Trial Outcomes & Findings for Enhancing Quality of Life Through Exercise: A Tele-Rehabilitation Approach (NCT NCT02833935)
NCT ID: NCT02833935
Last Updated: 2023-09-18
Results Overview
Measure to assess changes in autonomous and controlled types of motivation for reasons why one would exercise/engage in physical activity throughout the intervention. A total scale score range of 1 (not at all true) to 7 (very true) will be used to respond to 15 items. A mean score of participants' autonomous (6 items; " Because I personally believe it is the best thing for my health.") and controlled motivation (6 items; "Because I want others to approve of me.") will be calculated. A higher value indicates greater autonomous and or controlled types of motivation.
COMPLETED
NA
24 participants
Baseline, Week 6, and Week 10
2023-09-18
Participant Flow
Participant milestones
| Measure |
Physical Activity Intervention Group
Physical Activity Intervention: The PA intervention will be delivered in a virtual face-to-face format using the secure and confidential "Remote Education, Augmented Communication, Training and Supervision" online video-based software. Intervention participants will receive 8 PA sessions over 2 months (1/week), following collaborator specific telephone-based PA counselling protocol. The counsellor will individually tailor her approach to each participant by understanding the participant's past and current PA experiences, motives to be physically active, salient concerns and barriers regarding PA, and physical home environment. Throughout the intervention, the PA counsellor and participants will co-construct and collaboratively adapt the intervention with the participants.
|
Control Group
Control Group: For participants assigned to the control group, they will be asked to continue with their regular routine for the next two months. Otherwise, the participants in this group will be asked to complete the follow-up baseline questionnaires at 6 and 10 weeks post-baseline. They will be contacted by a physical activity counsellor at the end of the 10-week period.
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|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One missing data
Baseline characteristics by cohort
| Measure |
Physical Activity Intervention Group
n=12 Participants
Participants will complete a baseline questionnaire (week 1) about their demographic information, self-determination theory variables, their current physical activity, and other psychological indicators. They will complete the same questionnaire at two additional time points. First, about halfway through the intervention (week 6), and then at the end (week 10). Participants in the physical activity intervention group will also receive 8 1-hour physical activity sessions over 2 months (1/week) with a trained physical activity counselor through a video-based internet platform.
Physical Activity Intervention: The PA intervention will be delivered in a virtual face-to-face format using the secure and confidential "Remote Education, Augmented Communication, Training and Supervision" online video-based software. Intervention participants will receive 8 PA sessions over 2 months (1/week), following collaborator specific telephone-based PA counselling protocol.
|
Control Group
n=12 Participants
Control Group: For participants assigned to the control group, they will be asked to continue with their regular routine for the next two months. Otherwise, the participants in this group will be asked to complete the follow-up baseline questionnaires at 6 and 10 weeks post-baseline. They will be contacted by a physical activity counsellor at the end of the 10-week period.
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Total
n=24 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
49.64 years
STANDARD_DEVIATION 12.64 • n=12 Participants
|
53 years
STANDARD_DEVIATION 11.29 • n=12 Participants
|
50.50 years
STANDARD_DEVIATION 12.34 • n=24 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=11 Participants • One missing data
|
2 Participants
n=12 Participants • One missing data
|
7 Participants
n=23 Participants • One missing data
|
|
Sex: Female, Male
Male
|
6 Participants
n=11 Participants • One missing data
|
10 Participants
n=12 Participants • One missing data
|
16 Participants
n=23 Participants • One missing data
|
|
Race/Ethnicity, Customized
Race · White
|
12 Participants
n=12 Participants
|
11 Participants
n=12 Participants
|
23 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=24 Participants
|
|
Region of Enrollment
Canada
|
11 participants
n=12 Participants
|
10 participants
n=12 Participants
|
21 participants
n=24 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=12 Participants
|
2 participants
n=12 Participants
|
3 participants
n=24 Participants
|
|
Mobility Mode
Manual Wheelchair
|
8 Participants
n=11 Participants • Missing data
|
7 Participants
n=11 Participants • Missing data
|
15 Participants
n=22 Participants • Missing data
|
|
Mobility Mode
Other (e.g., cane)
|
3 Participants
n=11 Participants • Missing data
|
4 Participants
n=11 Participants • Missing data
|
7 Participants
n=22 Participants • Missing data
|
|
Cause of Spinal Cord Injury
Traumatic
|
8 Participants
n=12 Participants
|
8 Participants
n=12 Participants
|
16 Participants
n=24 Participants
|
|
Cause of Spinal Cord Injury
Non-Traumatic
|
4 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
8 Participants
n=24 Participants
|
|
Language
Francophone
|
8 Participants
n=12 Participants
|
9 Participants
n=12 Participants
|
17 Participants
n=24 Participants
|
|
Language
Anglophone
|
4 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
7 Participants
n=24 Participants
|
|
Years since Spinal Cord Injury
|
15.8 years
STANDARD_DEVIATION 14.51 • n=12 Participants
|
15.10 years
STANDARD_DEVIATION 10.89 • n=12 Participants
|
15.45 years
STANDARD_DEVIATION 12.85 • n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6, and Week 10Measure to assess changes in autonomous and controlled types of motivation for reasons why one would exercise/engage in physical activity throughout the intervention. A total scale score range of 1 (not at all true) to 7 (very true) will be used to respond to 15 items. A mean score of participants' autonomous (6 items; " Because I personally believe it is the best thing for my health.") and controlled motivation (6 items; "Because I want others to approve of me.") will be calculated. A higher value indicates greater autonomous and or controlled types of motivation.
