Exercise Program to Improve Balance in Hemophilic Patients
2020년 1월 10일 업데이트: 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
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (예상)
25
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Valencia, 스페인, 46010
- University of Valencia
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
남성
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Control group
Usual daily activities
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Usual daily activities
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change of postural balance: amplitude of Center of Pressure (CoP) displacements
기간: 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
기간: baseline and 3 months
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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
기간: baseline and 3 months
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Sway area of CoP displacements will be assessed in mm^2 using a computerized balance system.
Higher sway area indicate worse balance.
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baseline and 3 months
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Change of dual task balance: amplitude of Center of Pressure (CoP) displacements
기간: baseline and 3 months
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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.
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baseline and 3 months
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Change of dual task balance: velocity of Center of Pressure (CoP) displacements
기간: baseline and 3 months
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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.
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baseline and 3 months
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Change of dual task balance: sway area of Center of Pressure (CoP) displacements
기간: baseline and 3 months
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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.
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baseline and 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Limits of Stability (LOS): success rate
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Felipe Querol-Fuentes, MD, PhD, University of Valencia
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2020년 1월 10일
기본 완료 (예상)
2020년 6월 1일
연구 완료 (예상)
2020년 10월 1일
연구 등록 날짜
최초 제출
2019년 7월 24일
QC 기준을 충족하는 최초 제출
2019년 10월 8일
처음 게시됨 (실제)
2019년 10월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 1월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 1월 10일
마지막으로 확인됨
2020년 1월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- H20190326180948
개별 참가자 데이터(IPD) 계획
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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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