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Clinical Trials/NCT06583538
NCT06583538
Completed
N/A

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

Glasgow Caledonian University1 site in 1 country15 target enrollmentNovember 22, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
Glasgow Caledonian University
Enrollment
15
Locations
1
Primary Endpoint
Adherence
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 22, 2023
End Date
October 8, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Adherence

Time Frame: 12 weeks

Adherence will be monitored remotely by the number of online diary entries per participant.á Adherence will then be calculated based on percentage of completed sessions per week over the 12 weeks.Following the guidelines, the optimum number of completed sessions per participant is 2 x 20 mins cardiorespiratory and 2 strengthening per week. \>75% = excellent , 50-75% = good, \<50% = satisfactory, \<25% = low.

Acceptability

Time Frame: Week 6 to week 12

Acceptability will be captured by the structured online video interview. Thematic analysis will be used to assess the qualitative data.

Participant recruitment and retention

Time Frame: 12 weeks

Measured by assessing participant eligibility (number of those approached and those who meet the inclusion criteria), recruitment rate per month and retention of recruited participants.

Secondary Outcomes

  • Self-report Physical Activity Scale for individuals with Physical Disabilities (PASIPD)(Baseline, Week 2, Week 6 and week 12)
  • 6-minute wheelchair test (6minWCT) OR 6-minute walk test (6MinWT)(Baseline and week 6)
  • Muscle Strength in kg(Baseline and week 6)
  • Borg Rate of Perceived Exertion (RPE) Scale(Baseline and week 6)
  • Walking Index for Spinal Cord Injury (WISCI II)(Baseline and week 6)
  • Spinal Cord Independence Measure Self Report (SCIM III SR)(Baseline, Week 2, Week 6 and week 12)
  • World Health Organisation Quality of Life-Bref Scale (WHOQoL-Bref)(Baseline, Week 2, Week 6 and week 12)

Study Sites (1)

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