Outcome measures
| Measure |
Physical Activity Intervention Group
n=10 Participants
Physical Activity Intervention: The PA intervention will be delivered in a virtual face-to-face format using the secure and confidential "Remote Education, Augmented Communication, Training and Supervision" online video-based software. Intervention participants will receive 8 PA sessions over 2 months (1/week), following collaborator specific telephone-based PA counselling protocol. The counsellor will individually tailor her approach to each participant by understanding the participant's past and current PA experiences, motives to be physically active, salient concerns and barriers regarding PA, and physical home environment. Throughout the intervention, the PA counsellor and participants will co-construct and collaboratively adapt the intervention with the participants.
|
Control Group
n=12 Participants
Control Group: For participants assigned to the control group, they will be asked to continue with their regular routine for the next two months. Otherwise, the participants in this group will be asked to complete the follow-up baseline questionnaires at 6 and 10 weeks post-baseline. They will be contacted by a physical activity counsellor at the end of the 10-week period.
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|---|---|---|
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Treatment Self-Regulation for Exercise Scale
Autonomous Motivation (Baseline)
|
5.75 score on a scale
Standard Deviation 1.50
|
5.51 score on a scale
Standard Deviation 1.15
|
|
Treatment Self-Regulation for Exercise Scale
Controlled Motivation (Baseline)
|
3.23 score on a scale
Standard Deviation 1.40
|
2.63 score on a scale
Standard Deviation 0.89
|
|
Treatment Self-Regulation for Exercise Scale
Autonomous Motivation (6 weeks)
|
6.33 score on a scale
Standard Deviation 0.75
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5.63 score on a scale
Standard Deviation 0.98
|
|
Treatment Self-Regulation for Exercise Scale
Controlled Motivation (6 weeks)
|
2.55 score on a scale
Standard Deviation 1.17
|
2.79 score on a scale
Standard Deviation 0.88
|
|
Treatment Self-Regulation for Exercise Scale
Autonomous Motivation (10 weeks)
|
6.32 score on a scale
Standard Deviation 0.97
|
5.31 score on a scale
Standard Deviation 1.21
|
|
Treatment Self-Regulation for Exercise Scale
Controlled Motivation (10 weeks)
|
2.65 score on a scale
Standard Deviation 0.97
|
2.63 score on a scale
Standard Deviation 0.80
|
PRIMARY outcome
Timeframe: Baseline, Week 6, and Week 10Measure to assess changes during the intervention in the basic psychological needs for exercise as per self-determination theory. Data will be collected at baseline, week 6, and week 10 for both participant groups. On a 6-point likert scale ranging from 1 (false) to 6 (true), participants will respond to 18 items reflecting how they might feel when physically active. After summating all items, a total mean score was calculated for autonomy (6 items; "I feel free to exercise in my own way"), competence (6 items; "I feel that I am able to complete exercises that are personally challenging"), and relatedness (6 items; "I feel close to my exercise companions who appreciate how difficult exercise can be"). A higher value indicates greater need satisfaction. Total values are reported in the data table as a sum of all 3 categories (Score range is 3-18).
