ProACTIVE SCI Physical Activity Intervention

NCT03111030 | Completed Results

• 1 other identifier: H17-00559
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (14)

• Change in Health Action Process Approach Model Measure

  Baseline, 9 weeks from intervention start (week 10)

• Number of Participants Participating in Qualitative Interviews

  9 weeks from intervention start (week 10)

• Change in Pulse Wave Velocity

  Baseline, 9 weeks from intervention start (week 10)

• Change in Arterial Structure: Wall Thickness

  Baseline, 9 weeks from intervention start (week 10)

• Change in End Systolic Volume

  Baseline, 9 weeks from intervention start (week 10)

Study Arms (2)

ProacTive SCI

EXPERIMENTAL

Individualized physical activity coaching sessions

Behavioral: ProacTive SCI

Wait-list control

NO INTERVENTION

Standard care, receiving physical activity coaching sessions after completing post-testing

Interventions

ProacTive SCI 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.

ProacTive SCI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Participants may self- identify as male, female, other
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals must be competent to give informed consent,
• be able to propel an arm ergometer.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Rick Hansen Institute: collaborator
• Ontario Neurotrauma Foundation: collaborator
• International Collaboration on Repair Discoveries: collaborator

Study Sites (2)

University of British Columbia Okanagan

Kelowna, British Columbia, V1V 1V7, Canada

Location

International Collaboration on Repair Discoveries

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (4)

• 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.

  PMID: 37665832 DERIVED

• 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.

  PMID: 35351871 DERIVED

• 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.

  PMID: 35298203 DERIVED

• 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.

  PMID: 31119717 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Dr. Kathleen Martin Ginis
• Organization: Unviersity of British Columbia

Kathleen_martin.ginis@ubc.ca

250-807-9768

Study Officials

• Kathleen Martin Ginis, PhD

  University of British Columbia- Okanagan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: April 12, 2017
• Study Start: April 28, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: December 5, 2024
• Results First Posted: March 9, 2022

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)