Reducing sedentary behaviour after stroke

Not Applicable

• Conditions: Stroke; Circulatory System; Stroke, not specified as haemorrhage or infarction

• Registration Number: ISRCTN82280581
• Lead Sponsor: Bradford Teaching Hospitals NHS Foundation Trust

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37518078/ (added 31/07/2023) 2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37699629/ protocol for the process evaluation (added 14/09/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Last Update Posted: 2 September 2024
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Current participant inclusion criteria as of 25/04/2023:
All stroke survivors with the following characteristics are eligible for this trial:
1. Are aged 16 years or over at the time of stroke
2. New or recurrent clinically diagnosed ischaemic or haemorrhagic (excluding subarachnoid haemorrhage) stroke
3. Require manual contact of no more than one person to stand to prevent falling. Manual contact consists of continuous or intermittent light touch to assist balance or coordination (i.e. not to support body weight)
4. Planned discharge to live in the community (not to a care home)
5. Provide written informed consent or Consultee agreement

Thus, the study will include a range of abilities from people who need help with balance/coordination to stand to those able to walk independently anywhere.

Family/friends /carer will be eligible for the study provided they are:
1. Aged 16 years or over
2. A family member/close friend/carer of a stroke survivor participating in the study and identified by the stroke survivor as someone they engage with on a regular basis (meet at least once a fortnight)
3. Able and willing to provide written informed consent

Previous participant inclusion criteria:
All stroke survivors with the following characteristics are eligible for this trial:
1. New or recurrent clinically diagnosed ischaemic or haemorrhagic (excluding subarachnoid haemorrhage) stroke
2. Requires manual contact of no more than one person to stand to prevent falling. Manual contact consists of continuous or intermittent light touch to assist balance or coordination in keeping with Functional Ambulatory Categories [Holden et al, 1984] (FAC) 3-6
3. Planned discharge to live in the community (not to a care home)
4. Provide written informed consent or Consultee agreement

Thus, the study will include a range of abilities from people who need help with balance/coordination to walk (FAC score=3) to those able to walk independently anywhere (FAC score=6)

Family/friends /carer will be eligible for the study provided they are:
1. Aged 16 years or over
2. A family member/close friend/carer of a stroke survivor participating in the study and identified by the stroke survivor as someone they engage with on a regular basis (meet at least once a fortnight)
3. Able and willing to provide written informed consent

Exclusion Criteria

Current participant exclusion criteria as of 25/04/2023:
Stroke survivors will be excluded from the trial if they:
1. Are in receipt of palliative care
2. Are discharged outside the defined geographical area supported by the associated community service(s) participating in the trial Family members/friends/carers will be excluded from the trial if the person with stroke does not consent to the trial

Previous participant exclusion criteria:
Stroke survivors will be excluded from the trial if they:
1. Are in receipt of palliative care
2. Have an FAC score of 1 (unable to stand without the help of a hoist or two people) or an FAC score of 2 (need continuous support to walk), as they will be unable to amend their behaviour without substantial help
3. Are discharged outside the area supported by the associated community service(s) participating in the trial

Family members/friends/carers will be excluded from the trial if the person with stroke does not consent to the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 25/04/2023:<br>Participant-reported physical and social independence measured using the Nottingham Extended Activities of Daily Living scale (NEADL) at 12 months post-registration<br><br><br><br>Previous primary outcome measure:<br>Physical and social independence measured using the Nottingham Extended Activities of Daily Living (NEADL) at baseline, 6, 12 and 24 months