Trial Outcomes & Findings for ProACTIVE SCI Physical Activity Intervention (NCT NCT03111030)
NCT ID: NCT03111030
Last Updated: 2024-12-05
Results Overview
Participants will be asked to complete a questionnaire, guided by the co-investigator (Jasmin Ma), that asks the participant to recall in the last 7 days how many days and for how long leisure time physical activity was performed. The recall assessment will take approximately 5 minutes to complete.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Baseline, week 4, week 7, week 10, 6 month follow up
Results posted on
2024-12-05
Participant Flow
Participant milestones
| Measure |
ProacTive SCI
Individualized physical activity coaching sessions
ProacTive SCI: Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:
1. An assessment of motivated the participant is to be physically active
2. A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.
B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.
3. Progress and barriers will be reassessed and discussed.
|
Wait-list Control
Standard care, receiving physical activity coaching sessions after completing post-testing
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ProACTIVE SCI Physical Activity Intervention
Baseline characteristics by cohort
| Measure |
ProacTive SCI
n=14 Participants
Individualized physical activity coaching sessions
ProacTive SCI: Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:
1. An assessment of motivated the participant is to be physically active
2. A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.
B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.
3. Progress and barriers will be reassessed and discussed.
|
Wait-list Control
n=14 Participants
Standard care, receiving physical activity coaching sessions after completing post-testing
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.79 years
STANDARD_DEVIATION 13.63 • n=5 Participants
|
45.57 years
STANDARD_DEVIATION 10.49 • n=7 Participants
|
45.68 years
STANDARD_DEVIATION 11.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Leisure Time Physical Activity Questionnaire for People With SCI (LTPAQ)
|
212 Total LTPA min/week
STANDARD_DEVIATION 195 • n=5 Participants
|
274 Total LTPA min/week
STANDARD_DEVIATION 300 • n=7 Participants
|
243 Total LTPA min/week
STANDARD_DEVIATION 248 • n=5 Participants
|
|
Aerobic Fitness Evaluation: Peak Oxygen Uptake Test (VO2peak)
|
1.15 L/min
STANDARD_DEVIATION .36 • n=5 Participants
|
1.13 L/min
STANDARD_DEVIATION .43 • n=7 Participants
|
1.14 L/min
STANDARD_DEVIATION .41 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 4, week 7, week 10, 6 month follow upParticipants will be asked to complete a questionnaire, guided by the co-investigator (Jasmin Ma), that asks the participant to recall in the last 7 days how many days and for how long leisure time physical activity was performed. The recall assessment will take approximately 5 minutes to complete.
Outcome measures
| Measure |
ProacTive SCI
n=14 Participants
Individualized physical activity coaching sessions
ProacTive SCI: Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:
1. An assessment of motivated the participant is to be physically active
2. A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.
B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.
3. Progress and barriers will be reassessed and discussed.
|
Wait-list Control
n=14 Participants
Standard care, receiving physical activity coaching sessions after completing post-testing
|
|---|---|---|
|
Change in Physical Activity: Leisure Time Physical Activity Questionnaire for People With SCI (LTPAQ)
Baseline
|
212 Total LTPA min/week
Standard Deviation 195
|
274 Total LTPA min/week
Standard Deviation 300
|
|
Change in Physical Activity: Leisure Time Physical Activity Questionnaire for People With SCI (LTPAQ)
Week 4
|
393 Total LTPA min/week
Standard Deviation 413
|
NA Total LTPA min/week
Standard Deviation NA
Data only collected in intervention group
|
|
Change in Physical Activity: Leisure Time Physical Activity Questionnaire for People With SCI (LTPAQ)
Week 7
|
370 Total LTPA min/week
Standard Deviation 258
|
NA Total LTPA min/week
Standard Deviation NA
Data only collected in intervention group
|
|
Change in Physical Activity: Leisure Time Physical Activity Questionnaire for People With SCI (LTPAQ)
Week 10
|
405 Total LTPA min/week
Standard Deviation 364
|
147 Total LTPA min/week
Standard Deviation 192
|
|
Change in Physical Activity: Leisure Time Physical Activity Questionnaire for People With SCI (LTPAQ)
6 months FU
|
348 Total LTPA min/week
Standard Deviation 269
|
NA Total LTPA min/week
Standard Deviation NA
Data only collected in intervention group
|
PRIMARY outcome
Timeframe: Baseline, week 4, week 7, week 10Participants will be fitted with a wrist-based tri-axial accelerometer to be worn 24 hours a day for 6 days in order to determine intensity and amount of PA. They will keep a detailed PA diary recording all leisure time PA performed during the day. The primary outcome will be total vector magnitude (VM) accelerometer counts from a tri-axial wrist-worn accelerometer (GT9X, ActiGraph LLC, FL). During the intervention, the accelerometer will be picked up and dropped off to the participant's home to decrease burden. Text or email reminders (i.e. "Please don't forget to wear your accelerometer today") will be used to promote adherence to accelerometer wear.
