Trial Outcomes & Findings for Seniors Health and Activity Research Program-Pilot (NCT NCT00688155)
NCT ID: NCT00688155
Last Updated: 2018-01-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
73 participants
Primary outcome timeframe
Changes from baseline at 4 months in z-scores.
Results posted on
2018-01-04
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
19
|
18
|
|
Overall Study
COMPLETED
|
16
|
16
|
18
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
1
|
1
|
Baseline Characteristics
Seniors Health and Activity Research Program-Pilot
Baseline characteristics by cohort
| Measure |
Physical Activity Training
n=18 Participants
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.
|
Cognitive Training
n=18 Participants
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.
|
Combined Intervention
n=19 Participants
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.
|
Healthy Aging
n=18 Participants
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.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
77.5 years
STANDARD_DEVIATION 4.8 • n=99 Participants
|
76.0 years
STANDARD_DEVIATION 5.2 • n=107 Participants
|
76.9 years
STANDARD_DEVIATION 4.0 • n=206 Participants
|
75.4 years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
76.4 years
STANDARD_DEVIATION 4.7 • n=31 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
37 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
36 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
African-American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
66 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
73 Participants
n=31 Participants
|
|
400 meter walk time
|
360 Seconds
STANDARD_DEVIATION 48 • n=99 Participants
|
331 Seconds
STANDARD_DEVIATION 50 • n=107 Participants
|
347 Seconds
STANDARD_DEVIATION 56 • n=206 Participants
|
331 Seconds
STANDARD_DEVIATION 66 • n=7 Participants
|
342 Seconds
STANDARD_DEVIATION 55 • n=31 Participants
|
|
Modified MiniMental State Exam Score
|
94.6 Units on a scale
STANDARD_DEVIATION 3.9 • n=99 Participants
|
95.6 Units on a scale
STANDARD_DEVIATION 3.4 • n=107 Participants
|
94.6 Units on a scale
STANDARD_DEVIATION 4.3 • n=206 Participants
|
94.3 Units on a scale
STANDARD_DEVIATION 2.4 • n=7 Participants
|
94.8 Units on a scale
STANDARD_DEVIATION 3.5 • n=31 Participants
|
PRIMARY outcome
Timeframe: Changes from baseline at 4 months in z-scores.Population: Participants assessed at four months post-randomization. Note that this does not include all who were randomized due to dropout.
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.
Outcome measures
| Measure |
Physical Activity Training
n=16 Participants
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.
|
Cognitive Training
n=16 Participants
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.
|
Combined Intervention
n=19 Participants
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.
|
Healthy Aging
n=17 Participants
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.
|
|---|---|---|---|---|
|
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.
|
0.71 z-scores (e.g.Standard Deviation Units)
Standard Error 0.18
|
0.62 z-scores (e.g.Standard Deviation Units)
Standard Error 0.18
|
0.71 z-scores (e.g.Standard Deviation Units)
Standard Error 0.17
|
0.65 z-scores (e.g.Standard Deviation Units)
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline to 4 monthsPopulation: Participants assessed at 4 months -- note some dropouts occurred
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.
Outcome measures
| Measure |
Physical Activity Training
n=16 Participants
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.
|
Cognitive Training
n=16 Participants
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.
|
Combined Intervention
n=19 Participants
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.
|
Healthy Aging
n=17 Participants
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.
|
|---|---|---|---|---|
|
Change in Executive Function: Z-score Formed by Averaging the Individual Z-scores From the Five Tests Listed Below.
|
0.32 z-scores (e.g. SD units)
Standard Error 0.19
|
0.58 z-scores (e.g. SD units)
Standard Error 0.19
|
0.60 z-scores (e.g. SD units)
Standard Error 0.18
|
0.58 z-scores (e.g. SD units)
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Change a 4 monthsPopulation: Participants assessed at 4 months
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.
Outcome measures
| Measure |
Physical Activity Training
n=16 Participants
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.
|
Cognitive Training
n=16 Participants
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.
|
Combined Intervention
n=19 Participants
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.
|
Healthy Aging
n=17 Participants
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.
|
|---|---|---|---|---|
|
Composite Episodic Memory
|
0.84 z-scores (e.g. SD units)
Standard Error 0.21
|
0.42 z-scores (e.g. SD units)
Standard Error 0.21
|
0.56 z-scores (e.g. SD units)
Standard Error 0.20
|
0.47 z-scores (e.g. SD units)
Standard Error 0.21
|
Adverse Events
Physical Activity Training
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cognitive Training
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Combined Intervention
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Healthy Aging
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Physical Activity Training
n=18 participants at risk
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.
|
Cognitive Training
n=18 participants at risk
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.
|
Combined Intervention
n=19 participants at risk
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.
|
Healthy Aging
n=18 participants at risk
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.
|
|---|---|---|---|---|
|
Vascular disorders
Stroke
|
0.00%
0/18 • 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.
|
5.6%
1/18 • Number of events 1 • 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.
|
0.00%
0/19 • 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.
|
0.00%
0/18 • 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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Other adverse events
| Measure |
Physical Activity Training
n=18 participants at risk
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.
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Cognitive Training
n=18 participants at risk
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.
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Combined Intervention
n=19 participants at risk
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.
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Healthy Aging
n=18 participants at risk
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.
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Musculoskeletal and connective tissue disorders
Non-serious
|
44.4%
8/18 • Number of events 10 • 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.
|
27.8%
5/18 • Number of events 5 • 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.
|
31.6%
6/19 • Number of events 6 • 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.
|
5.6%
1/18 • Number of events 1 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place