Clinical trial NCT06583538: An Online Rehabilitation Programme for People with SCI
Official title: An Online Rehabilitation Programme to Support Physical Activity Adherence and Functional Capacity in People with Spinal Cord Injury Following Discharge Into the Community: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Physical Inactivity
Spinal Cord Injury, Acute
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this feasibility study is to explore the feasibility and effectiveness of a 12-week online rehabilitation programme in people with Spinal Cord Injury during the transition from hospital to home.

The main question\[s\] it aims to answer are:

* What is the feasibility of an online rehabilitation programme to support physical activity adherence in people with spinal cord injury following discharge into the community?
* How effective is an online rehabilitation programme to enhance functional capacity, physical activity and quality of life in people with spinal cord injury following discharge into the community?

Participants will be given a personalised online rehabilitation programme to complete two times a week. It will consist of a warm up two exercise components (cardiorespiratory fitness and muscle strength) and a cool down.

Detailed description: Bridging the gap between the inpatient setting to the home environment is essential to promote Physical Activity (PA) adherence, improve functional independence and enhance quality of life by implementing lifelong exercise habits. To our knowledge, no study has investigated the feasibility of an online rehabilitation programme among sub-acute Spinal Cord Injury (SCI) patients during this important discharge period from hospital to home. Therefore, this study will explore the feasibility and effectiveness of a 12-week online rehabilitation programme in people with SCI during the transition from hospital to home.

All subacute inpatients who are undergoing their first episode of inpatient rehabilitation post SCI at the Queen Elizabeth National Spinal Injuries Unit (QENSIU) who fulfil the inclusion criteria will be invited to take part in the current study. A rehabilitation programme will be prescribed individually for each participant. Each programme will align with the current PA guidelines for adults with SCI and will be tailored to the participants ability. Participants will be advised to complete the programme twice per week. It will consist of 20 mins cardiorespiratory followed by a strengthening session. Therefore, the participants will engage in the programme for roughly 40 minutes twice per week. The participants will be instructed to log all completed sessions in an online diary so adherence and duration of PA can be monitored.

Assessment will consist of 4 phases, two in person assessments at baseline and 6 weeks post discharge and two remote (online) assessments at 2 and 12 weeks post discharge. Each assessment will consist of quantitative outcome measures. Additionally, a subset of the study sample will take part in a qualitative structured video interview at the end of their intervention period.

Eligibility criteria: Inclusion Criteria:

* Inpatient at the Queen Elizabeth National Spinal Injuries Unit
* Incomplete or complete spinal cord injury of less than one year in duration
* Medically stable to engage in physical rehabilitation and physical activity
* Able to engage in manual wheelchair propulsion and / or weight baring activities
* Discharge date anticipated within the next 4 weeks
* Access and capability to use the internet

Exclusion Criteria:

* Under 18 years old
* Chronic spinal cord injury patients more than one year since injury
* Discharge planned to another hospital or care facility
* Co-morbidities which would preclude taking part in a physical activity programme: medically diagnosed ischemic heart disease; unstable angina, dysrhythmia or unstable autonomic dysreflexia; recent osteoporotic fracture, tracheostomy, current pressure injury, current substance dependence, psychosis, severe chronic upper extremity pain, surgery pending within 6 months, recurrent infection or illness requiring hospitalization (Bombardier et al., 2021).
* Those who do not wish to take part in a physical activity research study
* Unable to understand written and spoken English language

Primary outcomes:
measure: Adherence
timeFrame: 12 weeks
measure: Acceptability
timeFrame: Week 6 to week 12
measure: Participant recruitment and retention
timeFrame: 12 weeks
Secondary outcomes:
measure: Self-report Physical Activity Scale for individuals with Physical Disabilities (PASIPD)
timeFrame: Baseline, Week 2, Week 6 and week 12
measure: 6-minute wheelchair test (6minWCT) OR 6-minute walk test (6MinWT)
timeFrame: Baseline and week 6
measure: Muscle Strength in kg
timeFrame: Baseline and week 6
measure: Borg Rate of Perceived Exertion (RPE) Scale
timeFrame: Baseline and week 6
measure: Walking Index for Spinal Cord Injury (WISCI II)
timeFrame: Baseline and week 6
measure: Spinal Cord Independence Measure Self Report (SCIM III SR)
timeFrame: Baseline, Week 2, Week 6 and week 12
measure: World Health Organisation Quality of Life-Bref Scale (WHOQoL-Bref)
timeFrame: Baseline, Week 2, Week 6 and week 12
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth National Spinal Injuries Unit
state: Scotland
Study officials:
affiliation: Glasgow Caledonian University
name: Elaine Coulter, PhD
role: STUDY_CHAIR
References: