Therapeutic Exercise in Patients With Hemophilia

Not Applicable

Terminated

• Conditions: Hemophilia
• Interventions: Other: Usual physical therapy care; Other: Therapeutic exercise

• 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

Arm && Interventions

Group	Intervention	Description
Usual care	Usual physical therapy care	Patients will be instructed to perform an usual care physical therapy intervention protocol. Participants in this group will be told to undergo gentle self-performed joint mobilization and stretching exercises. Each initial contact session will last approximately 1 hour. After baseline, participants will be instructed to undergo at least two sessions per week during 3 consecutive months.
Therapeutic exercise	Therapeutic exercise	Patients will be trained to perform a therapeutic exercise intervention protocol. The program will be based on active physical activity including strength, balance an coordination exercises, among others. Each initial contact session will last approximately 1 hour. After baseline, participants will be instructed to undergo at least two sessions per week during 3 consecutive months.

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