Clinical trial NCT04114448: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hemophilia
Keywords: Hemophilia
Therapeutic exercise
Physical therapy
Randomized controlled trial
Pain perception
Range of movement
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 5
Sex: MALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Pressure pain threshold (PPT) in the evaluated muscles.
timeFrame: Change from baseline to 3 months after intervention
measure: Self-reported pain intensity: Numeric Pain Rating Scale (NPRS)
timeFrame: Change from baseline to 3 months after intervention
measure: Range of movement (ROM).
timeFrame: Change from baseline to 3 months after intervention
measure: General flexibility
timeFrame: Change from baseline to 3 months after intervention
measure: Daily life activities
timeFrame: Change from baseline to 3 months after intervention
measure: Self-perceived quality of life: A36 Haemophilia-QoL test
timeFrame: Change from baseline to 3 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: University of Sevilla
Study officials:
affiliation: Physiotherapy Department, University of Sevilla, Spain
name: Alberto M Heredia-Rizo, PhD
role: PRINCIPAL_INVESTIGATOR
References: