NCT04408287

Brief Summary

During the current COVID-19 pandemic many spinal cord injury (SCI) rehabilitation services are limited to emergency management, leaving those living in the community without access to services. Unfortunately, this can lead to negative effects including increase in emotional distress, feelings of isolation, and decreased activity engagement. Due to their limited mobility and greater likelihood of respiratory illness it is imperative to provide alternative forms of activity engagement to reduce their risk for secondary complications. Physical activity has been demonstrate to have numerous benefits for individuals with SCI ranging from enhanced health through prevention of secondary complications to improved subjective well-being. The current study proposes to provide an online physical activity program through web-based videoconferencing to person with SCI to improve overall wellbeing and activity engagement. The program will consist of six weeks of twice-weekly, 45-minute sessions in which an experienced fitness instructor (i.e., wheelchair aerobics) with lived experience and a Kinesiology graduate student will lead online sessions. The sessions will be comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down phase that will incorporate upper-extremity flexibility exercises and guided meditation. In all cases, remote (i.e., in-home) participant monitoring of physiological signals will be conducted by the instructor to ensure safety of participants. Once the program has been completed, participants will be asked to complete self-report questionnaires related to acceptability, feasibility, and limited effectiveness. Participants will also be asked to complete a brief semi-structured interview examining barriers and facilitators of the program. Participant feedback from the interviews will be used to further develop of the program to meet the needs of the population and develop sustainable approaches for access to care in the community setting through collaborations with community partners (SCI Ontario, National SCI Alliance, Ontario Neurotrauma Foundation). Ultimately, the proposed project aims to improve overall wellbeing and access to health care service for those with SCI during the COVID-19 quarantine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

September 15, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2022

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

2.3 years

First QC Date

May 20, 2020

Last Update Submit

March 14, 2024

Conditions

Keywords

spinal cord injuryspinal cord injuries

Outcome Measures

Primary Outcomes (1)

  • Treatment Satisfaction

    Treatment Satisfaction Questionnaire

    6 weeks

Secondary Outcomes (7)

  • Ability to Participate in Social Roles and Activities

    Baseline, 6 weeks, and at 3 month follow-up

  • Fatigue

    Baseline, 6 weeks, and at 3 month follow-up

  • Satisfaction with Social Roles and Activities

    Baseline, 6 weeks, and at 3 month follow-up

  • Positive Affect and Well-Being

    Baseline, 6 weeks, and at 3 month follow-up

  • Pain Interference

    Baseline, 6 weeks, and at 3 month follow-up

  • +2 more secondary outcomes

Other Outcomes (1)

  • Fear of COVID-19 Scale

    Baseline, 6 weeks, and at 3 month follow-up

Study Arms (1)

Intervention

EXPERIMENTAL

The program will be delivered twice-weekly through 45-minute sessions over 6 weeks. An experienced fitness instructor with lived experience and a graduate student from the Department of Health and Rehabilitation Sciences, will lead a class of 4-6 participants. The sessions will be comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down phase that will incorporate upper-extremity flexibility exercises and mindfulness meditation. Over the duration the instructor will be sensitive to varying levels of function and fitness and will structure the classes to enable a slow progression of intensity. Individual semi-structured interviews will be completed over the WebEx platform to garner feedback and improve study programming for future implementation of a health care service at Parkwood Institute Outpatient Clinic.

Other: WebEx Physical Activity Program

Interventions

The program will be delivered twice-weekly through 45-minute sessions over 6 weeks. An experienced fitness instructor with lived experience and a graduate student from the Department of Health and Rehabilitation Sciences, will lead a class of 4-6 participants. The sessions will be comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down phase that will incorporate upper-extremity flexibility exercises and mindfulness meditation. Over the duration the instructor will be sensitive to varying levels of function and fitness and will structure the classes to enable a slow progression of intensity. Individual semi-structured interviews will be completed over the WebEx platform to garner feedback and improve study programming for future implementation of a health care service at Parkwood Institute Outpatient Clinic.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult 18 years or older; living with a spinal cord injury; living in the community in Ontario; access to a computer and internet

You may not qualify if:

  • Not cleared by a physician to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Josephs Parkwood Institute

London, Ontario, N6C 5J1, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Swati Mehta, PhD

    London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    PRINCIPAL INVESTIGATOR
  • Eldon Loh, PhD

    Parkwood Institute, St. Joseph's Health Care London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The proposed study will deliver an online physical activity program to persons with SCI across Ontario through the WebEx platform at Parkwood Institute. Participants will be recruited from across Ontario through SCI rehabilitation centers and established service providers. Strategic advertising through community partners such as Spinal Cord Injury Ontario, Canadian SCI Alliance and Ontario Neurotrauma Foundation will also be conducted. Study participants will include those with a spinal cord injury that have completed rehabilitation and are living in the community. Participants must have some upper limb function permitting arm movement against gravity. All participants must have physician clearance to participate in the study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2020

First Posted

May 29, 2020

Study Start

September 15, 2020

Primary Completion

December 28, 2022

Study Completion

December 31, 2022

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations