Effectiveness of an Adapted Physical Activity Program for Subjects Suffering From Haemophilia:a Prospective Interventional Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hemophilia
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- 6 Minutes Walking Test
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief 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).
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
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
- Functional Independence Score in Hemophilia (FISH)(baseline,3 months,6 months)
- Hemophilia joint health score (HJHS)(baseline,3 months,6 months)
- Tampa Scale of Kinesiophobia - (TSK)(baseline,3 months,6 months)
- Hemophilia Activity List (HAL)(baseline,3 months,6 months)
- Balance - Single leg stand test(baseline,3 months,6 months)
- Balance - Time Up and Go (TUG)(baseline,3 months,6 months)
- Pain (VAS - Visual Analogue Scale )(baseline,3 months,6 months)
- Muscle strenght- 30" Chair stand test(baseline,3 months,6 months)
- Muscle strenght-Arm curl test(baseline,3 months,6 months)
- Muscle strenght- Hand held measuring of hip and knee flexors/extensors(baseline,3 months,6 months)