Clinical trial NCT06580340: Effectiveness of an Adapted Physical Activity Program for Subjects Suffering From Haemophilia
Official title: Effectiveness of an Adapted Physical Activity Program for Subjects Suffering From Haemophilia:a Prospective Interventional Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemophilia
Sports Physical Therapy
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
Collaborators: name: University of Bologna
First posted: 2024-08-30
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).


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)
* Significant neurological conditions that impair motor or cognitive function

Primary outcomes:
measure: 6 Minutes Walking Test
timeFrame: baseline,3 months,6 months
Secondary outcomes:
measure: Functional Independence Score in Hemophilia (FISH)
timeFrame: baseline,3 months,6 months
measure: Hemophilia joint health score (HJHS)
timeFrame: baseline,3 months,6 months
measure: Tampa Scale of Kinesiophobia - (TSK)
timeFrame: baseline,3 months,6 months
measure: Hemophilia Activity List (HAL)
timeFrame: baseline,3 months,6 months
measure: Balance - Single leg stand test
timeFrame: baseline,3 months,6 months
measure: Balance - Time Up and Go (TUG)
timeFrame: baseline,3 months,6 months
measure: Pain (VAS - Visual Analogue Scale )
timeFrame: baseline,3 months,6 months
measure: Muscle strenght- 30" Chair stand test
timeFrame: baseline,3 months,6 months
measure: Muscle strenght-Arm curl test
timeFrame: baseline,3 months,6 months
measure: Muscle strenght- Hand held measuring of hip and knee flexors/extensors
timeFrame: baseline,3 months,6 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: Bo
Study officials:
References:
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