interventions without compromising adherence, and will provide information necessary to design a well-organized and efficient full scale, multi-center randomized clinical trial.
The Physical Activity Training (PAT) will consist of center-based and home-based sessions to include aerobic, strength, flexibility, and balance training. The actual time spent exercising will vary from person to person and will also vary depending on what stage of the study they are in.
The Cognitive Training (CT) intervention was developed to improve consciously-controlled memory processing or recollection of episodic memory information and produces changes in performance that transfer to executive function, such as working memory, planning and memory monitoring, as well as long term item memory and cognitive processing speed.
The Healthy Aging Education (HAE) control will combine health education-based lectures with light stretching and toning. HAE will include an experiential component, in which participants will learn how to take charge of their health and seek out appropriate medical services and information. Topics such as medications, foot care, traveling and nutrition will be covered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Activity Training | Experimental | The Physical Activity Training ((PAT) intervention consisted of center-based and home-based sessions comprised of aerobic, strength, flexibility, and balance training with a targeted duration of 150 mins/wk. |
|
| Cognitive Training | Experimental | The Cognitive Training (CT) intervention was developed to improve consciously-controlled memory processing or recollection of episodic memory information. |
|
| Combined Intervention | Experimental | The Combined Intervention (PACT) was designed so that participants received both cognitive and physical activity training on the same day. . |
|
| Healthy Aging Education | Active Comparator | The Healthy Aging Education control intervention consisted of weekly lectures based on health education. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Activity Training | Behavioral | Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Cognitive Function in Z-scores (i.e. Which Converts Raw Data to Standard Deviation (SD) Units: [Score-mean]/SD]). This Composite is Formed by Averaging the Z-scores From Individual Tests. | 6 measures of executive functioning: Self-Ordered Pointing task (24): working memory 1- and 2-Back tests (25-26): working memory Eriksen flanker (27): response inhibition Task Switching (28): attentional flexibility Trail Making (29): executive function z-score=(raw score-mean)/standard deviation 4 measures of episodic memory Hopkins Verbal Learning Test (30) Wechsler Memory Scale-III (31) A composite of 10 scores: dividing each's difference from the baseline mean by the baseline SD, averaging the 6 executive function and 4 episodic memory z-transformed measures, and norming to have SD 1. 24. Petrides. Neuropsych 1982;20:249-62. 25. Dobbs. Psychol Aging 1989;4:500-3. 26. Jonides. J Cog Neurosci 1997;9:462-75. 27. Ericksen. Br J Sports Med 2009;43:22-4. 28. Kramer. Acta Psychologica 1999;101:339-78. 29. Reitan. Per Motor Skills 1958;8:271-6. 30. Brandt. Clin Neuropsych 1991;5:125-42. 31. Wechsler D.1997. Psychological Corporation, Harcourt, Inc: San Antonio. | Changes from baseline at 4 months in z-scores. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Executive Function: Z-score Formed by Averaging the Individual Z-scores From the Five Tests Listed Below. | Composite of 5 tasks: Self-Ordered Pointing Task of planning, working memory, and monitoring. Subjects view 16 abstract shapes and choose a shape so that each is selected by the 16th trial and none is chosen more than once. (Eriksen, Percept Psychophysiology 1974;16:143-49). N-Back Test of working memory. Subjects see individual letters and indicate whether the letter is the same as the nth back letter, with n equal to 1 and 2. (Dobbs, Psychol Aging 1989;4:500-3.) Eriksen flanker task of response incompatibility. Subjects see an arrow facing either right or left and indicate the direction.The target displays can be neutral congruent, or incongruent. (Eriksen, Percept Psychophys 1974;16:143-49.) Trail Making Test-Part B of alternating attention. Subjects connect 25 labeled circles and are scored by completion time. The lower the scores the better the performance. See details in the primary outcome. Raw scores for each test were converted to z-scores. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Espeland, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12661673 | Background | Colcombe S, Kramer AF. Fitness effects on the cognitive function of older adults: a meta-analytic study. Psychol Sci. 2003 Mar;14(2):125-30. doi: 10.1111/1467-9280.t01-1-01430. | |
| 16773952 | Background | Espeland MA, Rapp SR, Robertson J, Granek I, Murphy C, Albert M, Bassford T; Women's Health Initiative Memory Study. Benchmarks for designing two-stage studies using modified mini-mental state examinations: experience from the Women's Health Initiative Memory Study. Clin Trials. 2006;3(2):99-106. doi: 10.1191/1740774506cn140oa. |
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Available on request and development of a data sharing agreement.
