Trial Outcomes & Findings for Community-based Intervention Effects on Older Adults' Physical Activity (NCT NCT03326141)
NCT ID: NCT03326141
Last Updated: 2024-04-24
Results Overview
Average weekly minutes of total physical activity per week (light, moderate and vigorous intensities) as captured from PAM data (Fitbit Charge-2)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
309 participants
Primary outcome timeframe
Baseline and Post-Intervention (one week, six months, twelve months)
Results posted on
2024-04-24
Participant Flow
Participant milestones
| Measure |
Otago+PAM+Health / Wellness Topics
Condition 1:
Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
Health and wellness information (attention control content) guided by content in the National Instituteon Aging (NIA) and Centers for Disease Control and Prevention websites.
|
Otago + PAM + Interpersonal Strategies
Condition 2:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.
|
Otago, PAM, Intrapersonal Strategies
Condition 3:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.
|
Otago,PAM, Inter+Intra Strategies
Condition 4:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.
4. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
78
|
78
|
76
|
77
|
|
Overall Study
COMPLETED
|
77
|
76
|
74
|
75
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Community-based Intervention Effects on Older Adults' Physical Activity
Baseline characteristics by cohort
| Measure |
Otago+PAM+Health / Wellness Topics
n=78 Participants
Condition 1:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Health and wellness information (attention control content) guided by content in the National Instituteon Aging (NIA) and Centers for Disease Control and Prevention websites.
|
Otago + PAM + Interpersonal Strategies
n=78 Participants
Condition 2:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.
|
Otago, PAM, Intrapersonal Strategies
n=76 Participants
Condition 3:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.
|
Otago,PAM, Inter+Intra Strategies
n=77 Participants
Condition 4:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.
4. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements
|
Total
n=309 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
77.8 years
STANDARD_DEVIATION 5 • n=93 Participants
|
77.7 years
STANDARD_DEVIATION 5 • n=4 Participants
|
77.3 years
STANDARD_DEVIATION 5 • n=27 Participants
|
76.6 years
STANDARD_DEVIATION 5.1 • n=483 Participants
|
77.4 years
STANDARD_DEVIATION 5 • n=36 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
59 Participants
n=27 Participants
|
58 Participants
n=483 Participants
|
240 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
69 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
48 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
67 Participants
n=483 Participants
|
255 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline and Post-Intervention (one week, six months, twelve months)Population: Number analyzed at baseline and post-intervention (one week, six months, twelve months) represent the number of participants in the study at that time. Numbers decrease across longitudinal time points due to participant withdrawal or loss to follow up
Average weekly minutes of total physical activity per week (light, moderate and vigorous intensities) as captured from PAM data (Fitbit Charge-2)
Outcome measures
| Measure |
Otago+PAM+Health / Wellness Topics
n=78 Participants
Condition 1:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Health and wellness information (attention control content) guided by content in the National Instituteon Aging (NIA) and Centers for Disease Control and Prevention websites.
|
Otago + PAM + Interpersonal Strategies
n=78 Participants
Condition 2:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.
|
Otago, PAM, Intrapersonal Strategies
n=76 Participants
Condition 3:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.
|
Otago,PAM, Inter+Intra Strategies
n=77 Participants
Condition 4:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.