Outcome measures
| Measure |
Physical Activity Intervention Group
n=10 Participants
Physical Activity Intervention: The PA intervention will be delivered in a virtual face-to-face format using the secure and confidential "Remote Education, Augmented Communication, Training and Supervision" online video-based software. Intervention participants will receive 8 PA sessions over 2 months (1/week), following collaborator specific telephone-based PA counselling protocol. The counsellor will individually tailor her approach to each participant by understanding the participant's past and current PA experiences, motives to be physically active, salient concerns and barriers regarding PA, and physical home environment. Throughout the intervention, the PA counsellor and participants will co-construct and collaboratively adapt the intervention with the participants.
|
Control Group
n=12 Participants
Control Group: For participants assigned to the control group, they will be asked to continue with their regular routine for the next two months. Otherwise, the participants in this group will be asked to complete the follow-up baseline questionnaires at 6 and 10 weeks post-baseline. They will be contacted by a physical activity counsellor at the end of the 10-week period.
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|---|---|---|
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Psychological Needs for Exercise Questionnaire
Baseline
|
4.52 score on a scale
Standard Deviation 0.84
|
4.50 score on a scale
Standard Deviation 1.03
|
|
Psychological Needs for Exercise Questionnaire
6 weeks
|
4.36 score on a scale
Standard Deviation 0.96
|
4.61 score on a scale
Standard Deviation 0.70
|
|
Psychological Needs for Exercise Questionnaire
10 weeks
|
4.51 score on a scale
Standard Deviation 0.96
|
4.43 score on a scale
Standard Deviation 0.74
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SECONDARY outcome
Timeframe: Baseline, Week 6, and Week 10Questionnaire used to measure physical activity levels. Participants will be asked to indicate the frequency (days) and duration (in minutes) they engage in mild, moderate, and vigorous intensity activities over the last 7 days. Weekly minutes of total activity (mild, moderate, and vigorous) and of moderate and vigorous activity will be summed.
Outcome measures
| Measure |
Physical Activity Intervention Group
n=10 Participants
Physical Activity Intervention: The PA intervention will be delivered in a virtual face-to-face format using the secure and confidential "Remote Education, Augmented Communication, Training and Supervision" online video-based software. Intervention participants will receive 8 PA sessions over 2 months (1/week), following collaborator specific telephone-based PA counselling protocol. The counsellor will individually tailor her approach to each participant by understanding the participant's past and current PA experiences, motives to be physically active, salient concerns and barriers regarding PA, and physical home environment. Throughout the intervention, the PA counsellor and participants will co-construct and collaboratively adapt the intervention with the participants.
|
Control Group
n=12 Participants
Control Group: For participants assigned to the control group, they will be asked to continue with their regular routine for the next two months. Otherwise, the participants in this group will be asked to complete the follow-up baseline questionnaires at 6 and 10 weeks post-baseline. They will be contacted by a physical activity counsellor at the end of the 10-week period.
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|---|---|---|
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Leisure Time Physical Activity Questionnaire for People With Spinal Cord Injury
Total (Baseline)
|
116.70 Minutes
Standard Deviation 175.54
|
114.17 Minutes
Standard Deviation 208.82
|
|
Leisure Time Physical Activity Questionnaire for People With Spinal Cord Injury
Total (6 weeks)
|
375.82 Minutes
Standard Deviation 334.12
|
149.30 Minutes
Standard Deviation 194.75
|
|
Leisure Time Physical Activity Questionnaire for People With Spinal Cord Injury
Total (10 weeks)
|
505.82 Minutes
Standard Deviation 322.84
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253.36 Minutes
Standard Deviation 272.15
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SECONDARY outcome
Timeframe: Baseline, Week 6, and Week 10Measure to assess participation in daily and social activities. Participants will be presented with a list of 26 activities. For each activity, they are asked, "Do you participate in this activity?" Response options are "Yes, as much as I want" (4); "Yes, but less than I want"(3); "No, but I would like to" (2); and "No, but I don't want to" (1). An overall participation in daily and social activities score will be calculated as well as six sub-scale scores reflecting broad categories of participation will be summed. The 6 subscales are autonomous participation- indoors (7 items, range 7-28), autonomous participation-outdoors (6 items, range 6-24), family roles (4 items, range 4-16), health (2 items, range 2-8), social relationships (4 items, range 4-16), work-education (3 items, range 3-12). Each sub-scale is calculated by adding the scores of the individual items. A higher score of each category indicates greater participation.
