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Therapeutic Exercise in Patients With Hemophilia (Hemofisio)

Primary Purpose

Hemophilia

Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Therapeutic exercise
Usual physical therapy care
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilia focused on measuring Hemophilia, Therapeutic exercise, Physical therapy, Randomized controlled trial, Pain perception, Range of movement

Eligibility Criteria

30 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Sevilla

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Therapeutic exercise

Usual care

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Range of movement (ROM).
Active ROM of the affected joint will be evaluated using inertial sensors, that measure lineal acceleration and angular velocity.
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.
Daily life activities
Ordinary daily life activities will be assessed using the Haemophilia Activities List, which measures the self-perceived functional state.
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.

Secondary Outcome Measures

Full Information

First Posted
September 27, 2019
Last Updated
May 8, 2023
Sponsor
University of Seville
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1. Study Identification

Unique Protocol Identification Number
NCT04114448
Brief Title
Therapeutic Exercise in Patients With Hemophilia
Acronym
Hemofisio
Official Title
Therapeutic Exercise: Does it Improve Pain Perception, Range of Movement and Quality of Life in Patients With Hemophilia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
The Study was terminated due to lack of funding for continuing
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia
Keywords
Hemophilia, Therapeutic exercise, Physical therapy, Randomized controlled trial, Pain perception, Range of movement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto M Heredia-Rizo, PhD
Organizational Affiliation
Physiotherapy Department, University of Sevilla, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sevilla
City
Sevilla
ZIP/Postal Code
41009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Therapeutic Exercise in Patients With Hemophilia

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