|
|---|---|---|---|---|
|
Quantity of Physical Activity Measured Objectively
Baseline
|
177.9 minutes per day
Standard Deviation 62.2
|
167.7 minutes per day
Standard Deviation 79.1
|
185.9 minutes per day
Standard Deviation 70.5
|
177.9 minutes per day
Standard Deviation 72.7
|
|
Quantity of Physical Activity Measured Objectively
one week post-intervention
|
180.5 minutes per day
Standard Deviation 68.5
|
193.1 minutes per day
Standard Deviation 82.1
|
181 minutes per day
Standard Deviation 68.2
|
209.1 minutes per day
Standard Deviation 79.2
|
|
Quantity of Physical Activity Measured Objectively
six months post-intervention
|
180 minutes per day
Standard Deviation 73.8
|
185.7 minutes per day
Standard Deviation 84
|
175.1 minutes per day
Standard Deviation 68.9
|
198 minutes per day
Standard Deviation 78
|
|
Quantity of Physical Activity Measured Objectively
twelve months post-intervention
|
174.3 minutes per day
Standard Deviation 72.0
|
190.3 minutes per day
Standard Deviation 99.1
|
167.7 minutes per day
Standard Deviation 68.6
|
192.9 minutes per day
Standard Deviation 80.4
|
PRIMARY outcome
Timeframe: Baseline and Post-Intervention (one week, six months, twelve months)Population: Number analyzed at baseline and post-intervention (one week, six months, twelve months) represent the number of participants in the study at that time. Numbers decrease across longitudinal time points due to participant withdrawal or loss to follow up
Self-report Measure of Physical Activity. PASE is a validated questionnaire to measure the amount of physical activity in people over the age of 65 including types (e.g., walking, recreational, exercise, housework, care-giving). Scores, accounting for frequency, duration and intensity of physical activity are calculated and typically range from 0 to 793, with higher value representing more physical activity.
Outcome measures
| Measure |
Otago+PAM+Health / Wellness Topics
n=78 Participants
Condition 1:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Health and wellness information (attention control content) guided by content in the National Instituteon Aging (NIA) and Centers for Disease Control and Prevention websites.
|
Otago + PAM + Interpersonal Strategies
n=78 Participants
Condition 2:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.
|
Otago, PAM, Intrapersonal Strategies
n=76 Participants
Condition 3:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.
|
Otago,PAM, Inter+Intra Strategies
n=77 Participants
Condition 4:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.
|
|---|---|---|---|---|
|
Physical Activity Scale for the Elderly (PASE)
Baseline
|
102.2 Total PASE Score
Standard Error 46.4
|
108.3 Total PASE Score
Standard Error 66.6
|
110.6 Total PASE Score
Standard Error 44
|
101.8 Total PASE Score
Standard Error 48.5
|
|
Physical Activity Scale for the Elderly (PASE)
One week post-intervention
|
111.1 Total PASE Score
Standard Error 47.3
|
119.2 Total PASE Score
Standard Error 69.9
|
120.7 Total PASE Score
Standard Error 56.2
|
121.1 Total PASE Score
Standard Error 58.7
|
|
Physical Activity Scale for the Elderly (PASE)
Six months post-intervention
|
106.7 Total PASE Score
Standard Error 53.0
|
118.2 Total PASE Score
Standard Error 65.1
|
119.5 Total PASE Score
Standard Error 65.8
|
112.2 Total PASE Score
Standard Error 60.1
|
|
Physical Activity Scale for the Elderly (PASE)
Twelve months post-intervention
|
107.1 Total PASE Score
Standard Error 60.0
|
113.8 Total PASE Score
Standard Error 66.8
|
123.0 Total PASE Score
Standard Error 92.3
|
112.4 Total PASE Score
Standard Error 60.9
|
SECONDARY outcome
Timeframe: 12 months post interventionFalls per person year, assessed via prospective monthly calendars
Outcome measures
| Measure |
Otago+PAM+Health / Wellness Topics
n=77 Participants
Condition 1:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Health and wellness information (attention control content) guided by content in the National Instituteon Aging (NIA) and Centers for Disease Control and Prevention websites.
|
Otago + PAM + Interpersonal Strategies
n=76 Participants
Condition 2:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.
|
Otago, PAM, Intrapersonal Strategies
n=74 Participants
Condition 3:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.
|
Otago,PAM, Inter+Intra Strategies
n=75 Participants
Condition 4:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.
|
|---|---|---|---|---|
|
Fall Rate
|
0.9 Falls per person year
|
1.0 Falls per person year
|
0.9 Falls per person year
|
1.1 Falls per person year
|
SECONDARY outcome
Timeframe: 12 months post interventionNumber of injuries from falls was measured via prospective falls calendars mailed to participants monthly with return addressed/stamped envelopes. Circumstances and injuries related to each fall were documented on the calendars. Calendar documentation each fall was verified and detailed through phone conversations between participants and trained research staff. Moderate and Major injuries from falls were categorized according to the Agency for Healthcare Research and Quality with moderate injuries defined as necessitating sutures, skin glue, splinting, and or involving muscle or joint strain. Major injuries were defined as those associated with internal injuries or a need for surgery, casting, traction, or neurological consults.