Outcome measures
| Measure |
Physical Activity Intervention Group
n=10 Participants
Physical Activity Intervention: The PA intervention will be delivered in a virtual face-to-face format using the secure and confidential "Remote Education, Augmented Communication, Training and Supervision" online video-based software. Intervention participants will receive 8 PA sessions over 2 months (1/week), following collaborator specific telephone-based PA counselling protocol. The counsellor will individually tailor her approach to each participant by understanding the participant's past and current PA experiences, motives to be physically active, salient concerns and barriers regarding PA, and physical home environment. Throughout the intervention, the PA counsellor and participants will co-construct and collaboratively adapt the intervention with the participants.
|
Control Group
n=12 Participants
Control Group: For participants assigned to the control group, they will be asked to continue with their regular routine for the next two months. Otherwise, the participants in this group will be asked to complete the follow-up baseline questionnaires at 6 and 10 weeks post-baseline. They will be contacted by a physical activity counsellor at the end of the 10-week period.
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|---|---|---|
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Person-Perceived Participation in Daily Activities Questionnaire
work-education (baseline)
|
3.8 score on a scale
Standard Deviation 3.46
|
5.58 score on a scale
Standard Deviation 2.78
|
|
Person-Perceived Participation in Daily Activities Questionnaire
work-education (6 weeks)
|
3.6 score on a scale
Standard Deviation 3.31
|
6.45 score on a scale
Standard Deviation 2.16
|
|
Person-Perceived Participation in Daily Activities Questionnaire
Health Participation (baseline)
|
4.30 score on a scale
Standard Deviation 1.06
|
4.50 score on a scale
Standard Deviation 1.17
|
|
Person-Perceived Participation in Daily Activities Questionnaire
Health Participation (6 weeks)
|
5.20 score on a scale
Standard Deviation 0.92
|
4.09 score on a scale
Standard Deviation 1.30
|
|
Person-Perceived Participation in Daily Activities Questionnaire
Health Participation (10 weeks)
|
5.10 score on a scale
Standard Deviation 0.99
|
4.09 score on a scale
Standard Deviation 3.02
|
|
Person-Perceived Participation in Daily Activities Questionnaire
autonomous participation- indoors (baseline)
|
19.6 score on a scale
Standard Deviation 1.51
|
18.67 score on a scale
Standard Deviation 3.89
|
|
Person-Perceived Participation in Daily Activities Questionnaire
autonomous participation- indoors (6 weeks)
|
19.4 score on a scale
Standard Deviation 1.84
|
19.72 score on a scale
Standard Deviation 1.68
|
|
Person-Perceived Participation in Daily Activities Questionnaire
autonomous participation- indoors (10 weeks)
|
19.9 score on a scale
Standard Deviation 0.88
|
18.18 score on a scale
Standard Deviation 3.31
|
|
Person-Perceived Participation in Daily Activities Questionnaire
autonomous participation-outdoors (baseline)
|
12.2 score on a scale
Standard Deviation 4.13
|
14 score on a scale
Standard Deviation 3.41
|
|
Person-Perceived Participation in Daily Activities Questionnaire
autonomous participation-outdoors (6 weeks)
|
11.5 score on a scale
Standard Deviation 3.60
|
14.36 score on a scale
Standard Deviation 2.58
|
|
Person-Perceived Participation in Daily Activities Questionnaire
autonomous participation-outdoors (10 weeks)
|
13.1 score on a scale
Standard Deviation 3.38
|
13.27 score on a scale
Standard Deviation 2.76
|
|
Person-Perceived Participation in Daily Activities Questionnaire
family roles (baseline)
|
9.5 score on a scale
Standard Deviation 1.84
|
8.92 score on a scale
Standard Deviation 2.87
|
|
Person-Perceived Participation in Daily Activities Questionnaire
family roles (6 weeks)
|
9.7 score on a scale
Standard Deviation 1.57
|
10 score on a scale
Standard Deviation 1.61
|
|
Person-Perceived Participation in Daily Activities Questionnaire
family roles (10 weeks)
|
9.3 score on a scale
Standard Deviation 0.82
|
8.55 score on a scale
Standard Deviation 2.42
|
|
Person-Perceived Participation in Daily Activities Questionnaire
social relationships (baseline)
|
11 score on a scale
Standard Deviation 0.82
|
10.5 score on a scale
Standard Deviation 2.39
|
|
Person-Perceived Participation in Daily Activities Questionnaire
social relationships (6 weeks)
|
10.8 score on a scale
Standard Deviation 1.14
|
10.63 score on a scale
Standard Deviation 1.21
|
|
Person-Perceived Participation in Daily Activities Questionnaire
social relationships (10 weeks)
|
10.7 score on a scale
Standard Deviation 1.95
|
10.36 score on a scale
Standard Deviation 1.43
|
|
Person-Perceived Participation in Daily Activities Questionnaire
work-education (10 weeks)
|
4.2 score on a scale
Standard Deviation 3.68
|
4.91 score on a scale
Standard Deviation 3.02
|
SECONDARY outcome
Timeframe: Baseline, Week 6, and Week 10Standardized and validated quality of life measure that asks 11 questions about satisfaction in various areas of life, including life in general, vocation, financial situation, leisure, social/friends/family, sexual life, family life, and physical and mental health (1=very dissatisfying to 6=very satisfying). The mean score of the 11 items will be calculated for this measure.