Outcome measures
| Measure |
ProacTive SCI
n=14 Participants
Individualized physical activity coaching sessions
ProacTive SCI: Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:
1. An assessment of motivated the participant is to be physically active
2. A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.
B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.
3. Progress and barriers will be reassessed and discussed.
|
Wait-list Control
n=14 Participants
Standard care, receiving physical activity coaching sessions after completing post-testing
|
|---|---|---|
|
Change in Total Accelerometer Count as a Measure of Change in Physical Activity: 6-day Physical Activity Monitoring Period
Baseline
|
562000 Accelerometer total VM counts
Standard Deviation 188000
|
848000 Accelerometer total VM counts
Standard Deviation 759000
|
|
Change in Total Accelerometer Count as a Measure of Change in Physical Activity: 6-day Physical Activity Monitoring Period
Week 4
|
593000 Accelerometer total VM counts
Standard Deviation 307000
|
NA Accelerometer total VM counts
Standard Deviation NA
Data only collected in intervention group
|
|
Change in Total Accelerometer Count as a Measure of Change in Physical Activity: 6-day Physical Activity Monitoring Period
Week 7
|
659000 Accelerometer total VM counts
Standard Deviation 338000
|
NA Accelerometer total VM counts
Standard Deviation NA
Data only collected in intervention group
|
|
Change in Total Accelerometer Count as a Measure of Change in Physical Activity: 6-day Physical Activity Monitoring Period
Week 10
|
702000 Accelerometer total VM counts
Standard Deviation 267000
|
598000 Accelerometer total VM counts
Standard Deviation 390000
|
SECONDARY outcome
Timeframe: Baseline, 9 weeks from intervention start (week 10)This survey will examine psychological factors that may affect PA participation. The survey will be recorded either electronically or with pen and paper depending on the respondent's preference. Survey will take approximately 25 minutes to complete, and will assess constructs related to exercise such as perceived risks, self- efficacy, planning, and social support. The demographics questionnaire will also be administered with this measure. All items will be assessed on a 7-point Likert scale ranging from 1 = "strongly disagree" to 7 = "strongly agree". Higher scores indicate a better outcome.
Outcome measures
| Measure |
ProacTive SCI
n=14 Participants
Individualized physical activity coaching sessions
ProacTive SCI: Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:
1. An assessment of motivated the participant is to be physically active
2. A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.
B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.
3. Progress and barriers will be reassessed and discussed.
|
Wait-list Control
n=14 Participants
Standard care, receiving physical activity coaching sessions after completing post-testing
|
|---|---|---|
|
Change in Health Action Process Approach Model Measure
Aerobic exercise task self-efficacy (Baseline)
|
3.4 score on a scale
Standard Deviation 1.9
|
4.1 score on a scale
Standard Deviation 1.7
|
|
Change in Health Action Process Approach Model Measure
Aerobic exercise task self-efficacy (Week 10)
|
4.7 score on a scale
Standard Deviation 1.2
|
3.6 score on a scale
Standard Deviation 1.6
|
|
Change in Health Action Process Approach Model Measure
Risk perceptions (Baseline)
|
2.5 score on a scale
Standard Deviation 1.6
|
2.5 score on a scale
Standard Deviation 1.3
|
|
Change in Health Action Process Approach Model Measure
Risk perceptions (Week 10)
|
2.8 score on a scale
Standard Deviation 1.6
|
2.5 score on a scale
Standard Deviation 1.1
|
|
Change in Health Action Process Approach Model Measure
Strength exercise task self-efficacy (Baseline)
|
3.9 score on a scale
Standard Deviation 1.6
|
3.7 score on a scale
Standard Deviation 1.6
|
|
Change in Health Action Process Approach Model Measure
Affective outcome expectancies (Baseline)
|
5.1 score on a scale
Standard Deviation 1.3
|
5.7 score on a scale
Standard Deviation 0.9
|
|
Change in Health Action Process Approach Model Measure
Affective outcome expectancies (Week 10)
|
5.6 score on a scale
Standard Deviation 1.0
|
5.4 score on a scale
Standard Deviation 1.0
|
|
Change in Health Action Process Approach Model Measure
Instrumental outcome expectancies (Baseline)
|
6.5 score on a scale