Outcome measures
| Measure |
Otago+PAM+Health / Wellness Topics
n=77 Participants
Condition 1:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Health and wellness information (attention control content) guided by content in the National Instituteon Aging (NIA) and Centers for Disease Control and Prevention websites.
|
Otago + PAM + Interpersonal Strategies
n=76 Participants
Condition 2:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.
|
Otago, PAM, Intrapersonal Strategies
n=74 Participants
Condition 3:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.
|
Otago,PAM, Inter+Intra Strategies
n=75 Participants
Condition 4:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.
|
|---|---|---|---|---|
|
Number of Participants With Moderate or Major Injuries From Falls
Number of moderate injurious falls
|
6 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Moderate or Major Injuries From Falls
Number of major injurious falls
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and post-intervention: one-week, six months, and 12 monthsPopulation: Number analyzed at baseline and post-intervention (one week, six months, twelve months) represent the number of participants in the study at that time. Numbers decrease across longitudinal time points due to participant withdrawal or loss to follow up
Using the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Questionnaire 1.2. Two constructs from this questionnaire were converted to t scores: self-reported physical health and self-reported mental health. . Mean t scores are 50, which indicates the adult population mean with a standard deviation of 10. Higher t scores are considered better, or healthier, for self-reported physical health and mental health. No clinically relevant thresholds were described in this study.
Outcome measures
| Measure |
Otago+PAM+Health / Wellness Topics
n=78 Participants
Condition 1:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Health and wellness information (attention control content) guided by content in the National Instituteon Aging (NIA) and Centers for Disease Control and Prevention websites.
|
Otago + PAM + Interpersonal Strategies
n=78 Participants
Condition 2:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.
|
Otago, PAM, Intrapersonal Strategies
n=76 Participants
Condition 3:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.
|
Otago,PAM, Inter+Intra Strategies
n=77 Participants
Condition 4:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.
|
|---|---|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 Global Health
Physical Health: Baseline
|
39.2 T score
Standard Deviation 4.9
|
39.5 T score
Standard Deviation 5.3
|
39.1 T score
Standard Deviation 4.9
|
40 T score
Standard Deviation 5.1
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 Global Health
Physical Health: Post-intervention, One week
|
40.2 T score
Standard Deviation 4.7
|
39.6 T score
Standard Deviation 5.5
|
39.6 T score
Standard Deviation 4.6
|
40.5 T score
Standard Deviation 5.0
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 Global Health
Physical Health: Post-intervention, six months
|
38.7 T score
Standard Deviation 5.2
|
38.7 T score
Standard Deviation 5.6
|
39.2 T score
Standard Deviation 4.5
|
40.0 T score
Standard Deviation 5.1
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 Global Health
Physical Health 12 months post-intervention
|
39.5 T score
Standard Deviation 5.3
|
39.1 T score
Standard Deviation 6.2
|
38.9 T score
Standard Deviation 5.1
|
39.3 T score
Standard Deviation 5.1
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 Global Health
Mental Health: Baseline
|
50.8 T score
Standard Deviation 7.4
|
52.3 T score
Standard Deviation 7.9
|
51.8 T score
Standard Deviation 8.0
|
52.9 T score
Standard Deviation 8.1
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 Global Health
Mental Health: Post-intervention, One week
|
53.1 T score
Standard Deviation 7.1
|
52.4 T score
Standard Deviation 7.9
|
52.2 T score
Standard Deviation 8.3
|
53.8 T score
Standard Deviation 8.0
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 Global Health
Mental Health: Post-intervention, Six months
|
51.4 T score
Standard Deviation 7.0
|
50.6 T score
Standard Deviation 8.2
|
51.7 T score
Standard Deviation 7.4
|
52.8 T score
Standard Deviation 8.4
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 Global Health
Mental Health: Post-intervention, Twelve months
|
51.1 T score
Standard Deviation 7.4
|
50.3 T score
Standard Deviation 8.3
|
50.3 T score
Standard Deviation 7.4
|
49.9 T score
Standard Deviation 8.3
|
Adverse Events
Otago+PAM+Health / Wellness Topics
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Otago + PAM + Interpersonal Strategies
Serious events: 0 serious events
Other events: 7 other events
Deaths: 2 deaths
Otago, PAM, Intrapersonal Strategies
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Otago,PAM, Inter+Intra Strategies
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Otago+PAM+Health / Wellness Topics
n=77 participants at risk
Condition 1:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Health and wellness information (attention control content) guided by content in the National Instituteon Aging (NIA) and Centers for Disease Control and Prevention websites.
