- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07629063
Effectiveness of Resistance Exercises Added to Aerobic and Balance Exercises in Parkinson's Disease
The Effects of Resistive Exercises Added to Aerobic and Balance Exercises on Quality of Life, Activities of Daily Living, Cognitive Functions, and Sarcopenia Parameters in Patients With Early-Stage Parkinson's Disease: A Prospective Randomized Controlled Study.
연구 개요
상세 설명
Parkinson's disease (PD) is a neurodegenerative disease characterized by bradykinesia, rigidity, resting tremor and postural instability. It can lead to numerous motor, neuropsychiatric, cognitive, and autonomic symptoms. In advanced stages, it can increase the risk of falling by causing postural instability. Sarcopenia is characterized by a decrease in muscle mass and function. Sarcopenia prevalence increases with age, leading to increased fragility and risk of falling. Studies have shown that various exercise programs, including aerobic, balance, and resistive exercises, have positive effects on rigidity, tremor, gait disorders, and physical capacity in patients diagnosed with PD. The purpose of this study is to evaluate the effects of resistive exercises added to aerobic and balance exercises on quality of life, activities of daily living, cognitive functions, and sarcopenia parameters in patients diagnosed with early-stage PD.
Adults who aged between 40-70 years, diagnosed with PD and meet predefined inclusion and exclusion criteria will be enrolled and randomly assigned to one of two exercise based treatment groups. Both groups will receive aerobic and balance exercises, while one group will additionaly receive resistive exercises. Both groups will undergo exercise programs three days a week for eight weeks. Evaluations will be conducted using the The Parkinson's Disease Questionnaire-39 (PDQ-39), Short Physical Performance Battery (SPPB), SARC-F Questionnaire, Berg Balance Test, Katz Index of Independence in Activities of Daily Living, Montreal Cognitive Assesment (MoCA), Patient Health Questionnaire-9 (PH-9), functional performance tests, grip strentgh measurements and quadriceps muscle thickness measurement via ultrasonography. Evaluations will be performed at baseline, on the first day after the treatment and 4 weeks after the end of the treatment.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Istanbul, 터키 (Türkiye)
- Sisli Hamidiye Etfal Training and Research Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged 40 to 70 years
- Patients diagnosed with Modified Hoehn-Yahr stage 1-3 Parkinson's disease
- Patients diagnosed with Parkinson's disease for more than 1 year
- Patients who can mobilize without an assistive device
Exclusion Criteria:
- Patients diagnosed with Parkinson Plus syndrome
- History of uncontrolled hypertension
- History of uncontrolled diabetes mellitus
- History of serebrovascular disease within the past 6 months
- History of miyocardial infarction within the past 6 months
- History of knee or hip artroplasty surgery
- History of severe cardiac arrythmia
- Presence of cardiac pacemaker
- Presence of severe dementia
- History of severe psychiatric disorders
- Patients who have on dialysis
- Presence of acute infection
- Pregnancy
- History of malignancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Aerobic and Balance Exercise Group
Participants will receive an exercise program with 3 days a week for 8 weeks.
Each treatment session will not exceed 45 minutes.
Program will include aerobic exercises with 15 minutes on a treadmill, aiming not to exceed 85% of maximum heart rate and balance exercises including tandem stance, tandem walk, side stepping, backward walking, single leg stance.
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An 3 days a week for 8 weeks aerobic and balance exercises program
다른 이름들:
A 3 days a week for 8 weeks aerobic, balance and resistive exercises program
다른 이름들:
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실험적: Aerobic, Balance and Resistive Exercise Group
Participants will receive an exercise program with 3 days a week for 8 weeks.
Each treatment session will not exceed 45 minutes.
Program will include aerobic exercises with 15 minutes on a treadmill, aiming not to exceed 85% of maximum heart rate; balance exercises including tandem stance, tandem walk, side stepping, backward walking, single leg stance and resistive exercises for upper and lower extremity
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An 3 days a week for 8 weeks aerobic and balance exercises program
다른 이름들:
A 3 days a week for 8 weeks aerobic, balance and resistive exercises program
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Grip strenght
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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Grip strength is measured using a hydraulic hand dynamometer with the dominant hand.