Standard Deviation 0.6
|
6.5 score on a scale
Standard Deviation 0.9
|
|
Change in Health Action Process Approach Model Measure
Instrumental outcome expectancies (Week 10)
|
6.8 score on a scale
Standard Deviation 0.3
|
6.3 score on a scale
Standard Deviation 0.8
|
|
Change in Health Action Process Approach Model Measure
Strength exercise task self-efficacy (Week 10)
|
5.6 score on a scale
Standard Deviation 1.2
|
3.2 score on a scale
Standard Deviation 1.8
|
|
Change in Health Action Process Approach Model Measure
Intentions (Baseline)
|
6.1 score on a scale
Standard Deviation 1.1
|
6.5 score on a scale
Standard Deviation 0.7
|
|
Change in Health Action Process Approach Model Measure
Intentions (Week 10)
|
6.8 score on a scale
Standard Deviation 0.4
|
6.3 score on a scale
Standard Deviation 1.2
|
|
Change in Health Action Process Approach Model Measure
Planning self-efficacy (Baseline)
|
5.9 score on a scale
Standard Deviation 0.8
|
6.2 score on a scale
Standard Deviation 1.1
|
|
Change in Health Action Process Approach Model Measure
Planning self-efficacy (Week 10)
|
6.0 score on a scale
Standard Deviation 0.5
|
6.8 score on a scale
Standard Deviation 0.4
|
|
Change in Health Action Process Approach Model Measure
Barrier self-efficacy (Baseline)
|
5.0 score on a scale
Standard Deviation 1.2
|
4.4 score on a scale
Standard Deviation 1.0
|
|
Change in Health Action Process Approach Model Measure
Barrier self-efficacy (Week 10)
|
5.7 score on a scale
Standard Deviation 0.8
|
4.7 score on a scale
Standard Deviation 1.1
|
|
Change in Health Action Process Approach Model Measure
Scheduling self-efficacy (Baseline)
|
4.9 score on a scale
Standard Deviation 1.5
|
5.3 score on a scale
Standard Deviation 1.2
|
|
Change in Health Action Process Approach Model Measure
Scheduling self-efficacy (Week 10)
|
5.7 score on a scale
Standard Deviation 1.3
|
5.5 score on a scale
Standard Deviation 1.1
|
|
Change in Health Action Process Approach Model Measure
Action planning (Baseline)
|
3.7 score on a scale
Standard Deviation 1.9
|
3.8 score on a scale
Standard Deviation 2.0
|
|
Change in Health Action Process Approach Model Measure
Action planning (Week 10)
|
6.8 score on a scale
Standard Deviation 0.4
|
3.6 score on a scale
Standard Deviation 2.3
|
|
Change in Health Action Process Approach Model Measure
Monitoring (Baseline)
|
4.5 score on a scale
Standard Deviation 1.6
|
4.4 score on a scale
Standard Deviation 1.4
|
|
Change in Health Action Process Approach Model Measure
Monitoring (Week 10)
|
6.3 score on a scale
Standard Deviation 0.8
|
4.4 score on a scale
Standard Deviation 1.3
|
|
Change in Health Action Process Approach Model Measure
Coping self-efficacy (Baseline)
|
6.0 score on a scale
Standard Deviation 0.8
|
5.8 score on a scale
Standard Deviation 1.2
|
|
Change in Health Action Process Approach Model Measure
Coping self-efficacy (Week 10)
|
6.3 score on a scale
Standard Deviation 0.7
|
6.3 score on a scale
Standard Deviation 0.7
|
|
Change in Health Action Process Approach Model Measure
Social support (Baseline)
|
2.2 score on a scale
Standard Deviation 1.0
|
2.0 score on a scale
Standard Deviation 0.8
|
|
Change in Health Action Process Approach Model Measure
Social support (Week 10)
|
2.8 score on a scale
Standard Deviation 0.9
|
1.7 score on a scale
Standard Deviation 0.5
|
|
Change in Health Action Process Approach Model Measure
Presence of barriers (Baseline)
|
5.7 score on a scale
Standard Deviation 1.5
|
5.5 score on a scale
Standard Deviation 1.3
|
|
Change in Health Action Process Approach Model Measure
Presence of barriers (Week 10)
|
6.1 score on a scale
Standard Deviation 1.1
|
5.0 score on a scale
Standard Deviation 1.8
|
|
Change in Health Action Process Approach Model Measure
Knowledge (Baseline)
|
5.9 score on a scale
Standard Deviation 1.1
|
5.2 score on a scale
Standard Deviation 1.9
|
|
Change in Health Action Process Approach Model Measure
Knowledge (Week 10)
|
6.7 score on a scale
Standard Deviation 0.4
|
4.4 score on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 9 weeks from intervention start (week 10)A semi-structured interview will be conducted at the end of the intervention to understand what components were and were not effective. Data will not be recorded. This feedback will be used to improve future iterations of the intervention. There is no associated scale with this measurement.
