ProACTIVE SCI Physical Activity Intervention

Spinal Cord Injuries Clinical Trial

Official title:

ProACTIVE SCI Physical Activity Coaching Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111030
• Other study ID #: H17-00559
• Status: Completed
• Phase: N/A
• Start date: April 28, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: January 2022
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will employ a randomized, wait-list controlled trial. A total of 30 participants (15 experimental, 15 wait-list control) between 18-65 years of age who have chronic SCI ≥ 1 year prior will be recruited. Physical activity measures will be taken using wrist-based accelerometers and the Leisure Time Physical Activity Questionnaire for people with SCI (LTPAQ). Psychosocial factors will be evaluated through questionnaires. The primary health outcome measure (aPWV), and secondary cardiovascular parameters will be assessed using a combination of echocardiography and ultrasound. Fitness will be determined using a peak oxygen consumption test on an arm-cycle ergometer. All measurement will be taken at baseline and after 9 weeks following intervention commencement. Physical activity will also be sampled mid-intervention at 4 and 7 weeks. Training will involve weekly, 10-15 minute coaching sessions for 9 weeks. All pre- and post-assessments will take place at the Blusson Spinal Cord Centre at ICORD. Intervention content will be delivered in-person, over Skype or phone, and the wrist- worn accelerometers will be delivered and picked up from the participant's home during the intervention.

Description:

A randomized, wait-list controlled trial will be used to compare the effects of tailored PA coaching sessions versus no coaching on PA behaviour, psychosocial factors, and health outcomes. Eligible individuals will be randomly assigned (1:1) to either the experimental (PA coaching sessions) or wait-list control condition. Matched randomization based on baseline physical activity levels will be used. The randomization sequence will be generated by a research assistant independent of the trial.

Day 1 testing measures include vascular measures (arterial pulse wave velocity, arterial structure; 30 minutes), cardiac structure and function measures (30 minutes), a peak oxygen uptake test (60 minutes), for a total duration of 2 hours. Participants will be given an accelerometer to wear for the 6-day monitoring period (6.1.2) after which they will return for Day 2 testing.

Day 2 testing measures include administration of the LTPAQ (5 minutes), administration of the demographics and Health Action Process Approach model questionnaire (25 minutes), and a measurement of energy expenditure at different sub-maximal wheeling speeds to calibrate MVPA cut-points (30 minutes) and at baseline, the first PA coaching session will be administered (60 minutes) whereas at post-test a semi-structured interview will be administered (60 minutes). Total duration of day 2 testing will be 2 hours. The intervention protocol is described below. During the intervention, physical activity will be sampled at two time points; accelerometer and PARA SCI data will be taken during week 4 and week 7.

INTERVENTION

Intervention Protocol:

Experimental participants will receive weekly PA coaching sessions. Each session will be 10-15 minutes in duration and delivered either face to face, over Skype, or when the former modes are unavailable, over the phone. Additionally, supplemental resources may be emailed to the participants based on need throughout the intervention.

Participants' motivation to exercise will first be determined according to stages of the HAPA model. Those who identify as pre-intenders (no intention to exercise) will receive intervention strategies that focus on changing motivation to be physically active. Those identified as intenders (willing to exercise but have not started) will focus on providing resources and behavioural strategies to commence physical activity. Lastly, those identified as actors (already exercising) will receive intervention strategies that help participants maintain or improve PA behaviour.

For those in the intender or actor stage, the intervention aims to promote the international SCI PA guidelines to promote fitness (at least 20 minutes of moderate vigorous aerobic activity twice/week and strength training twice/week). For those exceeding the fitness guidelines, the international SCI PA guidelines to promote health are promoted (at least 30 minutes of moderate to vigorous aerobic activity three times/week and strength training twice/week). However, these aims will be modified based on the individual's baseline PA. During the first visit, participants' baseline PA levels will be reviewed and an appropriate PA goal to achieve in the following month will be formed. Ultimately, the goal is the decision of the participant.

