Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-30 @ 5:42 AM
Study NCT ID:
NCT07165106
Status:
RECRUITING
Last Update Posted:
2025-09-18
First Post:
2025-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Resistance and Aerobic Exercises on Walking and Sarcopenic Parameters in Parkinson's Disease
Sponsor:
Ahi Evran University Education and Research Hospital
Organization:
Study Overview
Official Title:
Comparison of the Effects of Resistance and Aerobic Exercises Added to Conventional Rehabilitation Program on Walking and Sarcopenic Parameters in Patients With Sarcopenic Parkinson's Disease
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: