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Completed

NCT Number: NCT07629063

Effectiveness of Resistance Exercises Added to Aerobic and Balance Exercises in Parkinson's Disease

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

An 3 days a week for 8 weeks aerobic and balance exercises program

Other names: Aerobic and Balance Exercises

Primary outcomes

  1. Grip strenght

    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.

  2. Chair Stand Test

    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.

  3. Gait Speed

    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.

Secondary outcomes

  1. Quadriceps Muscle Thickness Measurement

    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.

  2. Time-Up And Go Test

    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.

  3. SARC-F Questionnaire

    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.

  4. The Short Physical Performance Battery (SPPB)

    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.

  5. Berg Balance Scale

    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.

  6. The Parkinson's Disease Questionnaire-39 (PDQ-39)

    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.

  7. The Patient Health Questionnaire (PHQ)

    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.

  8. Katz Index of Independence in Activities of Daily Living

    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.

  9. The Montreal Cognitive Assessment (MoCA)

    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.

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2026
Registry last updated
Jul 28, 2026

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.

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