On request
Data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Physical Activity Training | The Physical Activity Training ((PAT) intervention consisted of center-based and home-based sessions comprised of aerobic, strength, flexibility, and balance training with a targeted duration of 150 minutes/week. It included two center and two home-based training sessions per week for four months. Its primary focus was walking with the explicit intent of improving cardiovascular fitness. Other forms of endurance activity (e.g., stationary cycling) were used when regular walking was contraindicated for medical or behavioral reasons. Center-based physical activity sessions were supplemented with additional tailored home-based walking sessions at 1-2 per week during the first month. Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions. |
| FG001 | Cognitive Training | The Cognitive Training (CT) intervention was developed to improve consciously-controlled memory processing or recollection of episodic memory information. Sessions were center-based, conducted via computer, carried out with small groups, and monitored by skilled trainers. Training consisted of four consecutive 10-12 min sessions per day, administered two times per week for two months, which then tapered to one time per week for two additional months. For each session, participants studied a list of 30 words, followed by a recognition test consisting of the 30 studied words and 30 new words with each new word repeated once, and asked to respond "yes" to study words and "no" to the new items both times they occurred. Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6. |
| FG002 | Combined Intervention | The Combined Intervention (PACT) was designed so that participants received both cognitive and physical activity training on the same day. To avoid the potential impact of physical fatigue on cognitive training, the cognitive treatment was delivered prior to the physical activity treatment. It included both the PA and CT interventions. Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions. Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6. |
| FG003 | Healthy Aging | The Healthy Aging Education control intervention consisted of weekly lectures based on health education and was based on a program developed by the Lifestyle Interventions and Independence for Elders pilot trial [Rejeski, 2005; Lifestyle Interventions and Independence for Elders, 2006]. Topics such as medications, foot care, traveling and nutrition were covered. The purpose of the intervention was to provide contact time with participants. Healthy Aging Education (HAE): One 1-hour lecture each week for 3 months, then monthly. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Physical Activity Training | The Physical Activity Training ((PAT) intervention consisted of center-based and home-based sessions comprised of aerobic, strength, flexibility, and balance training with a targeted duration of 150 minutes/week. It included two center and two home-based training sessions per week for four months. Its primary focus was walking with the explicit intent of improving cardiovascular fitness. Other forms of endurance activity (e.g., stationary cycling) were used when regular walking was contraindicated for medical or behavioral reasons. Center-based physical activity sessions were supplemented with additional tailored home-based walking sessions at 1-2 per week during the first month. Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions. |
| 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 | Composite Cognitive Function in Z-scores (i.e. Which Converts Raw Data to Standard Deviation (SD) Units: [Score-mean]/SD]). This Composite is Formed by Averaging the Z-scores From Individual Tests. | 6 measures of executive functioning: Self-Ordered Pointing task (24): working memory 1- and 2-Back tests (25-26): working memory Eriksen flanker (27): response inhibition Task Switching (28): attentional flexibility Trail Making (29): executive function z-score=(raw score-mean)/standard deviation 4 measures of episodic memory Hopkins Verbal Learning Test (30) Wechsler Memory Scale-III (31) A composite of 10 scores: dividing each's difference from the baseline mean by the baseline SD, averaging the 6 executive function and 4 episodic memory z-transformed measures, and norming to have SD 1. 24. Petrides. Neuropsych 1982;20:249-62. 25. Dobbs. Psychol Aging 1989;4:500-3. 26. Jonides. J Cog Neurosci 1997;9:462-75. 27. Ericksen. Br J Sports Med 2009;43:22-4. 28. Kramer. Acta Psychologica 1999;101:339-78. 29. Reitan. Per Motor Skills 1958;8:271-6. 30. Brandt. Clin Neuropsych 1991;5:125-42. 31. Wechsler D.1997. Psychological Corporation, Harcourt, Inc: San Antonio. | Participants assessed at four months post-randomization. Note that this does not include all who were randomized due to dropout. | Posted | Mean | Standard Error | z-scores (e.g.Standard Deviation Units) | Changes from baseline at 4 months in z-scores. |
4 months. Note that all randomized participants are included in the adverse events accounting. Only a subset are included in the analyses of outcomes - -these by protocol were limited to those providing outcome data.
