Therapeutic Exercise in Patients With Hemophilia (Hemofisio)

Therapeutic Exercise: Does it Improve Pain Perception, Range of Movement and Quality of Life in Patients With Hemophilia

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 Overview

• Status: Terminated
• Conditions: Hemophilia
• Intervention / Treatment: Other: Therapeutic exercise; Other: Usual physical therapy care

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jose Manuel Labao-López, MSc; Phone Number: +34628603064; Email: josemanuellabao@gmail.com
• Study Contact Backup: Name: Alberto M Heredia-Rizo, PhD; Phone Number: +34954486507; Email: amheredia@us.es

Study Locations

• Spain
  • Sevilla, Spain, 41009
    • University of Sevilla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure pain threshold (PPT) in the evaluated muscles.	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.	Change from baseline to 3 months after intervention
Self-reported pain intensity: Numeric Pain Rating Scale (NPRS)	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.	Change from baseline to 3 months after intervention
Range of movement (ROM).	Active ROM of the affected joint will be evaluated using inertial sensors, that measure lineal acceleration and angular velocity.	Change from baseline to 3 months after intervention
General flexibility	General flexibility will be assessed using the improved tot-flex test, which makes possible to extrapolate general flexibility from a combined movement measure.	Change from baseline to 3 months after intervention
Daily life activities	Ordinary daily life activities will be assessed using the Haemophilia Activities List, which measures the self-perceived functional state.	Change from baseline to 3 months after intervention
Self-perceived quality of life: A36 Haemophilia-QoL test	Quality of life will be evaluated using the A36 Haemophilia-QoL test. This is a valid and specific tool for hemophiliac adults.	Change from baseline to 3 months after intervention

Collaborators and Investigators

• Sponsor: University of Seville
• Investigators: Principal Investigator: Alberto M Heredia-Rizo, PhD, Physiotherapy Department, University of Sevilla, Spain

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: October 2, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Physical therapy; Hemophilia; Therapeutic exercise; Pain perception; Range of movement
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Hemophilia A
• Other Study ID Numbers: HemoFisio2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No