Outcome measures
| Measure |
Physical Activity Intervention Group
n=10 Participants
Physical Activity Intervention: The PA intervention will be delivered in a virtual face-to-face format using the secure and confidential "Remote Education, Augmented Communication, Training and Supervision" online video-based software. Intervention participants will receive 8 PA sessions over 2 months (1/week), following collaborator specific telephone-based PA counselling protocol. The counsellor will individually tailor her approach to each participant by understanding the participant's past and current PA experiences, motives to be physically active, salient concerns and barriers regarding PA, and physical home environment. Throughout the intervention, the PA counsellor and participants will co-construct and collaboratively adapt the intervention with the participants.
|
Control Group
n=12 Participants
Control Group: For participants assigned to the control group, they will be asked to continue with their regular routine for the next two months. Otherwise, the participants in this group will be asked to complete the follow-up baseline questionnaires at 6 and 10 weeks post-baseline. They will be contacted by a physical activity counsellor at the end of the 10-week period.
|
|---|---|---|
|
Life Satisfaction Questionnaire
Baseline
|
4.41 score on a scale
Standard Deviation 0.76
|
4.31 score on a scale
Standard Deviation 0.92
|
|
Life Satisfaction Questionnaire
6 weeks
|
4.42 score on a scale
Standard Deviation 0.75
|
4.17 score on a scale
Standard Deviation 0.95
|
|
Life Satisfaction Questionnaire
10 weeks
|
4.64 score on a scale
Standard Deviation 0.70
|
4.23 score on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Baseline, Week 6, and Week 10Measures symptoms of depression using 9 items. Participants will be asked, "Over the past 4 weeks, how often have you been bothered by any of the following problems?" and rate each symptom (eg, little interest or pleasure in doing things, poor appetite or overeating) on a 4-point scale (0=not at all; 1=Several days; 2=More than half the days 3=nearly every day). A mean score of the items will be computed with higher scores indicating higher reported symptoms of depression.
Outcome measures
| Measure |
Physical Activity Intervention Group
n=10 Participants
Physical Activity Intervention: The PA intervention will be delivered in a virtual face-to-face format using the secure and confidential "Remote Education, Augmented Communication, Training and Supervision" online video-based software. Intervention participants will receive 8 PA sessions over 2 months (1/week), following collaborator specific telephone-based PA counselling protocol. The counsellor will individually tailor her approach to each participant by understanding the participant's past and current PA experiences, motives to be physically active, salient concerns and barriers regarding PA, and physical home environment. Throughout the intervention, the PA counsellor and participants will co-construct and collaboratively adapt the intervention with the participants.
|
Control Group
n=12 Participants
Control Group: For participants assigned to the control group, they will be asked to continue with their regular routine for the next two months. Otherwise, the participants in this group will be asked to complete the follow-up baseline questionnaires at 6 and 10 weeks post-baseline. They will be contacted by a physical activity counsellor at the end of the 10-week period.
|
|---|---|---|
|
Patient Health Questionnaire
Baseline
|
0.50 score on a scale
Standard Deviation 0.44
|
0.56 score on a scale
Standard Deviation 0.62
|
|
Patient Health Questionnaire
6 weeks
|
0.56 score on a scale
Standard Deviation 0.41
|
0.68 score on a scale
Standard Deviation 0.66
|
|
Patient Health Questionnaire
10 weeks
|
0.63 score on a scale
Standard Deviation 0.44
|
0.56 score on a scale
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: Baseline, Week 6, and Week 10Measures self-determination theory perspective on need support. Participants will respond to six items (e.g., "My exercise counselor listened to how I would like to do things regarding my exercise") on a 7-point Likert scale ranging from strongly disagree (1) to strongly agree (7). A higher mean score indicates greater perceptions of need support.
