Therapeutic Exercise in Patients With Hemophilia (Hemofisio)

University of Seville

Status: Terminated

Conditions: Hemophilia

Treatments: Other: Therapeutic exercise; Other: Usual physical therapy care

Study type: Interventional

Funder types: Other

Identifiers

NCT04114448

HemoFisio2020

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: Male

Ages: 30 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups

Therapeutic exercise

Experimental group

Description:

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.

Treatment:

Other: Therapeutic exercise

Usual care

Active Comparator group

Description:

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.

Treatment:

Other: Usual physical therapy care