Therapeutic Exercise in Patients With Hemophilia

NCT ID: NCT04114448

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-04-01

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

Conditions

Hemophilia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Therapeutic exercise

Intervention Type: OTHER

Patients will perform an exercise protocol specifically designed for patients with hemophilia that will include exercises focused on improving range of movement, strength, flexibility, balance and coordination as well as diaphragmatic breathing at the start and at the beginning of each session.

Usual 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.

Group Type: ACTIVE_COMPARATOR

Usual physical therapy care

Intervention Type: OTHER

Patients will undergo usual physical therapy treatment for hemophiliacs, based on affected self and gentle joint mobilization and stretching of muscles involved in the affected joints.

Interventions

Therapeutic exercise

Patients will perform an exercise protocol specifically designed for patients with hemophilia that will include exercises focused on improving range of movement, strength, flexibility, balance and coordination as well as diaphragmatic breathing at the start and at the beginning of each session.

Intervention Type: OTHER

Usual physical therapy care

Patients will undergo usual physical therapy treatment for hemophiliacs, based on affected self and gentle joint mobilization and stretching of muscles involved in the affected joints.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Seville

OTHER

Sponsor Role: lead

Responsible Party

Alberto Marcos Heredia-Rizo

Assistant Professor. Physiotherapy Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alberto M Heredia-Rizo, PhD

Role: PRINCIPAL_INVESTIGATOR

Physiotherapy Department, University of Sevilla, Spain

Locations

University of Sevilla

Seville, , Spain

Countries

Spain

Other Identifiers

HemoFisio2020

Identifier Type: -

Identifier Source: org_study_id