Clinicaltrials.gov definition was used.
A Data Safety Monitoring Board (DSMB) monitored all aspects of the study, including those that require access to blinded data. Included in each DSMB report was a summary of any safety issues that may have arisen since the last DSMB meeting, prepared by the Safety Officer. Any serious adverse event that might be due to the study intervention was to be reported immediately to the DSMB, the Institutional Review Board (IRB) and the Project Office.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Physical Activity Training | The Physical Activity Training ((PAT) intervention consisted of center-based and home-based sessions comprised of aerobic, strength, flexibility, and balance training with a targeted duration of 150 minutes/week. It included two center and two home-based training sessions per week for four months. Its primary focus was walking with the explicit intent of improving cardiovascular fitness. Other forms of endurance activity (e.g., stationary cycling) were used when regular walking was contraindicated for medical or behavioral reasons. Center-based physical activity sessions were supplemented with additional tailored home-based walking sessions at 1-2 per week during the first month. Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Vascular disorders | Standard | Systematic Assessment | The stoke occurred after randomization but prior to any intervention delivery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-serious | Musculoskeletal and connective tissue disorders | standard | Systematic Assessment | There have been 22 Adverse Events reported, e.g. knee/hip/shin pain, back pain, nose bleeds, high blood pressure, shortness of breath, headaches, falls, diverticulitis, ankle and toe injuries, etc. Records no longer exist for greater specificity. |
While large enough to meet its objectives, our pilot trial involved a modest sample size and short follow-up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Espeland, PhD | Wake Forest School of Medicine | 336-761-2826 | 336 | mespelan@wakehealth.edu |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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Participants were randomly assigned, with equal probability to one of four conditions: an educational control condition, moderate-intensity physical activity training, repetition lag cognitive training, or both physical activity and repetitive lag training.
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Data collection related to study outcomes was performed by staff who were masked to intervention assignment.