Following goal setting, barriers to participating in PA will be identified. The interventionist will select intervention strategies based on the identified barriers. A pre-formed chart of corresponding intervention strategies (e.g. use of behaviour change techniques, referral to facilities or peers, suggesting at-home exercises) was developed to aid this pairing process (Appendix A). These intervention strategies are accompanied by a comprehensive toolkit based from the HAPA model (Appendix B). In brief, the toolkit advises on three key strategies for promoting PA to people with SCI: i) education, ii) referral, iii) tailored PA prescription.

Remaining weekly coaching sessions will review participants' progress and barriers to discuss new goals and strategies as outlined above.

Control Participants:

Control participants will complete baseline and post-testing only. Following completion of post-test measures they will be administered the same PA coaching session as the intervention group, with post-test measures being repeated upon intervention completion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Individuals must be competent to give informed consent,

• be able to propel an arm ergometer.

Exclusion Criteria:

• History and/or symptoms of CVD or cardiopulmonary problems/disease.

• Major trauma or surgery within the last 6 months.

• Active Stage 3 or 4 pressure ulcer (based on the National Pressure Ulcer Advisory Panel classification)

• Recent (within 1 year) history of lower-extremity or non-union fracture

• Any unstable medical/psychiatric condition or substance abuse disorder that is likely to affect their ability to complete this study.

• Individuals with active medical issues such as pressure sores, urinary tract infections, hypertension, or heart disorders.

• Any cognitive dysfunction or language barrier that would prevent subjects from following English instructions.

• Subjects may be excluded at the discretion of the principal investigator due to other, unforeseen, safety issues.

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Behavioral:
• 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: An assessment of motivated the participant is to be physically active 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. Progress and barriers will be reassessed and discussed.

Locations

Country	Name	City	State
Canada	University of British Columbia Okanagan	Kelowna	British Columbia
Canada	International Collaboration on Repair Discoveries	Vancouver	British Columbia

Sponsors (4)

Lead Sponsor	Collaborator
University of British Columbia	International Collaboration on Repair Discoveries, Ontario Neurotrauma Foundation, Rick Hansen Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Physical Activity: Leisure Time Physical Activity Questionnaire for People With SCI (LTPAQ)	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.	Baseline, week 4, week 7, week 10, 6 month follow up
Primary	Change in Total Accelerometer Count as a Measure of Change in Physical Activity: 6-day Physical Activity Monitoring Period	Participants 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.	Baseline, week 4, week 7, week 10
Secondary	Change in Health Action Process Approach Model Measure	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.	Baseline, 9 weeks from intervention start (week 10)
Secondary	Number of Participants Participating in Qualitative Interviews	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.	9 weeks from intervention start (week 10)
Secondary	Change in Pulse Wave Velocity	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).	Baseline, 9 weeks from intervention start (week 10)
Secondary	Change in Arterial Structure: Wall Thickness	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.	Baseline, 9 weeks from intervention start (week 10)
Secondary	Change in End Systolic Volume	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.	Baseline, 9 weeks from intervention start (week 10)
Secondary	Change in End Diastolic Volume	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.	Baseline, 9 weeks from intervention start (week 10)
Secondary	Change in Intraventricular Septum Diameter	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.	Baseline, 9 weeks from intervention start (week 10)
Secondary	Change in Ventricular Internal Diameter	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.	Baseline, 9 weeks from intervention start (week 10)
Secondary	Change in Systolic Function	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.	Baseline, 9 weeks from intervention start (week 10)
Secondary	Change in Ejection Fraction	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.	Baseline, 9 weeks from intervention start (week 10)
Secondary	Change in Cardiac Output	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.	Baseline, 9 weeks from intervention start (week 10)
Secondary	Change in Fractional Shortening	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.	Baseline, 9 weeks from intervention start (week 10)
Secondary	Change in Diastolic Function	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.	Baseline, 9 weeks from intervention start (week 10)
Secondary	Aerobic Fitness Evaluation: Peak Oxygen Uptake Test (VO2peak)	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	Baseline, 9 weeks from intervention start (week 10)