Parkinson's Disease (PD), Sarcopenia
Conditions
Keywords
Parkinson's Disease, Sarcopenia, Exercise
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.
Detailed description
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.
Interventions
OTHERExercise
An 3 days a week for 8 weeks aerobic and balance exercises program
Sponsors
Sisli Hamidiye Etfal Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grip strenght | Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment | Grip strength is measured using a hydraulic hand dynamometer with the dominant hand. |
| Chair Stand Test | 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. |
| Gait Speed | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quadriceps Muscle Thickness Measurement | 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-Up And Go Test | 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. |
| SARC-F Questionnaire | 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. |
| The Short Physical Performance Battery (SPPB) | 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. |
| Berg Balance Scale | 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. |
| The Parkinson's Disease Questionnaire-39 (PDQ-39) | 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. |
| The Patient Health Questionnaire (PHQ) | 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. |
| Katz Index of Independence in Activities of Daily Living | 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. |
| The Montreal Cognitive Assessment (MoCA) | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed