Effectiveness of Resistance Exercises Added to Aerobic and Balance Exercises in Parkinson's Disease
1. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Aktiv, nicht rekrutierend
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
34
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Istanbul, Türkei (türkiye)
- Sisli Hamidiye Etfal Training and Research Hospital
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver Komparator: 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
Andere Namen:
A 3 days a week for 8 weeks aerobic, balance and resistive exercises program
Andere Namen:
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Experimental: 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
Andere Namen:
A 3 days a week for 8 weeks aerobic, balance and resistive exercises program
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Grip strenght
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Quadriceps Muscle Thickness Measurement
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. September 2025
Primärer Abschluss (Geschätzt)
15. Juni 2026
Studienabschluss (Geschätzt)
15. Juni 2026
Studienanmeldedaten
Zuerst eingereicht
1. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
1. Juni 2026
Zuerst gepostet (Tatsächlich)
5. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
5. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
1. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Synucleinopathien
- Neurologische Manifestationen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Neuromuskuläre Manifestationen
- Pathologische Zustände, Anatomisch
- Neurodegenerative Krankheiten
- Bewegungsstörungen
- Parkinsonsche Störungen
- Erkrankungen der Basalganglien
- Muskelatrophie
- Atrophie
- Pathologische Zustände, Anzeichen und Symptome
- Verhalten
- Anzeichen und Symptome
- Parkinson Krankheit
- Sarkopenie
- Motorik
- Motorik
- Bewegung
- Phänomen des Bewegungsapparates muskuloskelettal
- Muskuloskelettaler und neuronales physiologisches Phänomen
- Übung
Andere Studien-ID-Nummern
- 3103 / 05.08.2025
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .