Therapeutic Exercise in Patients With Hemophilia

Not Applicable

Terminated

• Conditions: Hemophilia

• Registration Number: NCT04114448
• Lead Sponsor: University of Seville

Brief Summary

Objectives: To assess the efficacy of performing a therapeutic exercise program, compared with usual care, on pain relief, range of movement and self-perceived quality of life in patients with hemophilia

Design: Quantitative, experimental, longitudinal and prospective study.

Subjects: Male patients between 30 and 45 years old, with hemophilia type A or B and with knee, ankle or elbow arthropathy caused by hemophilia. Participants may be undergoing a pharmacologic treatment with intravenous VIII and/or IX factor

Methods: Participants in the experimental group will an intervention based on therapeutic exercise. One therapist will instruct the patients during two sessions (each lasting approximately 1 hour). Participants will be asked to continue this program at least twice a week. Meanwhile, those in the control group will receive usual physical therapy care, based on a more passive approach, including self-assisted joint mobilization and muscle stretching. Those in the control group will be also instructed to perform the protocol at home, at least twice a week. The intervention protocol in both groups will last three months

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-10-02
• Study First Posted: 2019-10-03
• Study Start: 2021-04-01
• Status Verified: 2022-05
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 5

Inclusion Criteria

• Clinical diagnosis of hemophilia type A or hemophilia type B.
• Knee, elbow or ankle arthropathy caused by hemophilia
• Pharmacological treatment based on using VIII or IX factor concentrates.

Exclusion Criteria

• Presence of VIII FIX inhibitors.
• Having received anti-inflammatory treatment using Arcoxia (Etoricoxib)
• Having undergone a surgical intervention at the target joint.
• Patients enrolled in other research which implies doing physical exercise.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pressure pain threshold (PPT) in the evaluated muscles.	Change from baseline to 3 months after intervention	The PPT levels will be evaluated in KPa. PPT levels, defined as the minimum necessary pressure to evoke pain will be evaluated using a handheld electronic pressure algometer.
Daily life activities	Change from baseline to 3 months after intervention	Ordinary daily life activities will be assessed using the Haemophilia Activities List, which measures the self-perceived functional state.
Self-perceived quality of life: A36 Haemophilia-QoL test	Change from baseline to 3 months after intervention	Quality of life will be evaluated using the A36 Haemophilia-QoL test. This is a valid and specific tool for hemophiliac adults.
Self-reported pain intensity: Numeric Pain Rating Scale (NPRS)	Change from baseline to 3 months after intervention	Self-reported pain will be evaluated using the Numeric Pain Rating Scale (NPRS), where 0 denotes no pain at all, and 10 denotes the maximum possible pain.
General flexibility	Change from baseline to 3 months after intervention	General flexibility will be assessed using the improved tot-flex test, which makes possible to extrapolate general flexibility from a combined movement measure.
Range of movement (ROM).	Change from baseline to 3 months after intervention	Active ROM of the affected joint will be evaluated using inertial sensors, that measure lineal acceleration and angular velocity.

Trial Locations

Locations (1)

University of Sevilla; 🇪🇸 Sevilla, Spain