Exercise for pain management in haemophilia

Not Applicable

• Conditions: Chronic pain in people with severe haemophilia; Haematological Disorders; Hereditary factor VIII deficiency, Hereditary factor IX deficiency

• Registration Number: ISRCTN17454597
• Lead Sponsor: Royal Free London NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-09
• Last Update Posted: 31 October 2022
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

1. People with severe haemophilia A or B (with or without an inhibitor)
2. Aged 18 years and over
3. Self-reported symptoms of chronic pain associated with haemophilic arthropathy (any joint)
4. Willing and able to give informed consent for participation in this study
5. Able to follow instructions
6. Have a good command of written and spoken English
7. Registered at a UK located haemophilia comprehensive care centre with a named physiotherapist
8. Have access to a laptop/tablet at home and sufficient internet connection

Exclusion Criteria

1. Mild or moderate haemophilia A or B
2. Any other inherited bleeding disorder
3. A diagnosis of chronic pain that is not associated with haemophilic arthropathy
4. Severe and/or unstable cardiovascular disease
5. Severe and/or unstable pulmonary disease
6. Uncontrolled diabetes mellitus

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The feasibility aspects of the intervention will be evaluated as follows:<br> 1. Recruitment rate (% uptake)<br> 2. Adherence rate to the intervention procedures<br> 3. Acceptability of the intervention<br> 4. Attrition due to the intervention<br> 5. Safety of the intervention<br> 6. Loss to follow up<br> All will be evaluated from data from screening/recruitment logs, attendance records, participant diaries, participant interviews and review of any recorded adverse events at the end of the study intervention<br>

Secondary Outcome Measures

Name	Time	Method
<br> Measured at baseline, week 6 and week 18:<br> 1. Severity and impact of pain measured using the Brief Pain Inventory (BPI)<br> 2. Confidence to be active even with pain measured using the Pain Self Efficacy Questionnaire (PSEQ)<br> 3. Health-related quality of life measured using the EQ 5D 5L questionnaire<br> 4. Pain and quality of life with arthritic joint pain measured using the Musculoskeletal Health Questionnaire (MSK-HQ)<br> 5. Impact of haemophilia on perceived physical function measured using the Haemophilia Activities List (HAL)<br> 6. Self-reporting functional goals for rehabilitation measured using the Patient-Specific Functional Scale (PSFS)<br> 7. Rating change in one's own clinical status measured by Patient Global Impression of Change (PGIC)<br>