NCT07165106

Brief Summary

The aim of this study was to investigate the effects of resistance and aerobic exercises on the following outcomes in patients with sarcopenic Parkinson's disease: Timed Up and Go Test (TUG), gait speed, Short Physical Performance Battery (SPPB), handgrip strength, Five-Times Sit-to-Stand Test, and MDS-UPDRS Part II scores.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

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
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

September 10, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

April 2, 2026

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

August 25, 2025

Last Update Submit

March 29, 2026

Conditions

Keywords

rehabilitationsarcopeniaexercises

Outcome Measures

Primary Outcomes (5)

  • Timed Up and Go Test (TUG Test)

    The Timed Up and Go (TUG) test measures mobility by timing a participant rising from a chair, walking 3 m, turning, and sitting down. Lower values indicate better performance. Unit of Measure: seconds

    BEFORE TREATMENT(WEEK 0),AT THE END OF TREATMENT (WEEK 6) AND AFTER TREATMENT (WEEK 12)

  • 4-Meter Walking Speed

    Usual-pace walking speed over a 4-meter course, recorded as distance divided by time. Higher values indicate better performance. Unit of Measure: meters/second

    BEFORE TREATMENT(WEEK 0),AT THE END OF TREATMENT (WEEK 6) AND AFTER TREATMENT (WEEK 12)

  • Short Physical Performance Battery (SPPB) Score

    Composite score including balance tests, 4-meter gait speed, and repeated chair stands; range 0 (worst) to 12 (best). Higher scores indicate better performance. Unit of Measure: score (0-12)

    BEFORE TREATMENT(WEEK 0),AT THE END OF TREATMENT (WEEK 6) AND AFTER TREATMENT (WEEK 12)

  • Handgrip Strength

    Maximal isometric handgrip strength of the dominant hand measured with a handheld dynamometer. Higher values indicate better strength

    BEFORE TREATMENT(WEEK 0),AT THE END OF TREATMENT (WEEK 6) AND AFTER TREATMENT (WEEK 12)

  • Five Times Chair Stand Test

    Time (in seconds) to rise from a chair and sit back down five consecutive times without using arms. Lower values indicate better performance. Unit of Measure: seconds

    BEFORE TREATMENT(WEEK 0),AT THE END OF TREATMENT (WEEK 6) AND AFTER TREATMENT (WEEK 12)

Secondary Outcomes (1)

  • MDS-UPDRS Part II: Motor Aspects of Experiences of Daily Living

    BEFORE TREATMENT(WEEK 0),AT THE END OF TREATMENT (WEEK 6) AND AFTER TREATMENT (WEEK 12)

Study Arms (3)

Conventional rehabilitation + Aerobic exercise

EXPERIMENTAL

Participants will receive a standard conventional rehabilitation program combined with supervised aerobic exercise training (e.g., treadmill ) according to guideline-based frequency, intensity, and duration.

Behavioral: Aerobic ExerciseBehavioral: Conventional Rehabilitation

Conventional rehabilitation + Resistance exercises

EXPERIMENTAL

Participants will receive a standard conventional rehabilitation program combined with supervised resistance exercise training targeting major muscle groups with free weights or elastic bands.

Behavioral: Resistance ExerciseBehavioral: Conventional Rehabilitation

Conventional rehabilitation

ACTIVE COMPARATOR

Participants will receive only the standard conventional rehabilitation program without any additional aerobic or resistance exercise.

Behavioral: Conventional Rehabilitation

Interventions

Participants in this arm will receive conventional rehabilitation combined with supervised resistance training using elastic bands, 3 times per week for 6 weeks. Exercises target major upper- and lower-limb and hip muscles. Each exercise is performed for 3 sets of 10 repetitions with 60-90 seconds rest. Initial band tension is set at the highest tolerable level and progressively increased. The program includes shoulder press, biceps curl, triceps extension, seated leg extension, calf raise, and lateral band walk. All sessions are supervised, emphasizing correct posture, controlled full range of motion, and avoidance of compensatory movements. Patients are guided with verbal and visual cues when necessary.

Also known as: Resistance training
Conventional rehabilitation + Resistance exercises

Participants in this group will receive conventional rehabilitation only, 5 days per week, 1 hour per day, for 6 weeks. The program includes upper and lower limb range of motion exercises, stretching, walking practice, balance and coordination training, proprioceptive exercises, posture correction, obstacle crossing, and turning in place. All sessions are delivered under clinical supervision, with emphasis on correct posture, safety, and full range of motion

Also known as: Conventional therapy
Conventional rehabilitationConventional rehabilitation + Aerobic exerciseConventional rehabilitation + Resistance exercises

Participants in this group will receive conventional rehabilitation in combination with supervised treadmill-based aerobic exercise three times per week for 6 weeks. Each exercise session will consist of a 5-minute warm-up, a 15-minute main exercise phase, and a 5-minute cool-down. Walking speed will be individualized based on participant tolerance and progressively increased under clinical supervision. Exercise intensity will be monitored using the modified Borg Rating of Perceived Exertion (scale 6-20). Weeks 1-2: Main exercise at Borg 10-11 (light-moderate). Weeks 3-4: Main exercise at Borg 11-12 (moderate). Weeks 5-6: Main exercise at Borg 12-13 (moderate-high). Cardiorespiratory responses will be monitored during all sessions, and treadmill speed will be gradually adjusted in accordance with improvements in exercise tolerance while maintaining safety.

Also known as: Aerobic training
Conventional rehabilitation + Aerobic exercise

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients aged 40-85 years with a clinical diagnosis of Parkinson's disease.
  • Diagnosis of sarcopenia according to the EWGSOP2 criteria.
  • Hoehn \& Yahr stage 2-3.
  • Ability and willingness to provide written informed consent according to the approved study consent form.

You may not qualify if:

  • Failure to meet diagnostic criteria for sarcopenia.
  • Hoehn \& Yahr stage 1 or 4.
  • History of malignancy.
  • Epilepsy.
  • History of cardiac pacemaker implantation.
  • Presence of congestive heart failure.
  • Orthopedic conditions affecting walking or balance.
  • Respiratory disorders impairing exercise capacity.
  • Uncontrolled hypertension.
  • Inability to cooperate with study procedures.
  • History of neuromuscular or vestibular disorders affecting gait or balance parameters.
  • Lack of willingness to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran University

Kırşehir, 40100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson DiseaseSarcopeniaMotor Activity

Interventions

ExerciseResistance Training

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 PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three groups with a exercise control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 10, 2025

Study Start

September 10, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

April 2, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations