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Completed

NCT Number: NCT06580340

Effectiveness of an Adapted Physical Activity Program for Subjects Suffering From Haemophilia

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).

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Key information

Conditions

Hemophilia Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders Sports Physical Therapy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, Bo, 40130, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AFA (Adapted Physical Activity)

Other

An exercise program to improve joint mobility, muscle strength, static and dynamic balance, motor coordination will be performed 2 times/week for 6 months.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. Pain (VAS - Visual Analogue Scale )

    Time frame: baseline,3 months,6 months

    Pain measured by VAS (Visual Analogue Scale) on target joint

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Collaborators

  • University of Bologna

Registry information

Official study title

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

Acronym: EMO-AFA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2024
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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