|
Otago + PAM + Interpersonal Strategies
n=76 participants at risk
Condition 2:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.
|
Otago, PAM, Intrapersonal Strategies
n=74 participants at risk
Condition 3:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.
|
Otago,PAM, Inter+Intra Strategies
n=75 participants at risk
Condition 4:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.
4. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movement
|
|---|---|---|---|---|
|
General disorders
cancer
|
0.00%
0/77 • 12 months
|
0.00%
0/76 • 12 months
|
0.00%
0/74 • 12 months
|
1.3%
1/75 • Number of events 1 • 12 months
|
|
Cardiac disorders
Stroke
|
0.00%
0/77 • 12 months
|
0.00%
0/76 • 12 months
|
0.00%
0/74 • 12 months
|
1.3%
1/75 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Otago+PAM+Health / Wellness Topics
n=77 participants at risk
Condition 1:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Health and wellness information (attention control content) guided by content in the National Instituteon Aging (NIA) and Centers for Disease Control and Prevention websites.
|
Otago + PAM + Interpersonal Strategies
n=76 participants at risk
Condition 2:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.
|
Otago, PAM, Intrapersonal Strategies
n=74 participants at risk
Condition 3:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.
|
Otago,PAM, Inter+Intra Strategies
n=75 participants at risk
Condition 4:
1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.
4. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movement
|
|---|---|---|---|---|
|
General disorders
Pain
|
2.6%
2/77 • Number of events 2 • 12 months
|
1.3%
1/76 • Number of events 1 • 12 months
|
1.4%
1/74 • Number of events 1 • 12 months
|
1.3%
1/75 • Number of events 1 • 12 months
|
|
General disorders
Fall
|
0.00%
0/77 • 12 months
|
1.3%
1/76 • Number of events 1 • 12 months
|
0.00%
0/74 • 12 months
|
0.00%
0/75 • 12 months
|
|
General disorders
fracture
|
0.00%
0/77 • 12 months
|
2.6%
2/76 • Number of events 2 • 12 months
|
1.4%
1/74 • Number of events 1 • 12 months
|
0.00%
0/75 • 12 months
|
|
Infections and infestations
Infection
|
0.00%
0/77 • 12 months
|
1.3%
1/76 • Number of events 1 • 12 months
|
1.4%
1/74 • Number of events 1 • 12 months
|
0.00%
0/75 • 12 months
|
|
General disorders
Polymyalgia rheumatica--unrelated
|
0.00%
0/77 • 12 months
|
1.3%
1/76 • Number of events 1 • 12 months
|
0.00%
0/74 • 12 months
|
0.00%
0/75 • 12 months
|
|
General disorders
cancer
|
0.00%
0/77 • 12 months
|
0.00%
0/76 • 12 months
|
0.00%
0/74 • 12 months
|
1.3%
1/75 • Number of events 1 • 12 months
|
|
General disorders
lung illness
|
0.00%
0/77 • 12 months
|
0.00%
0/76 • 12 months
|
0.00%
0/74 • 12 months
|
1.3%
1/75 • Number of events 1 • 12 months
|
|
General disorders
hyponatremia
|
0.00%
0/77 • 12 months
|
1.3%
1/76 • Number of events 1 • 12 months
|
0.00%
0/74 • 12 months
|
0.00%
0/75 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place