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Exercise Program to Improve Balance in Hemophilic Patients

2020年1月10日 更新者: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

研究概览

详细说明

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.

研究类型

介入性

注册 (预期的)

25

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Valencia、西班牙、46010
        • University of Valencia

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

不

有资格学习的性别

男性

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Control group
Usual daily activities
Usual daily activities
实验性的:Training group
Each subject will participate in 2 sessions each week during 3 months.
Progressive balance training program

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change of postural balance: amplitude of Center of Pressure (CoP) displacements
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Limits of Stability (LOS): success rate
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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)
大体时间: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)
大体时间: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
大体时间: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
大体时间: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)
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Felipe Querol-Fuentes, MD, PhD、University of Valencia

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年1月10日

初级完成 (预期的)

2020年6月1日

研究完成 (预期的)

2020年10月1日

研究注册日期

首次提交

2019年7月24日

首先提交符合 QC 标准的

2019年10月8日

首次发布 (实际的)

2019年10月10日

研究记录更新

最后更新发布 (实际的)

2020年1月13日

上次提交的符合 QC 标准的更新

2020年1月10日

最后验证

2020年1月1日

更多信息

与本研究相关的术语

其他研究编号

  • H20190326180948

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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