Effects of Resistance and Aerobic Exercises on Walking and Sarcopenic Parameters in Parkinson's Disease

NCT ID: NCT07165106

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-10

Study Completion Date

2026-01-01

Brief Summary

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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.

Detailed Description

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Female and male patients aged between 40 and 85 years, who meet the inclusion criteria, will be recruited from the Outpatient Clinic of Physical Medicine and Rehabilitation (PMR), Ahi Evran University Kırşehir Training and Research Hospital. A total of 30 participants will be enrolled in the study.

This is a prospective, randomized, controlled trial. Assessments will be performed at baseline (week 0), at the end of treatment (week 6), and at follow-up (week 12). Outcome measures will include:

Handgrip strength Timed Up and Go Test (TUG) 4-meter gait speed test Short Physical Performance Battery (SPPB) Five-Times Sit-to-Stand Test (5CST) MDS-UPDRS Part II questionnaire

In addition, at baseline, ultrasonographic measurement of anterior thigh muscle thickness will be performed. This value, expressed in millimeters, will be divided by the body mass index (BMI) to calculate the STAR (Sonographic Thigh Adjustment Ratio) index.Participants will be randomized into three treatment groups:

Group 3 (Conventional Rehabilitation Program):

Patients will receive a standard physical therapy program, 5 days per week, for 1 hour per session. The protocol will include range of motion exercises for upper and lower extremities, stretching, walking, balance and coordination training, proprioceptive exercises, postural exercises, obstacle negotiation training, and turning-in-place exercises.

Group 2 (Conventional Rehabilitation + Resistance Training):

In addition to the conventional program, patients will perform resistance exercises for major muscle groups of the upper and lower extremities using elastic resistance bands, 3 days per week.

Group 1 (Conventional Rehabilitation + Treadmill Training):

In addition to the conventional program, patients will undergo treadmill exercise consisting of a 5-minute warm-up, 15 minutes of main exercise, and 5 minutes of cool-down. Walking speed will be individually adjusted according to participant tolerance, and exercise intensity will be monitored using the Borg Rating of Perceived Exertion (RPE) scale. Treadmill speed will be progressively increased in subsequent sessions under controlled conditions.

Conditions

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PARKINSON DISEASE (Disorder) Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three groups with a exercise control group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional rehabilitation + Aerobic exercise

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.

Group Type EXPERIMENTAL

Aerobic Exercise

Intervention Type BEHAVIORAL

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.

Conventional Rehabilitation

Intervention Type BEHAVIORAL

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

Conventional rehabilitation + Resistance exercises

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

Group Type EXPERIMENTAL

Resistance Exercise

Intervention Type BEHAVIORAL

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.

Conventional Rehabilitation

Intervention Type BEHAVIORAL

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

Conventional rehabilitation

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

Group Type ACTIVE_COMPARATOR

Conventional Rehabilitation

Intervention Type BEHAVIORAL

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

Interventions

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Aerobic Exercise

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.

Intervention Type BEHAVIORAL

Resistance Exercise

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.

Intervention Type BEHAVIORAL

Conventional Rehabilitation

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Aerobic training Resistance training Conventional therapy

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahi Evran University Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nedime Seven Tas

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kırşehir Ahi Evran University

Kırşehir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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NEDİME SEVEN TAŞ

Role: CONTACT

+905448203214

FİGEN TUNCAY

Role: CONTACT

+905353046401

Other Identifiers

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AhiEvranUERH-FTR-NST-01

Identifier Type: -

Identifier Source: org_study_id

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