Outcome measures
| Measure |
ProacTive SCI
n=14 Participants
Individualized physical activity coaching sessions
ProacTive SCI: Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:
1. An assessment of motivated the participant is to be physically active
2. A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.
B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.
3. Progress and barriers will be reassessed and discussed.
|
Wait-list Control
n=14 Participants
Standard care, receiving physical activity coaching sessions after completing post-testing
|
|---|---|---|
|
Number of Participants Participating in Qualitative Interviews
|
14 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 9 weeks from intervention start (week 10)aPWV (cm/s) is calculated by dividing the distance between measurement sites, by the pulse transit time. Distance between the carotid and femoral arteries will be measured using measuring tape along the surface of the body, held parallel to the testing table. The pulse transit is determined from the arterial blood pressure waves, which are collected at each arterial site. A pen-like device (model SPT-301; Millar Instruments Inc., Houston, TX) will be applied to the carotid and femoral arterial sites using a light pressure to obtain arterial pressure waves. Heart rate will be recorded using a single-lead (lead I) electrocardiogram (ECG) (model ML 123, ADInstruments Inc., Colorado Springs, CO).
Outcome measures
| Measure |
ProacTive SCI
n=14 Participants
Individualized physical activity coaching sessions
ProacTive SCI: Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:
1. An assessment of motivated the participant is to be physically active
2. A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.
B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.
3. Progress and barriers will be reassessed and discussed.
|
Wait-list Control
n=14 Participants
Standard care, receiving physical activity coaching sessions after completing post-testing
|
|---|---|---|
|
Change in Pulse Wave Velocity
Baseline
|
10.6 cm/s
Standard Deviation 2.9
|
8.0 cm/s
Standard Deviation 2.0
|
|
Change in Pulse Wave Velocity
Week 10
|
9.7 cm/s
Standard Deviation 2.5
|
8.2 cm/s
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline, 9 weeks from intervention start (week 10)Common carotid arterial images will be collected using B-mode ultrasound (INFO) for 10 cardiac cycles. Images will be analyzed using internal ultrasound software to determine lumen diameter and intima-media thickness.
Outcome measures
| Measure |
ProacTive SCI
n=14 Participants
Individualized physical activity coaching sessions
ProacTive SCI: Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:
1. An assessment of motivated the participant is to be physically active
2. A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.
B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.
3. Progress and barriers will be reassessed and discussed.
|
Wait-list Control
n=14 Participants
Standard care, receiving physical activity coaching sessions after completing post-testing
|
|---|---|---|
|
Change in Arterial Structure: Wall Thickness
Baseline
|
0.62 mm
Standard Deviation 0.16
|
0.56 mm
Standard Deviation 0.07
|
|
Change in Arterial Structure: Wall Thickness
Week 10
|
0.61 mm
Standard Deviation 0.15
|
0.56 mm
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Baseline, 9 weeks from intervention start (week 10)Cardiac image will be collected non-invasively using Doppler ultrasound (Vivid q, GE Healthcare, Buckinghamshire, UK). Image will be collected and stored on the ultrasound for offline analysis.
Outcome measures
| Measure |
ProacTive SCI
n=14 Participants
Individualized physical activity coaching sessions
ProacTive SCI: Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:
1. An assessment of motivated the participant is to be physically active
2. A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.
B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.
3. Progress and barriers will be reassessed and discussed.
|
Wait-list Control
n=14 Participants
Standard care, receiving physical activity coaching sessions after completing post-testing
|
|---|---|---|
|
Change in End Systolic Volume
Baseline
|
38 ml
Standard Deviation 9
|
36 ml
Standard Deviation 9
|
|
Change in End Systolic Volume
Week 10
|
38 ml
Standard Deviation 9
|
35 ml
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Baseline, 9 weeks from intervention start (week 10)Cardiac image will be collected non-invasively using Doppler ultrasound (Vivid q, GE Healthcare, Buckinghamshire, UK). Image will be collected and stored on the ultrasound for offline analysis.
