Effectiveness of an Adapted Physical Activity Program for Subjects Suffering From Haemophilia (EMO-AFA)

May 25, 2026 updated by: Istituto Ortopedico Rizzoli

Effectiveness of an Adapted Physical Activity Program for Subjects Suffering From Haemophilia:a Prospective Interventional Study

The present study aims to evaluate the modification of functional capacity induced by an adapted physical activity program in subjects with haemophilia.

The exercise program used aims to improve joint mobility, muscle strength, static and dynamic balance, motor coordination.

The program is structured in 1 hour sessions of 2 days/week and lasts 6 months.

The primary endpoint is the change in functional capacity calculated as the difference between the baseline assessment and the 3 and 6 month assessment of the 6 Minutes Walking Test measured with the G-Walk (BTS Bioengineering S.p.A).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Bo
      • Bologna, Bo, Italy, 40130
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of hemophilia A or B;
  • Signature of informed consent;
  • Availability of a medical certificate for non-competitive activities

Exclusion Criteria:

  • Active bleeding
  • Severe joint deformities that prevent exercise
  • Insufficiency of communicative and/or sensory functions so severe that it is impossible to understand or carry out the trainer's instructions (dementia, aphasia, blindness, deafness)
  • Heart failure (NYHA class > 2)
  • Unstable angina
  • Lung disease requiring oxygen therapy
  • Symptomatic peripheral arterial disease
  • Myocardial infarction or hospitalization within the previous 6 months
  • Symptomatic orthostatic hypotension
  • Hypertension in poor pharmacological control (diastolic> 95 mmHg, systolic> 160 mmHg)
  • Significant neurological conditions that impair motor or cognitive function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients
patients with emophilia receiving a program of adapted physical activity
Other: AFA (Adapted Physical Activity)
An exercise program to improve joint mobility, muscle strength, static and dynamic balance, motor coordination will be performed 2 times/week for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 Minutes Walking Test
Time Frame: baseline,3 months,6 months
The change in functional capacity calculated as the difference between the baseline 6 Minutes Walking Test assessment and the 3 and 6 month assessment measured with the G-Walk (BTS Bioengineering S.p.A).
baseline,3 months,6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Independence Score in Hemophilia (FISH)
Time Frame: baseline,3 months,6 months
It is a questionnaire which is carried out by an operator to evaluate autonomy in carrying out eight activities of daily life: personal hygiene, eating, dressing, transferring from chairs, squatting, walking, climbing stairs, running. Each activity is measured according to the amount of assistance needed to perform it.
baseline,3 months,6 months
Hemophilia joint health score (HJHS)
Time Frame: baseline,3 months,6 months
It is a scale compiled by an operator to evaluate the health status of the joints. The HJHS measures joint health in the domains of body structure and function (biomechanics) of the structures most frequently affected by hemorrhage in patients with hemophilia: the knees, ankles, and elbows.
baseline,3 months,6 months
Tampa Scale of Kinesiophobia - (TSK)
Time Frame: baseline,3 months,6 months
It is a questionnaire filled in by the patient to assess fear of movement. This scale is an international evaluation parameter with which a persistent and constant, completely unjustified concern in carrying out movements for fear of causing pain or damage is highlighted.
baseline,3 months,6 months
Hemophilia Activity List (HAL)
Time Frame: baseline,3 months,6 months
It is a questionnaire filled in by the patient on activity limitations. The HAL scale measures the impact of haemophilia on functional abilities in adults. It is made up of 42 questions investigating 7 domains: 1. Lying / Sitting / Kneeling / Standing, 2. Leg functions, 3. Arm functions, 4. Transport, 5. Personal care, 6. Household activities, 7. Leisure and sporting activities.
baseline,3 months,6 months
Balance - Single leg stand test
Time Frame: baseline,3 months,6 months
The test should be performed with eyes open and hands on the hips. Instruct the patient to stand on one leg unassisted, starting when the patient's foot leaves the ground and stopping the time the patient's foot touches the ground and/or when their hands leave the hips. Abnormal values may indicate conditions such as peripheral neuropathy, intermittent claudication, or other conditions that may impair balance
baseline,3 months,6 months
Balance - Time Up and Go (TUG)
Time Frame: baseline,3 months,6 months
The TUG is a general physical performance test used to assess mobility, balance and locomotor performance in people with potential balance disturbances. More specifically, it assesses the ability to perform sequential motor tasks relative to walking and turning.
baseline,3 months,6 months
Pain (VAS - Visual Analogue Scale )
Time Frame: baseline,3 months,6 months
Pain measured by VAS (Visual Analogue Scale) on target joint
baseline,3 months,6 months
Muscle strenght- 30" Chair stand test
Time Frame: baseline,3 months,6 months
The purpose of this test in to evaluate leg strength and endurance, by counting the number of times the patient comes to a full standing position in 30 seconds
baseline,3 months,6 months
Muscle strenght-Arm curl test
Time Frame: baseline,3 months,6 months
this test evaluates functional upper extremity fitness of adults, with the goal is to complete as many curls (through the entire available range of motion) in 30 seconds
baseline,3 months,6 months
Muscle strenght- Hand held measuring of hip and knee flexors/extensors
Time Frame: baseline,3 months,6 months
Measure the muscle strenght of hip and knee flexors/extensors by using a Hand held
baseline,3 months,6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Collaborators

University of Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2024

Primary Completion (Actual)

October 27, 2025

Study Completion (Actual)

October 27, 2025

Study Registration Dates

First Submitted

August 23, 2024

First Submitted That Met QC Criteria

August 28, 2024

First Posted (Actual)

August 30, 2024

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMO- AFA

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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