Exercise Program to Improve Balance in Hemophilic Patients

Effectiveness of an Exercise Program to Improve Balance and Dual Task in Hemophilic Patients. Clinical Trial

This study evaluates the effectiveness of a program of physiotherapy exercises to train the balance and dual task in adults patients with hemophilia

Study Overview

• Status: Unknown
• Conditions: Haemophilia
• Intervention / Treatment: Other: Normal daily activities; Other: Progressive balance training

Detailed Description

The objective of the study is to create an exercise program to improve the static and dynamic balance in hemophilic patient. In addition, the effect of the exercise program on dual task, functionality, proprioception, QoL, risk of falls and the kinesiophobia will be analyzed.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • University of Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Diagnosis of haemophilia A or B
• Willingness to exercise twice a week during the training program and to complete the pre- and post-program evaluations
• Approval by their hematologist to participate in the exercise program
• With hemostatic coverage supervised by your hematologist.
• Age between 18 and 60 years
• Informed consent signed.

Exclusion Criteria:

• Non adherence to instruction on proper exercise technique
• Surgical procedures performed 6 months prior to or during the exercise program
• A major bleeding episode that posed a risk or prevented exercise
• Need for major surgery
• Suffer from dizziness
• Withdrawal of informed consent
• Acquired hemophilia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control group; Usual daily activities	Other: Normal daily activities; Usual daily activities
Experimental: Training group; Each subject will participate in 2 sessions each week during 3 months.	Other: Progressive balance training; Progressive balance training program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of postural balance: amplitude of Center of Pressure (CoP) displacements	Amplitude of CoP displacements will be assessed in millimeters using a computerized balance system. Higher displacements indicate worse balance.	baseline and 3 months
Change of postural balance: velocity of Center of Pressure (CoP) displacements	Velocity of CoP displacements will be assessed in millimeters using a computerized balance system. Higher velocity indicate worse balance.	baseline and 3 months
Change of postural balance: sway area of Center of Pressure (CoP) displacements	Sway area of CoP displacements will be assessed in mm^2 using a computerized balance system. Higher sway area indicate worse balance.	baseline and 3 months
Change of dual task balance: amplitude of Center of Pressure (CoP) displacements	Amplitude of CoP displacements will be assessed in millimeters using a computerized balance system. Patient will perform a cognitive task (e.g. counting) while maintaining balance. Higher displacements indicate worse balance.	baseline and 3 months
Change of dual task balance: velocity of Center of Pressure (CoP) displacements	Velocity of CoP displacements will be assessed in millimeters using a computerized balance system. Patient will perform a cognitive task (e.g. counting) while maintaining balance. Higher velocity indicate worse balance.	baseline and 3 months
Change of dual task balance: sway area of Center of Pressure (CoP) displacements	Sway area of CoP displacements will be assessed in mm^2 using a computerized balance system. Patient will perform a cognitive task (e.g. counting) while maintaining balance. Higher sway area indicate worse balance.	baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Limits of Stability (LOS): success rate	Evaluations will be done by NedSVE/IBV balance platform. Indices: Max Excursions (%), Directional Control (%), Success (%), LOS rate (%) will be recorded during forward, backward, right and left side movements.	baseline and 3 months
Limits of Stability (LOS): time	Evaluations will be done by NedSVE/IBV balance platform. Indices: Reaction Time (s), Confinement Time (s), will be recorded during forward, backward, right and left side movements.	baseline and 3 months
The Berg Balance Scale	Balance will be assessed with the Berg Balance Scale (BBS), a 14-item physical performance measure of static and dynamic balance found to be reliable. Scoring ranges from 0-56, with higher scores indicating better balance. A score of <46 identifies an individual at risk for falls after stroke.	baseline and 3 months
Functional capacity: The Timed "Up & Go" test	Timed "Up & Go" will be used to measure functional capacity. It is a simple test used to assess a person's mobility and requires both static and dynamic balance. Less time to complete the test in seconds implies better outcome.	baseline and 3 months
Functional capacity: Sit-to-stand test	Sit-to-stand test (3 repetitions) will be used to measure functional capacity. Less time to complete the test in seconds implies better outcome.	baseline and 3 months
Functional capacity: 2-minutes walk test	Evaluation of functional capacity during walking by using 2 minutes walk test. More distance covered in 2 minutes implies better outcome.	baseline and 3 months
Haemophilia Activities List (HAL)	The Haemophilia Activities List questionnaire measures the impact of hemophilia on self-perceived functional abilities in adults. It contains 42 multiple choice questions in seven domains: Lying/sitting/kneeling/standing (8 items) Functions of the legs (9 items) Functions of the arms (4 items) Use of transportation (3 items) Self-care (5 items) Household tasks (6 items) Leisure activities and sports (7 items) The most important outcomes are the overall sum score and three component scores relating to upper extremity activities, basic lower extremity activities, and complex lower extremity activities. The score is obtained using a Likert scale with 5 options: always=2, mostly=3, sometimes=4, rarely=5 and never=6 (complemented by the option "impossible=1" for those people who can not perform such activity). Subscales are summed, with a total score from 0- 252 and higher values represent a worse outcome (greater self-perceived difficulty in carrying out the activities).	baseline and 3 months
Functional Independence Scale for Hemophilia (FISH)	Observed activity limitations will be measured with the Functional Independence Scale for Hemophilia (FISH) as part of the Activity Domain. The scale studies 8 activities (eating and grooming, bathing, dressing, chair, squatting, walking, stairs and running), which are classified into the three groups (Self care, Transfers and Locomotion) and their score ranges from 1 - 4 (1 being the highest dependency and 4 being the greatest independence to perform the exercises). Subscales are summed, with a total score from 8-32 and higher values represent a better outcome. The FISH has been validated for use in developing countries. It consists of observed activities of daily living that are scored for quality.	baseline and 3 months
Quality of Life related with health: questionnaire	Measured by a Specific questionnaire for Quality of Life related with health evaluation for adults with haemophilia (A36Haemophilia-QoL), which explores 9 areas. Subscales and score range: Physical health: 0-32; Daily activities: 0-16; Joints: 0-12; Pain: 0-8; Treatment satisfaction: 0-8; Difficulties treatment: 0-16; Emotional functioning: 0-20; Mental health: 0-12; Social activity: 0-20. Subscales are summed, with a total score from 0-144 and higher values represent a better outcome (more Quality of Life perceived).	baseline and 3 months
Kinesiophobia	Kinesiophobia will be evaluated by Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation. Gómez-Pérez, López-Martínez y Ruiz P., 2011). Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).	baseline and 3 months
Modified Falls Efficacy Scale (mFES)	MFES is a 14-item questionnaire related to daily indoor and outdoor physical activities. It is a 10-point visual analog scale of confidence level in completing a particular activity (item) without falling, rated from 0 to 10, where 0 denotes not confident or sure at all, and 10 denotes completely confident or sure. The total score for the 14 items ranges from 0 to 140.	baseline and 3 months
Joint health status	Joint clinical evaluation of elbows, knees and ankles by using The Hemophilia Joint Health Score 2.1 (HJHS). The full score range goes from 0 to 124 points (0-20 points for each of the six joints evaluated, plus 4 points for the overall assessment of gait. 0 means no joint damage, whereas the higher the value, the higher the degree of arthropathy.	baseline

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Principal Investigator: Felipe Querol-Fuentes, MD, PhD, University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 10, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: H20190326180948

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