Outcome measures
| Measure |
ProacTive SCI
n=14 Participants
Individualized physical activity coaching sessions
ProacTive SCI: Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:
1. An assessment of motivated the participant is to be physically active
2. A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.
B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.
3. Progress and barriers will be reassessed and discussed.
|
Wait-list Control
n=14 Participants
Standard care, receiving physical activity coaching sessions after completing post-testing
|
|---|---|---|
|
Change in End Diastolic Volume
Baseline
|
87 ml
Standard Deviation 18
|
84 ml
Standard Deviation 20
|
|
Change in End Diastolic Volume
Week 10
|
86 ml
Standard Deviation 14
|
82 ml
Standard Deviation 18
|
SECONDARY outcome
Timeframe: Baseline, 9 weeks from intervention start (week 10)Population: This was not measured or reported.
Cardiac image will be collected non-invasively using Doppler ultrasound (Vivid q, GE Healthcare, Buckinghamshire, UK). Image will be collected and stored on the ultrasound for offline analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 9 weeks from intervention start (week 10)Cardiac image will be collected non-invasively using Doppler ultrasound (Vivid q, GE Healthcare, Buckinghamshire, UK). Image will be collected and stored on the ultrasound for offline analysis.
Outcome measures
| Measure |
ProacTive SCI
n=14 Participants
Individualized physical activity coaching sessions
ProacTive SCI: Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:
1. An assessment of motivated the participant is to be physically active
2. A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.
B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.
3. Progress and barriers will be reassessed and discussed.
|
Wait-list Control
n=14 Participants
Standard care, receiving physical activity coaching sessions after completing post-testing
|
|---|---|---|
|
Change in Ventricular Internal Diameter
Baseline
|
42 mm
Standard Deviation 5
|
43 mm
Standard Deviation 10
|
|
Change in Ventricular Internal Diameter
Week 10
|
43 mm
Standard Deviation 4
|
44 mm
Standard Deviation 4
|
SECONDARY outcome
Timeframe: Baseline, 9 weeks from intervention start (week 10)Cardiac image will be collected non-invasively using Doppler ultrasound (Vivid q, GE Healthcare, Buckinghamshire, UK). Image will be collected and stored on the ultrasound for offline analysis. LV stroke volume will be used to measure change in systolic function.
Outcome measures
| Measure |
ProacTive SCI
n=14 Participants
Individualized physical activity coaching sessions
ProacTive SCI: Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:
1. An assessment of motivated the participant is to be physically active
2. A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.
B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.
3. Progress and barriers will be reassessed and discussed.
|
Wait-list Control
n=14 Participants
Standard care, receiving physical activity coaching sessions after completing post-testing
|
|---|---|---|
|
Change in Systolic Function
Baseline
|
49 ml
Standard Deviation 9
|
48 ml
Standard Deviation 11
|
|
Change in Systolic Function
Week 10
|
49 ml
Standard Deviation 6
|
47 ml
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Baseline, 9 weeks from intervention start (week 10)Cardiac image will be collected non-invasively using Doppler ultrasound (Vivid q, GE Healthcare, Buckinghamshire, UK). Image will be collected and stored on the ultrasound for offline analysis.
Outcome measures
| Measure |
ProacTive SCI
n=14 Participants
Individualized physical activity coaching sessions
ProacTive SCI: Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:
1. An assessment of motivated the participant is to be physically active
2. A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.
B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.
3. Progress and barriers will be reassessed and discussed.
|
Wait-list Control
n=14 Participants
Standard care, receiving physical activity coaching sessions after completing post-testing
|
|---|---|---|
|
Change in Ejection Fraction
Baseline
|
57 % of blood ejected per contraction
Standard Deviation 3
|
57 % of blood ejected per contraction
Standard Deviation 3
|
|
Change in Ejection Fraction
Week 10
|
56 % of blood ejected per contraction
Standard Deviation 3
|
58 % of blood ejected per contraction
Standard Deviation 3
|
SECONDARY outcome
Timeframe: Baseline, 9 weeks from intervention start (week 10)Cardiac image will be collected non-invasively using Doppler ultrasound (Vivid q, GE Healthcare, Buckinghamshire, UK). Image will be collected and stored on the ultrasound for offline analysis.
Outcome measures
| Measure |
ProacTive SCI
n=14 Participants
Individualized physical activity coaching sessions
ProacTive SCI: Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:
1. An assessment of motivated the participant is to be physically active
2. A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.
B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.
