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Effectiveness of Resistance Exercises Added to Aerobic and Balance Exercises in Parkinson's Disease

2026년 6월 1일 업데이트: Nazlı İlgüner, Sisli Hamidiye Etfal Training and Research Hospital

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.

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. The main question it aims to answer is: In patients diagnosed with early-stage Parkinson's disease, do resistive exercises added to aerobic and balance exercises have an effect on quality of life, daily living activities, cognitive function, and sarcopenia parameters? If so, what is the nature of this effect? Patients will undergo an exercise program three days a week for eight weeks. Outcomes will be assessed at baseline, on the first day after the treatment and 4 weeks after the end of the treatment.

연구 개요

상태

모집하지 않고 적극적으로

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

중재적

등록 (실제)

34

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Istanbul, 터키 (Türkiye)
        • Sisli Hamidiye Etfal Training and Research Hospital

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

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

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

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
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.
An 3 days a week for 8 weeks aerobic and balance exercises program
다른 이름들:
  • Aerobic and Balance Exercises
A 3 days a week for 8 weeks aerobic, balance and resistive exercises program
다른 이름들:
  • Aerobic, Balance and Resistive Exercises
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
An 3 days a week for 8 weeks aerobic and balance exercises program
다른 이름들:
  • Aerobic and Balance Exercises
A 3 days a week for 8 weeks aerobic, balance and resistive exercises program
다른 이름들:
  • Aerobic, Balance and Resistive Exercises

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Grip strenght
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
Grip strength is measured using a hydraulic hand dynamometer with the dominant hand.
Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
Chair Stand Test
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
Chair Stand Test is used to assess muscle function. Patients asked to sit and stand on a chair for 5 times.
Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
Gait Speed
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
Gait speed is assessed by measuring the time it takes the patient to walk a distance of 4 meters.
Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment

2차 결과 측정

결과 측정
측정값 설명
기간
Quadriceps Muscle Thickness Measurement
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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.
Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
Time-Up And Go Test
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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.
Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
SARC-F Questionnaire
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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.
Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
The Short Physical Performance Battery (SPPB)
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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.
Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
Berg Balance Scale
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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.
Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
The Parkinson's Disease Questionnaire-39 (PDQ-39)
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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.
Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
The Patient Health Questionnaire (PHQ)
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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.
Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
Katz Index of Independence in Activities of Daily Living
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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.
Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
The Montreal Cognitive Assessment (MoCA)
기간: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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.
Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment

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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

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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)

2025년 9월 1일

기본 완료 (추정된)

2026년 6월 15일

연구 완료 (추정된)

2026년 6월 15일

연구 등록 날짜

최초 제출

2026년 6월 1일

QC 기준을 충족하는 최초 제출

2026년 6월 1일

처음 게시됨 (실제)

2026년 6월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 1일

마지막으로 확인됨

2026년 6월 1일

추가 정보

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개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individual participant data will not be shared, as this is a single-center, academic study, and there is no plan or requirement to make the raw dataset publicly available.

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아니

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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