Parkinson's Disease (PD)NCT07629063
Effectiveness of Resistance Exercises Added to Aerobic and Balance Exercises in Parkinson's Disease
A study testing Exercise in people with Parkinson's Disease (PD) and Sarcopenia, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Parkinson's Disease (PD), Sarcopenia
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Hamidiye Etfal Training and Research Hospital
Istanbul
About this study
Official 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.
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.
Read the 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.
- Conditions
- Parkinson's Disease (PD), Sarcopenia
- Being tested
- Exercise
- Keywords
- Parkinson's Disease, Sarcopenia, Exercise
- Medical subject headings
- Parkinson Disease, Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Aerobic and Balance Exercises
An 3 days a week for 8 weeks aerobic and balance exercises program
ExerciseOther
Also called Aerobic, Balance and Resistive Exercises
A 3 days a week for 8 weeks aerobic, balance and resistive exercises program
| Study group | Role | What they receive |
|---|---|---|
| Aerobic and Balance Exercise Group | Active comparator | Participants will receive an exercise program with 3 days a week for 8 weeks. Each treatment session will not exceed 45 minutes. Program will include aerobic exercises with 15 minutes on a treadmill, aiming not to exceed 85% of maximum heart rate and balance exercises including tandem stance, tandem walk, side stepping, backward walking, single leg stance. Receives: Other: Exercise |
| Aerobic, Balance and Resistive Exercise Group | Experimental | Participants will receive an exercise program with 3 days a week for 8 weeks. Each treatment session will not exceed 45 minutes. Program will include aerobic exercises with 15 minutes on a treadmill, aiming not to exceed 85% of maximum heart rate; balance exercises including tandem stance, tandem walk, side stepping, backward walking, single leg stance and resistive exercises for upper and lower extremity Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip strenght
Grip strength is measured using a hydraulic hand dynamometer with the dominant hand.
Measured: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
Chair Stand Test
Chair Stand Test is used to assess muscle function. Patients asked to sit and stand on a chair for 5 times.
Measured: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
Gait Speed
Gait speed is assessed by measuring the time it takes the patient to walk a distance of 4 meters.
Measured: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
Secondary outcomes (9)
Quadriceps Muscle Thickness Measurement
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.
Measured: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
Time-Up And Go Test
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.
Measured: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
SARC-F Questionnaire
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.
Measured: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
The Short Physical Performance Battery (SPPB)
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.
Measured: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
Berg Balance Scale
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.
Measured: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
The Parkinson's Disease Questionnaire-39 (PDQ-39)
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.
Measured: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
The Patient Health Questionnaire (PHQ)
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.
Measured: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
Katz Index of Independence in Activities of Daily Living
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.
Measured: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
The Montreal Cognitive Assessment (MoCA)
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.
Measured: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Sep 2025
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazlı İlgüner, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629063
- Sponsor's protocol ID
- 3103 / 05.08.2025
- Status last verified
- Jul 2026
- First submitted
- 1 Jun 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared, as this is a single-center, academic study, and there is no plan or requirement to make the raw dataset publicly available.
Publications
Leal LC, Abrahin O, Rodrigues RP, da Silva MC, Araujo AP, de Sousa EC, Pimentel CP, Cortinhas-Alves EA. Low-volume resistance training improves the functional capacity of older individuals with Parkinson's disease. Geriatr Gerontol Int. 2019 Jul;19(7):635-640. doi: 10.1111/ggi.13682. Epub 2019 Apr 29.
PubMed 31037806Kim R, Choi S, Kang N, Park K, Shin H, Lee H, Lee H, Jun JS, Jeon B, Byun K. Effects of high-intensity interval training and moderate-intensity continuous training on sarcopenia-related parameters in participants with Parkinson's disease: A 24-week randomized pilot trial substudy. Parkinsonism Relat Disord. 2023 Dec;117:105901. doi: 10.1016/j.parkreldis.2023.105901. Epub 2023 Oct 21.
