Brief Title
Therapeutic Exercise in Patients With Hemophilia
Official Title
Therapeutic Exercise: Does it Improve Pain Perception, Range of Movement and Quality of Life in Patients With Hemophilia
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
Study Type
Interventional
Primary Outcome
Pressure pain threshold (PPT) in the evaluated muscles.
Condition
Hemophilia
Intervention
Therapeutic exercise
Study Arms / Comparison Groups
Therapeutic exercise
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
45
Start Date
April 1, 2021
Completion Date
February 15, 2022
Primary Completion Date
November 14, 2021
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.
Gender
Male
Ages
30 Years - 45 Years
Accepts Healthy Volunteers
No
Contacts
Alberto M Heredia-Rizo, PhD, +34628603064, [email protected]
Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT04114448
Organization ID
HemoFisio2020
Responsible Party
Principal Investigator
Study Sponsor
University of Seville
Study Sponsor
Alberto M Heredia-Rizo, PhD, Principal Investigator, Physiotherapy Department, University of Sevilla, Spain
Verification Date
April 2021