Effectiveness of an Adapted Physical Activity Program for Subjects Suffering From Haemophilia
NCT Number: NCT06580340
Acronym: EMO-AFA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hemophilia|Sports Physical Therapy
Interventions: OTHER: AFA (Adapted Physical Activity)
Sponsor: Istituto Ortopedico Rizzoli
Collaborators: University of Bologna
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-10
Completion Date: 2025-12
Locations: Istituto Ortopedico Rizzoli, Bologna, Bo, 40130, Italy

Summary:
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).

Primary Outcome Measures: 6 Minutes Walking Test, 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: Functional Independence Score in Hemophilia (FISH), 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), 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), 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), 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, 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), 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 ), Pain measured by VAS (Visual Analogue Scale) on target joint, baseline,3 months,6 months|Muscle strenght- 30" Chair stand test, 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, 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, Measure the muscle strenght of hip and knee flexors/extensors by using a Hand held, baseline,3 months,6 months