Effectiveness of Resistance Exercises Added to Aerobic and Balance Exercises in Parkinson's Disease
1. června 2026 aktualizováno: 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.
Přehled studie
Postavení
Aktivní, ne nábor
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
34
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Istanbul, Turecko (Türkiye)
- Sisli Hamidiye Etfal Training and Research Hospital
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: 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
Ostatní jména:
A 3 days a week for 8 weeks aerobic, balance and resistive exercises program
Ostatní jména:
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Experimentální: 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
Ostatní jména:
A 3 days a week for 8 weeks aerobic, balance and resistive exercises program
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Grip strenght
Časové okno: 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
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Quadriceps Muscle Thickness Measurement
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. září 2025
Primární dokončení (Odhadovaný)
15. června 2026
Dokončení studie (Odhadovaný)
15. června 2026
Termíny zápisu do studia
První předloženo
1. června 2026
První předloženo, které splnilo kritéria kontroly kvality
1. června 2026
První zveřejněno (Aktuální)
5. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
5. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
1. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Synukleinopatie
- Neurologické projevy
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Neuromuskulární projevy
- Patologické stavy, anatomické
- Neurodegenerativní onemocnění
- Poruchy pohybu
- Parkinsonské poruchy
- Bazální gangliové choroby
- Svalová atrofie
- Atrofie
- Patologické stavy, příznaky a symptomy
- Chování
- Příznaky a symptomy
- Parkinsonova choroba
- Sarkopenie
- Motorická aktivita
- Motorická aktivita
- Hnutí
- Muskuloskeletální fyziologické jevy
- Muskuloskeletální a nervové fyziologické jevy
- Cvičení
Další identifikační čísla studie
- 3103 / 05.08.2025
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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