Effectiveness of Resistance Exercises Added to Aerobic and Balance Exercises in Parkinson's Disease
1. juni 2026 opdateret af: 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.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
34
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Istanbul, Tyrkiet (Türkiye)
- Sisli Hamidiye Etfal Training and Research Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv 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
Andre navne:
A 3 days a week for 8 weeks aerobic, balance and resistive exercises program
Andre navne:
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Eksperimentel: 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
Andre navne:
A 3 days a week for 8 weeks aerobic, balance and resistive exercises program
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Grip strenght
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Quadriceps Muscle Thickness Measurement
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. september 2025
Primær færdiggørelse (Anslået)
15. juni 2026
Studieafslutning (Anslået)
15. juni 2026
Datoer for studieregistrering
Først indsendt
1. juni 2026
Først indsendt, der opfyldte QC-kriterier
1. juni 2026
Først opslået (Faktiske)
5. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Synukleinopatier
- Neurologiske manifestationer
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Neuromuskulære manifestationer
- Patologiske Tilstande, Anatomiske
- Neurodegenerative sygdomme
- Bevægelsesforstyrrelser
- Parkinsonlidelser
- Basal Ganglia Sygdomme
- Muskelatrofi
- Atrofi
- Patologiske tilstande, tegn og symptomer
- Opførsel
- Tegn og symptomer
- Parkinsons sygdom
- Sarkopeni
- Motorisk aktivitet
- Motorisk aktivitet
- Bevægelse
- Muskuloskeletale fysiologiske fænomener
- Muskuloskeletale og neurale fysiologiske fænomener
- Øvelse
Andre undersøgelses-id-numre
- 3103 / 05.08.2025
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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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