- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07861009
Functional Outcomes in Patients With Cerebral Infarction After Aquatic Physiotherapy and Aerobic Exercise
Changes in Functional Outcomes in Patients With Cerebral Infarction Following Aquatic Physiotherapy and Aerobic Exercise
The aim of the study was to evaluate changes in functional outcomes in patients with cerebral infarction following aquatic physiotherapy and aerobic exercises during the second stage of rehabilitation.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ieva Žemaitienė
- 전화번호: +37064822184
- 이메일: ieva.zemaitien@lsmu.lt
연구 연락처 백업
- 이름: Kotryna Burneikaitė
- 이메일: kotrburn0213@kmu.lt
연구 장소
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Kaunas, 리투아니아, LT-53483
- LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
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연락하다:
- Ieva Žemaitienė
- 전화번호: +37064822184
- 이메일: kulautuvos.reabilitacijos.ligonine@kaunoklinikos.lt
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Muscle strength of 4-5 points, assessed using manual muscle testing.
- Ability to walk independently or with the use of an assistive device.
- Stable cardiovascular status, based on the results of a physician's examination and the participant's medical history.
- First-ever cerebral infarction.
- Participants aged 45-74 years.
- Mini-Mental State Examination (MMSE) score of 11-30 points, based on the patient's medical records and the assessment performed by psychologists working at Kulautuva Rehabilitation Hospital.
Exclusion Criteria:
- Muscle strength of less than 4 points, assessed using manual muscle testing.
- Inability to walk independently or with the use of an assistive device.
- Unstable cardiovascular status (uncontrolled arterial hypertension, angina --pectoris, cardiac arrhythmias, and other contraindications).
- Recurrent cerebral infarction.
- Participants younger than 45 years or older than 74 years.
- MMSE score below 11 points.
- Comorbidities that limit the ability to safely perform aquatic physiotherapy or aerobic exercises.
- Contraindications to aquatic physiotherapy (open wounds, skin diseases, etc.).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Aquatic physiotherapy
Participants will be randomly assigned in a 1:1 ratio to one of two intervention groups. The first group will receive aquatic physiotherapy for 30 minutes, 3 times per week, in addition to conventional physiotherapy for 60 minutes, 5 times per week. Participants will be allocated to the aquatic physiotherapy group using randomization to minimize selection bias and ensure comparable distribution of participants between the two groups. |
Aquatic physiotherapy will consist of a structured exercise program performed in water under the supervision of a physiotherapist. Each session will last 30 minutes and will be performed 3 times per week. |
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실험적: Aerobic exercises
Participants will be randomly assigned in a 1:1 ratio to one of two intervention groups. The second group will receive aerobic exercise for 30 minutes, 3 times per week, in addition to conventional physiotherapy for 60 minutes, 5 times per week. Participants will be allocated to the aerobic exercise group using randomization to minimize selection bias and ensure comparable distribution of participants between the two groups. |
Aerobic exercise will consist of a continuous 30-minute cyclical aerobic exercise session performed on a stationary bicycle under the supervision of a physiotherapist. The session will be performed 3 times per week. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Thirty-Second Sit-to-Stand Test
기간: Before and after 3 weeks of rehabilitation
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The Thirty-Second Sit-to-Stand Test will be used to assess lower-extremity muscle strength by measuring the number of complete sit-to-stand repetitions performed in thirty seconds. Minimum 0 repetitions, no fixed maximum; higher scores indicate better lower-extremity functional strength. |
Before and after 3 weeks of rehabilitation
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Six-Minute Walk Test
기간: Before and after 3 weeks of rehabilitation
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The Six-Minute Walk Test will be used to assess functional exercise capacity by measuring the distance walked during six minutes. Six-Minute Walk Test: minimum 0 meters, no fixed maximum; greater distances indicate better walking endurance. |
Before and after 3 weeks of rehabilitation
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Ten-Meter Walk Test
기간: Before and after 3 weeks of rehabilitation
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The Ten-Meter Walk Test will be used to assess walking speed by measuring the time required to walk ten meters. Minimum 0 seconds, no fixed maximum; lower completion times indicate better walking performance. |
Before and after 3 weeks of rehabilitation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Barthel Index
기간: Before and after 3 weeks of rehabilitation
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The Barthel Index will be used to assess the patient's independence in activities of daily living. Minimum 0, maximum 100; higher scores indicate greater independence in activities of daily living. |
Before and after 3 weeks of rehabilitation
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Pittsburgh Sleep Quality Index
기간: Before and after 3 weeks of rehabilitation
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The Pittsburgh Sleep Quality Index will be used to assess the patient's sleep quality and sleep disturbances. Minimum 0, maximum 21; higher scores indicate worse sleep quality. |
Before and after 3 weeks of rehabilitation
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Systolic Blood Pressure
기간: Before and after 3 weeks of rehabilitation
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Systolic blood pressure will be measured to assess the cardiovascular response to physical exercise. Measured in millimeters of mercury (mmHg); no fixed minimum or maximum values; higher or lower values are not inherently better or worse, as interpretation depends on the clinical context. |
Before and after 3 weeks of rehabilitation
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Diastolic Blood Pressure
기간: Before and after 3 weeks of rehabilitation
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Diastolic blood pressure will be measured to assess the cardiovascular response to physical exercise. Measured in millimeters of mercury (mmHg); no fixed minimum or maximum values; higher or lower values are not inherently better or worse, as interpretation depends on the clinical context. |
Before and after 3 weeks of rehabilitation
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Heart Rate Measurement
기간: Before and after 3 weeks of rehabilitation
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Heart rate will be measured to assess the cardiovascular response to physical exercise. Heart rate measured in beats per minute (bpm); no fixed minimum or maximum values; higher or lower values are not inherently better or worse, as interpretation depends on the clinical context. |
Before and after 3 weeks of rehabilitation
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- BE-2-65/2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Coded, de-identified individual participant data collected before and after the intervention will be shared, including results of the 6-Minute Walk Test, 10-Meter Walk Test, 30-Second Sit-to-Stand Test, Barthel Index, Sleep Quality Index questionnaire, as well as blood pressure and heart rate measurements.
IPD 공유 기간
6 months after publication of the primary study results.
IPD 공유 액세스 기준
Access to the coded, de-identified individual participant data and supporting information will be provided to qualified researchers upon reasonable request and approval by the study investigators. Access will be granted for scientifically valid research purposes and subject to applicable ethical and data protection requirements. Researchers will be able to access the individual participant data and study protocol. Requests for access should be submitted to the study investigators.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
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미국 FDA 규제 기기 제품 연구
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