Therapeutic Exercise in Patients With Hemophilia

NCT04114448 | Terminated DMC

• 1 other identifier: HemoFisio2020
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Keywords

Hemophilia; Therapeutic exercise; Physical therapy; Randomized controlled trial; Pain perception; Range of movement

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Therapeutic exercise

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

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

Interventions

Therapeutic exercise 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.

Therapeutic exercise

Usual physical therapy care 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.

Usual care

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

University of Sevilla

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Alberto M Heredia-Rizo, PhD

  Physiotherapy Department, University of Sevilla, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor. Physiotherapy Department

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 3, 2019
• Study Start: April 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: May 10, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)