Outcome measures
| Measure |
Physical Activity Intervention Group
n=10 Participants
Physical Activity Intervention: The PA intervention will be delivered in a virtual face-to-face format using the secure and confidential "Remote Education, Augmented Communication, Training and Supervision" online video-based software. Intervention participants will receive 8 PA sessions over 2 months (1/week), following collaborator specific telephone-based PA counselling protocol. The counsellor will individually tailor her approach to each participant by understanding the participant's past and current PA experiences, motives to be physically active, salient concerns and barriers regarding PA, and physical home environment. Throughout the intervention, the PA counsellor and participants will co-construct and collaboratively adapt the intervention with the participants.
|
Control Group
Control Group: For participants assigned to the control group, they will be asked to continue with their regular routine for the next two months. Otherwise, the participants in this group will be asked to complete the follow-up baseline questionnaires at 6 and 10 weeks post-baseline. They will be contacted by a physical activity counsellor at the end of the 10-week period.
|
|---|---|---|
|
Health Care Climate Questionnaire
Baseline
|
6.55 score on a scale
Standard Deviation .43
|
—
|
|
Health Care Climate Questionnaire
Week 6
|
6.67 score on a scale
Standard Deviation .49
|
—
|
|
Health Care Climate Questionnaire
Week 10
|
4.13 score on a scale
Standard Deviation .49
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 6, and Week 10A measure of affective experience capturing broader aspects of well-being/quality of life
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 6, and Week 10Measures meaningful life experience capturing broader aspects of well-being/quality of life. This 5-item scale asks participants to rate their responses from 1 (absolutely untrue) to 7 (absolutely true). A higher score indicated greater reported meaning.
Outcome measures
| Measure |
Physical Activity Intervention Group
n=10 Participants
Physical Activity Intervention: The PA intervention will be delivered in a virtual face-to-face format using the secure and confidential "Remote Education, Augmented Communication, Training and Supervision" online video-based software. Intervention participants will receive 8 PA sessions over 2 months (1/week), following collaborator specific telephone-based PA counselling protocol. The counsellor will individually tailor her approach to each participant by understanding the participant's past and current PA experiences, motives to be physically active, salient concerns and barriers regarding PA, and physical home environment. Throughout the intervention, the PA counsellor and participants will co-construct and collaboratively adapt the intervention with the participants.
|
Control Group
n=12 Participants
Control Group: For participants assigned to the control group, they will be asked to continue with their regular routine for the next two months. Otherwise, the participants in this group will be asked to complete the follow-up baseline questionnaires at 6 and 10 weeks post-baseline. They will be contacted by a physical activity counsellor at the end of the 10-week period.
|
|---|---|---|
|
Meaning Questionnaire
Baseline
|
5.40 score on a scale
Standard Deviation 1.53
|
5.11 score on a scale
Standard Deviation 1.42
|
|
Meaning Questionnaire
6 weeks
|
5.30 score on a scale
Standard Deviation 0.87
|
5.02 score on a scale
Standard Deviation 1.08
|
|
Meaning Questionnaire
10 weeks
|
5.50 score on a scale
Standard Deviation 0.95
|
4.78 score on a scale
Standard Deviation 1.03
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 6, and Week 10This measure consists of a battery of short questionnaires assessing psychosocial predictors of leisure time exercise activity such as self-efficacy, intentions, and action planning among adults with spinal cord injury. Intentions were measured with 2 items and participants responded on a scale (1-strongly disagree 7-strongly agree). Action planning was measured with 4 items and participants responded on a scale (1-definitely false 7-definitely true). Barrier self efficacy was measured with 6 items and task efficacy was measured with 8 items and participants responded on a scale (1-not at all confident 7-completely confident). A higher score on each of the questionnaires indicated higher levels (e.g., greater intentions, self-efficacy, and action planning).
