Effectiveness of Resistance Exercises Added to Aerobic and Balance Exercises in Parkinson's Disease
1 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
34
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Istanbul, Turchia (Türkiye)
- Sisli Hamidiye Etfal Training and Research Hospital
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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
Altri nomi:
A 3 days a week for 8 weeks aerobic, balance and resistive exercises program
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
A 3 days a week for 8 weeks aerobic, balance and resistive exercises program
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Grip strenght
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Quadriceps Muscle Thickness Measurement
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 settembre 2025
Completamento primario (Stimato)
15 giugno 2026
Completamento dello studio (Stimato)
15 giugno 2026
Date di iscrizione allo studio
Primo inviato
1 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
1 giugno 2026
Primo Inserito (Effettivo)
5 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
5 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Sinucleinopatie
- Manifestazioni neurologiche
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Manifestazioni neuromuscolari
- Condizioni patologiche, anatomiche
- Malattie Neurodegenerative
- Disturbi del movimento
- Malattie parkinsoniane
- Malattie dei gangli basali
- Atrofia muscolare
- Atrofia
- Condizioni patologiche, segni e sintomi
- Comportamento
- Segni e sintomi
- Morbo di Parkinson
- Sarcopenia
- Attività motoria
- Attività motoria
- Movimento
- Fenomeni fisiologici muscoloscheletrici
- Fenomeni fisiologici muscoloscheletrici e neurali
- Esercizio
Altri numeri di identificazione dello studio
- 3103 / 05.08.2025
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .