Pilot Study of a Sedentary Behaviour Intervention for Individuals With a Spinal Cord Injury

NCT06957483 | Active Not Recruiting

• 1 other identifier: 50038-NHS-Mar/2025-54084-2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals with spinal cord injury have a greater risk of heart disease and stroke than non-disabled individuals. This might be partly because wheelchair users engage in high amounts of sedentary behaviour. A review found a lack of programmes aimed at reducing sedentary behaviour in individuals with paraplegia. This means we do not know how good these programmes are for reducing heart disease risk markers. A programme to support reductions in sedentary behaviour has been co-designed with individuals with paraplegia, healthcare professionals, and people who support individuals with paraplegia in the community. This study aims to evaluate the new programme to determine its acceptability, fidelity, safety and preliminary efficacy. The Reducing sedEntary Activities to improve Cardiovascular Health in individuals with Spinal Cord Injury (REACH -SCI) intervention will last eight weeks and involve (1) a wearable activity tracker to give reminders to break up sedentary behaviour, (2) education around what sedentary behaviour is, how to reduce and break up sedentary behaviour, and the benefits of doing so, (3) a goal setting worksheet related to sedentary behaviour, (4) one-to-one motivational support sessions to help set goals, review progress and give motivation, (5) peer support using a group chat with other participants in a smartphone messaging app , and (6) activity tools (exercise bands and a handcycle) to support breaking up sedentary behaviour throughout the day. Measurements of fatigue, pain, physical activity, sedentary behaviour, heart disease risk markers, wellbeing, anxiety, depression and quality of life will be taken at baseline before the programme starts and then again after the programme ends. Acceptability of the intervention and data collection procedures will be explored using semi-structured interviews and questionnaires.

Conditions

Spinal Cord Injury

Keywords

Cardiovascular disease; Intervention; Paraplegia; Physical activity; Sedentary behaviour; Spinal cord injury

Outcome Measures

Primary Outcomes (5)

• Intervention acceptability

  Following completion of the intervention, acceptability will be assessed via an adapted questionnaire with 5-point Likert scales and individual semi-structured interviews to explore constructs from the Theoretical Framework of Acceptability (TFA). The TFA assesses acceptability in the context of seven components (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy), as well as overall intervention acceptability.

  At intervention end (8 weeks)

• Intervention fidelity

  Intervention fidelity will be assessed using a checklist to record each component being delivered as planned. This will include participants being provided with the wearable activity tracker, educational booklet, goal setting worksheet, exercise bands and portable hand cycle. Fidelity to the educational resource will be evaluated verbally in one-to-one motivational support sessions. Attendance at each motivational support session and duration of these sessions will be recorded. This will be in addition to a checklist for all planned aspects of the sessions being covered by the researcher delivering the intervention sessions.

  From baseline to intervention end (8 weeks)

• Intervention safety - Adverse events

  Safety of the intervention will be evaluated through adverse events (AE) experienced during the study. These will be self-reported at each data collection point, during contact with a facilitator as part of the intervention, and ad-hoc throughout the study by contacting a member of the research team via phone or email.

  From baseline to intervention end (8 weeks)

• Intervention safety - Pain

  Safety will also be evaluated by measuring pain using the McGill Pain Questionnaire (MPQ), which is validated in individuals with SCI. Pain will be rated across 20 domains of pain using rating scales. Overall pain will be scored from 0 to 78, with a higher score representing worse levels of pain.

  Baseline and at intervention end (8 weeks)

• Intervention safety - Fatigue

  Safety will also be evaluated by measuring fatigue using the Modified Fatigue Impact Scale (MFIS), which is validated in individuals with SCI. Fatigue will be rated on a 5-point scale according to 21 domains of fatigue. Overall fatigue will be scored between 0 and 84, with a higher score representing worse levels of fatigue.

  Baseline and at intervention end (8 weeks)

Secondary Outcomes (22)

• Participant engagement

  At intervention end (8 weeks)

• Acceptability of data collection procedures

  At intervention end (8 weeks)

• Study feasibility

  From recruitment to measurements taken at intervention end (8 weeks)

• Sedentary time

  Baseline and in the final week of the intervention period

• Physical activity

  Baseline and in the final week of the intervention period

Study Arms (1)

Intervention

EXPERIMENTAL

All participants will receive the REACH-SCI intervention in this single-arm study. The single arm will involve a wearable activity tracker, educational resources, goal setting, motivational support from a trained researcher, peer support and activity tools. The intervention period will be for eight weeks and will start after completion of all baseline measurements and provision of all intervention materials.

Behavioral: REACH-SCI (Reducing sedEntary Activities to improve Cardiovascular Health in individuals with a Spinal Cord Injury)

Interventions

REACH-SCI (Reducing sedEntary Activities to improve Cardiovascular Health in individuals with a Spinal Cord Injury) BEHAVIORAL

The REACH-SCI intervention was co-designed with key stakeholders and aims to reduce and break up sedentary behaviour in individuals with paraplegia. The intervention will last eight weeks and involve (1) a wearable activity tracker to give reminders to break up sedentary behaviour, (2) education around what sedentary behaviour is, how to reduce and break up sedentary behaviour, and the benefits of doing so, (3) a goal setting worksheet related to sedentary behaviour, (4) one-to-one motivational support sessions to help set goals, review progress and give motivation, (5) peer support using a smartphone app, and (6) activity tools to support breaking up sedentary behaviour throughout the day.

Also known as: REACH-SCI

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with self-reported paraplegia i.e. complete or incomplete SCI at T1 or below. Traumatic, non-traumatic, complete and incomplete SCI will all be eligible.
• At least 18 years of age.
• Self-report using a manual wheelchair as their primary mode of mobility inside and outside of the home.
• Able to travel to Brunel University of London to undertake study measurements.
• Access to use of a smartphone or tablet with internet access.
• Able to communicate in English at a level sufficient to understand the study, complete study measurements and engage fully with the intervention.
• Able to provide informed consent.
• Willing and able to provide fingertip blood samples and fast prior to measurement sessions.
• Able to independently transfer to a treatment couch and lay supine to undertake anthropometric measurements.

You may not qualify if:

• Self-reported heart condition, chest pain, dizziness, bone or joint problem, or any other condition that may be exacerbated by doing physical activity, as indicated via responses to the PAR-Q+.
• Self-reported history of uncontrolled autonomic dysreflexia in the past 12 months.
• Self-reported pregnancy.
• Currently participating in another research project that involves an intervention.

Sponsors & Collaborators

• Brunel University: lead
• Royal National Orthopaedic Hospital NHS Trust: collaborator

Study Sites (1)

Brunel University of London

Uxbridge, London, UB8 3PH, United Kingdom

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Cardiovascular Diseases; Paraplegia; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Daniel Bailey, PhD

  Brunel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader in Sedentary Behaviour and Health

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 4, 2025
• Study Start: May 12, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Shared data will be available at study end following data analysis, after which there will be no time limit to gain access.
• Access Criteria: Shared, anonymised data will be publicly available in an online open research repository.

Locations

GB (1)