Outcome measures
| Measure |
Physical Activity Intervention Group
n=10 Participants
Physical Activity Intervention: The PA intervention will be delivered in a virtual face-to-face format using the secure and confidential "Remote Education, Augmented Communication, Training and Supervision" online video-based software. Intervention participants will receive 8 PA sessions over 2 months (1/week), following collaborator specific telephone-based PA counselling protocol. The counsellor will individually tailor her approach to each participant by understanding the participant's past and current PA experiences, motives to be physically active, salient concerns and barriers regarding PA, and physical home environment. Throughout the intervention, the PA counsellor and participants will co-construct and collaboratively adapt the intervention with the participants.
|
Control Group
n=12 Participants
Control Group: For participants assigned to the control group, they will be asked to continue with their regular routine for the next two months. Otherwise, the participants in this group will be asked to complete the follow-up baseline questionnaires at 6 and 10 weeks post-baseline. They will be contacted by a physical activity counsellor at the end of the 10-week period.
|
|---|---|---|
|
Social Cognitive Predictors of Leisure Time Physical Activity (LTPA) Among Adults With Spinal Cord Injury (e.g., Self-efficacy, Intentions, Action Planning)
Intentions (baseline)
|
4.70 score on a scale
Standard Deviation 2.20
|
4.58 score on a scale
Standard Deviation 1.96
|
|
Social Cognitive Predictors of Leisure Time Physical Activity (LTPA) Among Adults With Spinal Cord Injury (e.g., Self-efficacy, Intentions, Action Planning)
Intentions (6 weeks)
|
5.50 score on a scale
Standard Deviation 1.16
|
4.66 score on a scale
Standard Deviation 1.84
|
|
Social Cognitive Predictors of Leisure Time Physical Activity (LTPA) Among Adults With Spinal Cord Injury (e.g., Self-efficacy, Intentions, Action Planning)
Intentions (10 weeks)
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5.05 score on a scale
Standard Deviation 2.43
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4.33 score on a scale
Standard Deviation 1.37
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Social Cognitive Predictors of Leisure Time Physical Activity (LTPA) Among Adults With Spinal Cord Injury (e.g., Self-efficacy, Intentions, Action Planning)
Barrier self-efficacy (baseline)
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5.42 score on a scale
Standard Deviation 1.36
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4.65 score on a scale
Standard Deviation 1.57
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Social Cognitive Predictors of Leisure Time Physical Activity (LTPA) Among Adults With Spinal Cord Injury (e.g., Self-efficacy, Intentions, Action Planning)
Barrier self-efficacy (6 weeks)
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5.00 score on a scale
Standard Deviation 1.60
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3.98 score on a scale
Standard Deviation 1.41
|
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Social Cognitive Predictors of Leisure Time Physical Activity (LTPA) Among Adults With Spinal Cord Injury (e.g., Self-efficacy, Intentions, Action Planning)
Barrier self-efficacy (10 weeks)
|
5.17 score on a scale
Standard Deviation 1.14
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3.94 score on a scale
Standard Deviation 1.20
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Social Cognitive Predictors of Leisure Time Physical Activity (LTPA) Among Adults With Spinal Cord Injury (e.g., Self-efficacy, Intentions, Action Planning)
Action planning (baseline)
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5.40 score on a scale
Standard Deviation 1.36
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4.48 score on a scale
Standard Deviation 1.62
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Social Cognitive Predictors of Leisure Time Physical Activity (LTPA) Among Adults With Spinal Cord Injury (e.g., Self-efficacy, Intentions, Action Planning)
Action planning (6 weeks)
|
5.54 score on a scale
Standard Deviation 1.81
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4.02 score on a scale
Standard Deviation 2.16
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Social Cognitive Predictors of Leisure Time Physical Activity (LTPA) Among Adults With Spinal Cord Injury (e.g., Self-efficacy, Intentions, Action Planning)
Action planning (10 weeks)
|
5.45 score on a scale
Standard Deviation 1.31
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4.10 score on a scale
Standard Deviation 2.07
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 6, and Week 10Measure to assess changes in all 6 motivational regulations as per self-determination theory asking reasons why individuals engage in exercise/physical activity during the intervention. Participants will respond to 23 items (e.g, "I don't see why I should have to exercise"), on a 5-point Likert scale ranging from 0 (not true for me) to 4 (very true for me), covering the types of motivational regulations on the self-determination continuum. The mean score of participants' autonomous and controlled motivation will be calculated. A higher mean score indicated a higher level of that type of motivation. Outcome measure data are not presented because of missingness.
Outcome measures
Outcome data not reported
Adverse Events
Physical Activity Intervention Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place