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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

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (予想される)

25

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Valencia、スペイン、46010
        • University of Valencia

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~60年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:非ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:Control group
Usual daily activities
Usual daily activities
実験的:Training group
Each subject will participate in 2 sessions each week during 3 months.
Progressive balance training program

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change of postural balance: amplitude of Center of Pressure (CoP) displacements
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Limits of Stability (LOS): success rate
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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
時間枠: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)
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Felipe Querol-Fuentes, MD, PhD、University of Valencia

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2020年1月10日

一次修了 (予想される)

2020年6月1日

研究の完了 (予想される)

2020年10月1日

試験登録日

最初に提出

2019年7月24日

QC基準を満たした最初の提出物

2019年10月8日

最初の投稿 (実際)

2019年10月10日

学習記録の更新

投稿された最後の更新 (実際)

2020年1月13日

QC基準を満たした最後の更新が送信されました

2020年1月10日

最終確認日

2020年1月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • H20190326180948

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