Exercise Program to Improve Balance in Hemophilic Patients
Effectiveness of an Exercise Program to Improve Balance and Dual Task in Hemophilic Patients. Clinical Trial
調査の概要
詳細な説明
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Valencia、スペイン、46010
- University of Valencia
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
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
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
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Usual daily activities
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実験的:Training group
Each subject will participate in 2 sessions each week during 3 months.
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Progressive balance training program
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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
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Amplitude of CoP displacements will be assessed in millimeters using a computerized balance system.
Higher displacements indicate worse balance.
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baseline and 3 months
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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.
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baseline and 3 months
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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
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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.
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baseline and 3 months
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Limits of Stability (LOS): time
時間枠:baseline and 3 months
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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.
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baseline and 3 months
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The Berg Balance Scale
時間枠:baseline and 3 months
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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.
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baseline and 3 months
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Functional capacity: The Timed "Up & Go" test
時間枠:baseline and 3 months
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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.
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baseline and 3 months
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Functional capacity: Sit-to-stand test
時間枠:baseline and 3 months
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Sit-to-stand test (3 repetitions) will be used to measure functional capacity.
Less time to complete the test in seconds implies better outcome.
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baseline and 3 months
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Functional capacity: 2-minutes walk test
時間枠:baseline and 3 months
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Evaluation of functional capacity during walking by using 2 minutes walk test.
More distance covered in 2 minutes implies better outcome.
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baseline and 3 months
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Haemophilia Activities List (HAL)
時間枠:baseline and 3 months
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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
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Functional Independence Scale for Hemophilia (FISH)
時間枠:baseline and 3 months
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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
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Quality of Life related with health: questionnaire
時間枠:baseline and 3 months
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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).
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baseline and 3 months
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Kinesiophobia
時間枠:baseline and 3 months
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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).
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baseline and 3 months
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Modified Falls Efficacy Scale (mFES)
時間枠:baseline and 3 months
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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.
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baseline and 3 months
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Joint health status
時間枠:baseline
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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.
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baseline
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協力者と研究者
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
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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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Normal daily activitiesの臨床試験
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