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Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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Chair Stand Test
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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Chair Stand Test is used to assess muscle function.
Patients asked to sit and stand on a chair for 5 times.
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Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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Gait Speed
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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Gait speed is assessed by measuring the time it takes the patient to walk a distance of 4 meters.
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Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quadriceps Muscle Thickness Measurement
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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Quadriceps muscle thickness measurement is performed ultrasonographically with a linear probe, without compression, with the patient in the supine position, from the anterior side, at the midpoint of the linear line passing between the anterior superior iliac spine (ASIS) and the upper pole of the patella.
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Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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Time-Up And Go Test
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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It is measured by the time it takes for a person to get up from their chair, walk 3 meters, return, and sit back down.
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Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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SARC-F Questionnaire
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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SARC-F is a screening tool to identify propable sarcopenic patients.
The total score ranges from 0 to 10; a score of 4 or higher indicates a risk of sarcopenia.
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Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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The Short Physical Performance Battery (SPPB)
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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The Short Physical Performance Battery (SPPB) is a assessment tool for evaluating physical performance.
The total score ranging from 0 to 12 where 0 indicates worst performance and 12 indicates best performance.
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Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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Berg Balance Scale
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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Berg Balance Scale is a 14-item test used to evaluate functional balance and fall risk in patiens.
Each item is scored on a 0-4 scale.
The total score is ranging 0 to 56 where lower scores indicates higher fall risk.
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Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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The Parkinson's Disease Questionnaire-39 (PDQ-39)
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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The Parkinson's Disease Questionnaire-39 (PDQ-39) is used to assess quality of life among with patients with Parkinson's disease.
The scale consists of 39 multiple-choice items covering 8 factors.
Each question is scored between 0 and 4. Higher scores indicate a deterioration in quality of life.
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Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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The Patient Health Questionnaire (PHQ)
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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The Patient Health Questionnaire-9 (PHQ-9) is diagnostic and screening tool for depression.
The PHQ-9 measures symptoms over the past 2 weeks on a scale of 0 (not at all) to 3 (nearly every day).
Total score ranges 0 to 27.
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Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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Katz Index of Independence in Activities of Daily Living
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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Katz Index of Independence in Activities of Daily Living is used to assess basic functional status and the level of independency.
The total score ranging from 0 to 6, where 0 indicates severe functional impairment and 6 indicates full function.
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Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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The Montreal Cognitive Assessment (MoCA)
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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The Montreal Cognitive Assessment (MoCA) is used to detect cognitive impairment.
The total score ranges 0 to 30 which scores of 26 to 30 are generally considered normal cognitive function.
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Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Vieira de Moraes Filho A, Chaves SN, Martins WR, Tolentino GP, de Cassia Pereira Pinto Homem R, Landim de Farias G, Fischer BL, Oliveira JA, Pereira SKA, Vidal SE, Mota MR, Moreno Lima R, Jaco de Oliveira R. Progressive Resistance Training Improves Bradykinesia, Motor Symptoms and Functional Performance in Patients with Parkinson's Disease. Clin Interv Aging. 2020 Jan 23;15:87-95. doi: 10.2147/CIA.S231359. eCollection 2020.
- Leal LC, Abrahin O, Rodrigues RP, da Silva MC, Araujo AP, de Sousa EC, Pimentel CP, Cortinhas-Alves EA. Low-volume resistance training improves the functional capacity of older individuals with Parkinson's disease. Geriatr Gerontol Int. 2019 Jul;19(7):635-640. doi: 10.1111/ggi.13682. Epub 2019 Apr 29.
- Kim R, Choi S, Kang N, Park K, Shin H, Lee H, Lee H, Jun JS, Jeon B, Byun K. Effects of high-intensity interval training and moderate-intensity continuous training on sarcopenia-related parameters in participants with Parkinson's disease: A 24-week randomized pilot trial substudy. Parkinsonism Relat Disord. 2023 Dec;117:105901. doi: 10.1016/j.parkreldis.2023.105901. Epub 2023 Oct 21.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 3103 / 05.08.2025
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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