3. Progress and barriers will be reassessed and discussed.
|
Wait-list Control
n=14 Participants
Standard care, receiving physical activity coaching sessions after completing post-testing
|
|---|---|---|
|
Change in Cardiac Output
Baseline
|
3.22 L/min
Standard Deviation 0.78
|
3.05 L/min
Standard Deviation 0.87
|
|
Change in Cardiac Output
Week 10
|
3.13 L/min
Standard Deviation 0.63
|
3.13 L/min
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: Baseline, 9 weeks from intervention start (week 10)Cardiac image will be collected non-invasively using Doppler ultrasound (Vivid q, GE Healthcare, Buckinghamshire, UK). Image will be collected and stored on the ultrasound for offline analysis. Longitudinal strain will be used to measure change in fractional shortening.
Outcome measures
| Measure |
ProacTive SCI
n=14 Participants
Individualized physical activity coaching sessions
ProacTive SCI: Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:
1. An assessment of motivated the participant is to be physically active
2. A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.
B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.
3. Progress and barriers will be reassessed and discussed.
|
Wait-list Control
n=14 Participants
Standard care, receiving physical activity coaching sessions after completing post-testing
|
|---|---|---|
|
Change in Fractional Shortening
Baseline
|
-19.0 % change from original length
Standard Deviation 2.6
|
-17.5 % change from original length
Standard Deviation 4.3
|
|
Change in Fractional Shortening
Week 10
|
-19.2 % change from original length
Standard Deviation 2.7
|
-18.1 % change from original length
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Baseline, 9 weeks from intervention start (week 10)Cardiac image will be collected non-invasively using Doppler ultrasound (Vivid q, GE Healthcare, Buckinghamshire, UK). Image will be collected and stored on the ultrasound for offline analysis. E'/A' (ratio between early diastolic septal tissue velocity and late diastolic septal tissue velocity) will be used to measure change in diastolic function.
Outcome measures
| Measure |
ProacTive SCI
n=14 Participants
Individualized physical activity coaching sessions
ProacTive SCI: Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:
1. An assessment of motivated the participant is to be physically active
2. A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.
B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.
3. Progress and barriers will be reassessed and discussed.
|
Wait-list Control
n=14 Participants
Standard care, receiving physical activity coaching sessions after completing post-testing
|
|---|---|---|
|
Change in Diastolic Function
Baseline
|
0.99 Ratio
Standard Deviation 0.21
|
1.10 Ratio
Standard Deviation 0.33
|
|
Change in Diastolic Function
Week 10
|
1.02 Ratio
Standard Deviation 0.32
|
1.14 Ratio
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: Baseline, 9 weeks from intervention start (week 10)Participants will perform a graded arm ergometer test on an electronically braked arm ergometer. For participants with tetraplegia who have limited handgrip function, gloves will be used to secure hands to the ergometer handles. Participants will be instructed to maintain a cycling rate of 50 revolutions per minute (rpm) for the duration of the test. After an initial warm-up at 0W, power output will be increased each minute at a rate of 2-5 W/min for participants with tetraplegia, or 10 W/min for participants with paraplegia, until volitional exhaustion (i.e. dropping below 30 rpm). Oxygen consumption will be recorded on a breath-by-breath basis for the duration of the test and reported as rolling 30-second averages sampled at 5-second intervals as per consensus recommendations. All outcome data are reported here: https://doi.org/10.1007/s40279-019-01118-5
Outcome measures
| Measure |
ProacTive SCI
n=14 Participants
Individualized physical activity coaching sessions
ProacTive SCI: Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:
1. An assessment of motivated the participant is to be physically active
2. A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.
B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.
3. Progress and barriers will be reassessed and discussed.
|
Wait-list Control
n=14 Participants
Standard care, receiving physical activity coaching sessions after completing post-testing
|
|---|---|---|
|
Aerobic Fitness Evaluation: Peak Oxygen Uptake Test (VO2peak)
Baseline
|
1.16 L/min
Standard Deviation 0.38
|
1.13 L/min
Standard Deviation 0.46
|
|
Aerobic Fitness Evaluation: Peak Oxygen Uptake Test (VO2peak)
Week 10
|
1.30 L/min
Standard Deviation 0.43
|
1.06 L/min
Standard Deviation 0.40
|
Adverse Events
ProacTive SCI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait-list Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kathleen Martin Ginis
Unviersity of British Columbia
Phone: 250-807-9768
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place