|
| Cognitive Training | Behavioral | Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6. |
|
| Healthy Aging Education | Behavioral | One 1-hour lecture each week for 3 months, then monthly. |
|
|
| Baseline to 4 months |
| Composite Episodic Memory | Composite of 4 components. The Hopkins Verbal Learning Test (HVLT) of verbal learning. Subjects hear 12 words and repeat as many as possible. This is repeated twice for a total of 3 trials. 20 mins later the subject is asked to recall as many words as possible. Subjects also do a recognition trial with 24 words. Scores for immediate and delayed recall, and recognition are calculated.(Brandt J. Clin Neuropsych 1991;5:125-42). The Logical Memory (LM) test The LM test has 2 parts. In Part 1, subjects hear a story and recall as many pieces as possible immediately and after a 30 minute delay. Subjects receive a story unit score for accuracy of re-telling story details and a thematic score for recalling story themes. The higher the scores the better the performance. ( Wechsler D. The Wechsler Memory Scale-3rd Edition (WHM-III). Psycholog Corp, Harcourt, Inc.) Individual scores are converted to z-scores and averaged to form the composite. | Change a 4 months |
| 21615936 | Background | Legault C, Jennings JM, Katula JA, Dagenbach D, Gaussoin SA, Sink KM, Rapp SR, Rejeski WJ, Shumaker SA, Espeland MA; SHARP-P Study Group. Designing clinical trials for assessing the effects of cognitive training and physical activity interventions on cognitive outcomes: the Seniors Health and Activity Research Program Pilot (SHARP-P) study, a randomized controlled trial. BMC Geriatr. 2011 May 26;11:27. doi: 10.1186/1471-2318-11-27. |
| 23589390 | Background | Espeland MA, Katula JA, Rushing J, Kramer AF, Jennings JM, Sink KM, Nadkarni NK, Reid KF, Castro CM, Church T, Kerwin DR, Williamson JD, Marottoli RA, Rushing S, Marsiske M, Rapp SR; LIFE Study Group. Performance of a computer-based assessment of cognitive function measures in two cohorts of seniors. Int J Geriatr Psychiatry. 2013 Dec;28(12):1239-50. doi: 10.1002/gps.3949. Epub 2013 Apr 16. |
| 21229597 | Derived | Espeland MA, Rapp SR, Katula JA, Andrews LA, Felton D, Gaussoin SA, Dagenbach D, Legault C, Jennings JM, Sink KM; SHARP-P Study Group. Telephone interview for cognitive status (TICS) screening for clinical trials of physical activity and cognitive training: the seniors health and activity research program pilot (SHARP-P) study. Int J Geriatr Psychiatry. 2011 Feb;26(2):135-43. doi: 10.1002/gps.2503. |
| BG001 | Cognitive Training | The Cognitive Training (CT) intervention was developed to improve consciously-controlled memory processing or recollection of episodic memory information. Sessions were center-based, conducted via computer, carried out with small groups, and monitored by skilled trainers. Training consisted of four consecutive 10-12 min sessions per day, administered two times per week for two months, which then tapered to one time per week for two additional months. For each session, participants studied a list of 30 words, followed by a recognition test consisting of the 30 studied words and 30 new words with each new word repeated once, and asked to respond "yes" to study words and "no" to the new items both times they occurred. Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6. |
| BG002 | Combined Intervention | The Combined Intervention (PACT) was designed so that participants received both cognitive and physical activity training on the same day. To avoid the potential impact of physical fatigue on cognitive training, the cognitive treatment was delivered prior to the physical activity treatment. It included both the PA and CT interventions. Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions. Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6. |
| BG003 | Healthy Aging | The Healthy Aging Education control intervention consisted of weekly lectures based on health education and was based on a program developed by the Lifestyle Interventions and Independence for Elders pilot trial [Rejeski, 2005; LIFE, 2006]. Topics such as medications, foot care, traveling and nutrition were covered. The purpose of the intervention was to provide contact time with participants. Healthy Aging Education (HAE): One 1-hour lecture each week for 3 months, then monthly. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| 400 meter walk time | Mean | Standard Deviation | Seconds |
|
| Modified MiniMental State Exam Score | The Modified Mini Mental State Exam (3MS) Memory Functioning questionnaire asks the participant to rate on a scale of 1 (always) to 7 (never) how often remembering something presents a problem. In order to participate, subjects had to score at least an 88 or greater if their education level is greater than 8 years and if education level was 0-8 years, scores had to be at least an 80 or higher. The possible scores (units on a scale) range from 0 to 100, with higher scores reflecting better global cognitive functioning. | Mean | Standard Deviation | Units on a scale |
