Effectiveness of Resistance Exercises Added to Aerobic and Balance Exercises in Parkinson's Disease
26. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
34
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Istanbul, Tyrkia (Türkiye)
- Şişli Hamidiye Etfal Training and Research Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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 navn:
A 3 days a week for 8 weeks aerobic, balance and resistive exercises program
Andre navn:
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Eksperimentell: 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 navn:
A 3 days a week for 8 weeks aerobic, balance and resistive exercises program
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. september 2025
Primær fullføring (Faktiske)
15. juni 2026
Studiet fullført (Faktiske)
15. juni 2026
Datoer for studieregistrering
Først innsendt
1. juni 2026
Først innsendt som oppfylte QC-kriteriene
1. juni 2026
Først lagt ut (Faktiske)
5. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Synukleinopatier
- Nevrologiske manifestasjoner
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Nevromuskulære manifestasjoner
- Patologiske tilstander, anatomiske
- Nevrodegenerative sykdommer
- Bevegelsesforstyrrelser
- Parkinsonlidelser
- Basal ganglia sykdommer
- Muskelatrofi
- Atrofi
- Patologiske tilstander, tegn og symptomer
- Oppførsel
- Tegn og symptomer
- Parkinsons sykdom
- Sarkopeni
- Motorisk aktivitet
- Motorisk aktivitet
- Bevegelse
- Muskel- og skjelettfysiologiske fenomener
- Muskel- og skjelett og nevrale fysiologiske fenomener
- Øvelse
Andre studie-ID-numre
- 3103 / 05.08.2025
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .