Post-stroke fatigue Other
Conditions
Interventions
Sixty participants (15 per group) will be randomised in a 1:1:1:1 manner into one of four treatment groups:
Group 1: Participants will be asked to inflate the BP cuff around the arm to "Pressure 1", t
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (>=18 years) with ischaemic or haemorrhagic stroke, at least 12 weeks prior 2. Symptoms of debilitating fatigue for at least 6 weeks (mean FSS > = 4) 3. Capacity to give consent 4. Able to complete study procedures
Exclusion criteria
Exclusion criteria: 1. Participation in another intervention trial 2. Significant peripheral vascular disease, neuropathy, ulceration or lymphadenopathy in the upper limbs 3. Hospitalisation for cardiovascular or cerebrovascular disease within the last 4 weeks (this may act as an ischaemic conditioning stimulus) 4. Known causes of fatigue e.g. obstructive sleep apnoea, depression, active thyroid disease, active cancer, MS, MND and PD 5. Severe aphasia or cognitive impairment that would preclude their understanding of learning to self-deliver the RIC intervention or complete the required outcome measures (e.g. MRI, exercise tests, questionnaires). We will use the Consent Support Tool (CST) to aid this judgement. 6. Pregnant or trying to get pregnant 7. Prior use of RIC For all participants entering the mechanistic sub-study only: 1. Contraindications to Magnetic Resonance Imaging (MRI) (e.g., metal implant) 2. Has previously experienced or is likely to suffer severe anxiety or claustrophobia in relation to MR imaging examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Feasibility of the intervention will be measured via assessment of: 1.1. Safety, measured by evaluating whether there have been any SAEs related to RIC. 1.2b. Acceptability, measured using a Likert scale rating of RIC-related symptoms and qualitative semi-structured interviews at end of treatment. 1.3. Compliance, measured by evaluating whether >80% intended treatment sessions have been completed. 2. Feasibility of the trial will be measured using the assessment of recruitment rates (at least 1.5 participants/month). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fatigue is measured using the fatigue severity scale 7 (FSS-7) questionnaire at baseline, end of treatment, and 6 months post-treatment. 2. Fatigue is also measured and fatigue symptom profiles are characterised using the modified fatigue impact scale (MFIS) questionnaire at baseline, end of treatment, and 6 months post-treatment. 3. Degree of disability and dependence are measured by the modified Rankin scale (mRS) questionnaire at baseline, end of treatment, and 6 months post-treatment. 4. General function and capacity are measured by the Barthel Index (BI) questionnaire at baseline, end of treatment, and 6 months post-treatment. 5. Anxiety severity is measured by the generalised anxiety disorder 7 (GAD-7) questionnaire at baseline, end of treatment, and 6 months post-treatment. 6. General quality of mental health is measured by the patient health questionnaire 9 (PHQ-9) at baseline, end of treatment, and 6 months post-treatment. 7. General quality of life is measured by the EuroQol 5-dimensional (EQ-5D) questionnaire at baseline, end of treatment, and 6 months post-treatment. 8. Stroke-related quality of life is measured by the stroke impact scale (SIS) questionnaire at baseline, end of treatment, and 6 months post-treatment. 9. Fatigue and physical stamina are measured by the 6 minute walk test (6MWT) at baseline and end of treatment. 10. General physical activity measures such as daily step count, sedentary time, distance moved, exercise time, estimated sleep per night are measured by the Google Inspire3 Fitbit provided to the participant throughout the duration of their involvement in the study (baseline to 6 months post-treatment). Mechanistic sub-study secondary outcome measures: 11. Serum inflammatory markers (IL-1beta, IL-6, IL-10, TNFa, heat shock protein, GLP-1) are measured and analysed via exploratory mediation analysis performed on blood taken from participants at baseline and end of treatment. 12. VO2 peak, VAT and VE/VCO2 are measured via cardio | — |
Countries
England, United Kingdom
Contacts
Public ContactAli Ali
Outcome results
None listed