Therapeutic Exercise in Patients With Hemophilia

Hemophilia Clinical Trial

— Hemofisio  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04114448
• Other study ID #: HemoFisio2020
• Status: Terminated
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: May 2022
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemophilia
• Hemophilia A

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	University of Sevilla	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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