|
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|
|
|
| Secondary | Change in Executive Function: Z-score Formed by Averaging the Individual Z-scores From the Five Tests Listed Below. | Composite of 5 tasks: Self-Ordered Pointing Task of planning, working memory, and monitoring. Subjects view 16 abstract shapes and choose a shape so that each is selected by the 16th trial and none is chosen more than once. (Eriksen, Percept Psychophysiology 1974;16:143-49). N-Back Test of working memory. Subjects see individual letters and indicate whether the letter is the same as the nth back letter, with n equal to 1 and 2. (Dobbs, Psychol Aging 1989;4:500-3.) Eriksen flanker task of response incompatibility. Subjects see an arrow facing either right or left and indicate the direction.The target displays can be neutral congruent, or incongruent. (Eriksen, Percept Psychophys 1974;16:143-49.) Trail Making Test-Part B of alternating attention. Subjects connect 25 labeled circles and are scored by completion time. The lower the scores the better the performance. See details in the primary outcome. Raw scores for each test were converted to z-scores. | Participants assessed at 4 months -- note some dropouts occurred | Posted | Mean | Standard Error | z-scores (e.g. SD units) | Baseline to 4 months |
|
|
|
| Secondary | Composite Episodic Memory | Composite of 4 components. The Hopkins Verbal Learning Test (HVLT) of verbal learning. Subjects hear 12 words and repeat as many as possible. This is repeated twice for a total of 3 trials. 20 mins later the subject is asked to recall as many words as possible. Subjects also do a recognition trial with 24 words. Scores for immediate and delayed recall, and recognition are calculated.(Brandt J. Clin Neuropsych 1991;5:125-42). The Logical Memory (LM) test The LM test has 2 parts. In Part 1, subjects hear a story and recall as many pieces as possible immediately and after a 30 minute delay. Subjects receive a story unit score for accuracy of re-telling story details and a thematic score for recalling story themes. The higher the scores the better the performance. ( Wechsler D. The Wechsler Memory Scale-3rd Edition (WHM-III). Psycholog Corp, Harcourt, Inc.) Individual scores are converted to z-scores and averaged to form the composite. | Participants assessed at 4 months | Posted | Mean | Standard Error | z-scores (e.g. SD units) | Change a 4 months |
|
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 8 |
| 18 |
| EG001 | Cognitive Training | The Cognitive Training (CT) intervention was developed to improve consciously-controlled memory processing or recollection of episodic memory information. Sessions were center-based, conducted via computer, carried out with small groups, and monitored by skilled trainers. Training consisted of four consecutive 10-12 min sessions per day, administered two times per week for two months, which then tapered to one time per week for two additional months. For each session, participants studied a list of 30 words, followed by a recognition test consisting of the 30 studied words and 30 new words with each new word repeated once, and asked to respond "yes" to study words and "no" to the new items both times they occurred. Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6. | 0 | 18 | 1 | 18 | 5 | 18 |
| EG002 | Combined Intervention | The Combined Intervention (PACT) was designed so that participants received both cognitive and physical activity training on the same day. To avoid the potential impact of physical fatigue on cognitive training, the cognitive treatment was delivered prior to the physical activity treatment. It included both the PA and CT interventions. Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions. Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6. | 0 | 19 | 0 | 19 | 6 | 19 |
| EG003 | Healthy Aging | The Healthy Aging Education control intervention consisted of weekly lectures based on health education and was based on a program developed by the Lifestyle Interventions and Independence for Elders pilot trial [Rejeski, 2005; LIFE, 2006]. Topics such as medications, foot care, traveling and nutrition were covered. The purpose of the intervention was to provide contact time with participants. Healthy Aging Education (HAE): One 1-hour lecture each week for 3 months, then monthly. | 0 | 18 | 0 | 18 | 1 | 18 |
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| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Marginal comparisons of cognitive training versus no cognitive training
| ANOVA |
| 0.42 |
| Mean Difference (Net) |
| -0.16 |
| Standard Error of the Mean |
| 0.29 |
| 2-Sided |
| Equivalence |
Two Sided Test of Mean Difference from baseline |