NCT07629063

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Completed
Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

10 months

First QC Date

June 1, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

Parkinson's DiseaseSarcopeniaExercise

Outcome Measures

Primary Outcomes (3)

  • Grip strenght

    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

    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

    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

Secondary Outcomes (9)

  • Quadriceps Muscle Thickness Measurement

    Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment

  • Time-Up And Go Test

    Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment

  • SARC-F Questionnaire

    Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment

  • The Short Physical Performance Battery (SPPB)

    Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment

  • Berg Balance Scale

    Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment

  • +4 more secondary outcomes

Study Arms (2)

Aerobic and Balance Exercise Group

ACTIVE COMPARATOR

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.

Other: Exercise

Aerobic, Balance and Resistive Exercise Group

EXPERIMENTAL

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

Other: Exercise

Interventions

An 3 days a week for 8 weeks aerobic and balance exercises program

Also known as: Aerobic and Balance Exercises
Aerobic and Balance Exercise Group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 31037806BACKGROUND
  • 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.

    PMID: 37898016BACKGROUND
  • 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.

    PMID: 32158202BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseSarcopeniaMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 5, 2026

Study Start

September 1, 2025

Primary Completion

June 15, 2026

Study Completion

June 15, 2026

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations