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Exercise Program to Improve Balance in Hemophilic Patients

10 de enero de 2020 actualizado por: Felipe Querol Fuentes, University of Valencia

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

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

25

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • España
      • Valencia, España, 46010
        • University of Valencia

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 60 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Masculino

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Control group
Usual daily activities
Otro: Normal daily activities
Usual daily activities
Experimental: Training group
Each subject will participate in 2 sessions each week during 3 months.
Otro: Progressive balance training
Progressive balance training program

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change of postural balance: amplitude of Center of Pressure (CoP) displacements
Periodo de tiempo: baseline and 3 months
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
Periodo de tiempo: baseline and 3 months
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
Periodo de tiempo: baseline and 3 months
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
Periodo de tiempo: baseline and 3 months
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
Periodo de tiempo: baseline and 3 months
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
Periodo de tiempo: baseline and 3 months
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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Limits of Stability (LOS): success rate
Periodo de tiempo: baseline and 3 months
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
Periodo de tiempo: baseline and 3 months
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
Periodo de tiempo: baseline and 3 months
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
Periodo de tiempo: baseline and 3 months
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
Periodo de tiempo: baseline and 3 months
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
Periodo de tiempo: baseline and 3 months
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)
Periodo de tiempo: baseline and 3 months

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)
Periodo de tiempo: baseline and 3 months

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
Periodo de tiempo: baseline and 3 months
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
Periodo de tiempo: baseline and 3 months
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)
Periodo de tiempo: baseline and 3 months
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
Periodo de tiempo: baseline
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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Valencia

Investigadores

  • Investigador principal: Felipe Querol-Fuentes, MD, PhD, University of Valencia

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

10 de enero de 2020

Finalización primaria (Anticipado)

1 de junio de 2020

Finalización del estudio (Anticipado)

1 de octubre de 2020

Fechas de registro del estudio

Enviado por primera vez

24 de julio de 2019

Primero enviado que cumplió con los criterios de control de calidad

8 de octubre de 2019

Publicado por primera vez (Actual)

10 de octubre de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de enero de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

10 de enero de 2020

Última verificación

1 de enero de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • H20190326180948

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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