Sisli Hamidiye Etfal Training and Research Hospital
Istanbul, Turkey (Türkiye)
NCT Number: NCT07629063
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.
Looking for future studies?
Notify Me40 year–70 year
All sexes
Interventional
Not applicable
Istanbul, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An 3 days a week for 8 weeks aerobic and balance exercises program
Other names: Aerobic and Balance Exercises
Time frame: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
Grip strength is measured using a hydraulic hand dynamometer with the dominant hand.
Time frame: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
Chair Stand Test is used to assess muscle function. Patients asked to sit and stand on a chair for 5 times.
Time frame: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
Gait speed is assessed by measuring the time it takes the patient to walk a distance of 4 meters.
Time frame: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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.
Time frame: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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.
Time frame: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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.
Time frame: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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.
Time frame: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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.
Time frame: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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.
Time frame: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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.
Time frame: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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.
Time frame: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
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.
Sisli Hamidiye Etfal Training and Research Hospital
Other
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07443293
Basal Ganglia Diseases, Behavior
Vancouver, British Columbia, Canada
View Trial DetailsNCT07736014
Basal Ganglia Diseases, Brain Diseases
Foggia, FG, Italy
View Trial DetailsNCT07659405
Basal Ganglia Diseases, Brain Diseases
Aarhus, Denmark
View Trial DetailsNCT07422064
Basal Ganglia Diseases, Brain Diseases
Gaziantep, Turkey (Türkiye)
View Trial Details