PubMed 37898016Vieira de Moraes Filho A, Chaves SN, Martins WR, Tolentino GP, de Cassia Pereira Pinto Homem R, Landim de Farias G, Fischer BL, Oliveira JA, Pereira SKA, Vidal SE, Mota MR, Moreno Lima R, Jaco de Oliveira R. Progressive Resistance Training Improves Bradykinesia, Motor Symptoms and Functional Performance in Patients with Parkinson's Disease. Clin Interv Aging. 2020 Jan 23;15:87-95. doi: 10.2147/CIA.S231359. eCollection 2020.
PubMed 32158202
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07629063
- Acronym / sponsor ID
- 3103 / 05.08.2025
- Conditions
- Parkinson's Disease (PD), Sarcopenia
- Keywords
- Parkinson's Disease, Sarcopenia, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aerobic and Balance Exercise Group | Active comparator | Other: ExerciseParticipants will receive an exercise program with 3 days a week for 8 weeks. Each treatment session will not exceed 45 minutes. Program will include aerobic exercises with 15 minutes on a treadmill, aiming not to exceed 85% of maximum heart rate and balance exercises including tandem stance, tandem walk, side stepping, backward walking, single leg stance. |
| Aerobic, Balance and Resistive Exercise Group | Experimental | Other: ExerciseParticipants will receive an exercise program with 3 days a week for 8 weeks. Each treatment session will not exceed 45 minutes. Program will include aerobic exercises with 15 minutes on a treadmill, aiming not to exceed 85% of maximum heart rate; balance exercises including tandem stance, tandem walk, side stepping, backward walking, single leg stance and resistive exercises for upper and lower extremity |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Aerobic and Balance ExercisesAn 3 days a week for 8 weeks aerobic and balance exercises program | Other | Aerobic and Balance Exercise Group |
| ExerciseAlso: Aerobic, Balance and Resistive ExercisesA 3 days a week for 8 weeks aerobic, balance and resistive exercises program | Other | Aerobic, Balance and Resistive Exercise Group |
Primary outcome
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.
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.
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.
9 secondary outcomes
Quadriceps Muscle Thickness Measurement
Time frame: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
Time-Up And Go Test
Time frame: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
SARC-F Questionnaire
Time frame: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
The Short Physical Performance Battery (SPPB)
Time frame: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
Berg Balance Scale
Time frame: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
The Parkinson's Disease Questionnaire-39 (PDQ-39)
Time frame: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
The Patient Health Questionnaire (PHQ)
Time frame: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
Katz Index of Independence in Activities of Daily Living
Time frame: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
The Montreal Cognitive Assessment (MoCA)
Time frame: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Background: PubMed 31037806Leal LC, Abrahin O, Rodrigues RP, da Silva MC, Araujo AP, de Sousa EC, Pimentel CP, Cortinhas-Alves EA. Low-volume resistance training improves the functional capacity of older individuals with Parkinson's disease. Geriatr Gerontol Int. 2019 Jul;19(7):635-640. doi: 10.1111/ggi.13682. Epub 2019 Apr 29.
- Background: PubMed 37898016Kim R, Choi S, Kang N, Park K, Shin H, Lee H, Lee H, Jun JS, Jeon B, Byun K. Effects of high-intensity interval training and moderate-intensity continuous training on sarcopenia-related parameters in participants with Parkinson's disease: A 24-week randomized pilot trial substudy. Parkinsonism Relat Disord. 2023 Dec;117:105901. doi: 10.1016/j.parkreldis.2023.105901. Epub 2023 Oct 21.
- Background: PubMed 32158202Vieira de Moraes Filho A, Chaves SN, Martins WR, Tolentino GP, de Cassia Pereira Pinto Homem R, Landim de Farias G, Fischer BL, Oliveira JA, Pereira SKA, Vidal SE, Mota MR, Moreno Lima R, Jaco de Oliveira R. Progressive Resistance Training Improves Bradykinesia, Motor Symptoms and Functional Performance in Patients with Parkinson's Disease. Clin Interv Aging. 2020 Jan 23;15:87-95. doi: 10.2147/CIA.S231359. eCollection 2020.
- Individual participant dataSharing planned: No. Individual participant data will not be shared, as this is a single-center, academic study, and there is no plan or requirement to make the raw dataset publicly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Parkinson's Disease (PD) and Sarcopenia, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip strenght (time frame: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07629063, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.