ProACTIVE SCI Physical Activity Intervention

NCT ID: NCT03111030

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-28
• Study Completion Date: 2018-08-01

Brief 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.

Detailed 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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

ProacTive SCI

Individualized physical activity coaching sessions

Group Type: EXPERIMENTAL

ProacTive SCI

Intervention Type: BEHAVIORAL

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rick Hansen Institute

OTHER

Sponsor Role: collaborator

Ontario Neurotrauma Foundation

OTHER

Sponsor Role: collaborator

International Collaboration on Repair Discoveries

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Martin Ginis

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen Martin Ginis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia- Okanagan

Locations

University of British Columbia Okanagan

Kelowna, British Columbia, Canada

International Collaboration on Repair Discoveries

Vancouver, British Columbia, Canada

Countries

Canada

References

Hoekstra F, Martin Ginis KA, Collins D, Dinwoodie M, Ma JK, Gaudet S, Rakiecki D; SCI Exercise Counselling Panel; Gainforth HL. Applying state space grids methods to characterize counsellor-client interactions in a physical activity behavioural intervention for adults with disabilities. Psychol Sport Exerc. 2023 Mar;65:102350. doi: 10.1016/j.psychsport.2022.102350. Epub 2022 Dec 9.

Reference Type: DERIVED

PMID: 37665832 (View on PubMed)

Dinwoodie M, Hoekstra F, Stelzer S, Ma JK, Martin Ginis KA. A dynamic analysis of physical activity barriers experienced by adults with spinal cord injury. Spinal Cord Ser Cases. 2022 Mar 29;8(1):37. doi: 10.1038/s41394-022-00504-y.

Reference Type: DERIVED

PMID: 35351871 (View on PubMed)

Hoekstra F, Collins D, Dinwoodie M, Ma JK, Martin Ginis KA. Measuring behavior change technique delivery and receipt in physical activity behavioral interventions. Rehabil Psychol. 2022 May;67(2):128-138. doi: 10.1037/rep0000440. Epub 2022 Mar 17.

Reference Type: DERIVED

PMID: 35298203 (View on PubMed)

Ma JK, West CR, Martin Ginis KA. The Effects of a Patient and Provider Co-Developed, Behavioral Physical Activity Intervention on Physical Activity, Psychosocial Predictors, and Fitness in Individuals with Spinal Cord Injury: A Randomized Controlled Trial. Sports Med. 2019 Jul;49(7):1117-1131. doi: 10.1007/s40279-019-01118-5.

Reference Type: DERIVED

PMID: 31119717 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H17-00559

Identifier Type: -

Identifier Source: org_study_id