Parkinson DiseaseNCT04928833
Investigation of the Effects of Pilates Training in Parkinson Patients
A study testing Pilates Training in people with Parkinson Disease and Pilates, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to examine the effects of Pilates training in Parkinson's Patients. The study included 34 Parkinson's patients between Hoehn \& Yahr Stage 1-2.5. Pilates training was applied to the Pilates group for 8 weeks, 3 days per week. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson Disease, Pilates, Core Stability
- What is being tested?
- Pilates Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 1 May 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- After providing information about the research, agreeing to participate in the research
- Being 40 years or older
- Being diagnosed with '' Idiopathic Parkinson's Disease '' by a specialist
- To be between 1-2.5 values according to Hoehn and Yahr (H\&Y) Scale
Who cannot join
- Standardized Mini Mental Test score is less than 24
- Presence of cardiovascular, pulmonary, orthopedic or other medical conditions that limit participation in Pilates training
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdogan University
Güneysu, Rize Province, 53390
About this study
This study was planned to examine the effects of Pilates training in Parkinson's Patients. The study included 34 Parkinson's patients between Hoehn \& Yahr Stage 1-2.5. Pilates training was applied to the Pilates group for 8 weeks, 3 days per week. To the control group; Breathing exercises, active range of motion exercises and relaxation exercises were given as a home program 3 days per week for 8 weeks. It was concluded that Pilates training performed to Parkinson's patients 3 times a week for 8 weeks was effective on "core" stability, thickness of "core" muscles, functional exercise capacity, motor functions, freezing, fatigue and QOL.
Read the detailed description
This study was planned to examine the effects of Pilates training, which is a "core" stability based exercise method that improves body alignment, postural control and balance, on "core" stability, the thickness of the "core" muscles, functional exercise capacity, motor functions, freezing, fatigue and daily life activities (ADLs) in Parkinson's Patients. The study included 34 Parkinson's patients between Hoehn \& Yahr Stage 1-2.5. The patients were randomly divided into two groups as as Pilates (n: 17) and control (n: 17). Pilates training was applied to the Pilates group for 8 weeks, 3 days per week. To the control group; Breathing exercises, active range of motion exercises and relaxation exercises were given as a home program 3 days per week for 8 weeks. The "core" power with the "sit-ups" and the modified "push-ups" tests, the "core" endurans with lateral bridge, trunk flexor endurance and "prone bridge" tests, the thickness of the "core" muscles by ultrasonography, functional strength of the lower limbs with 5 Times Sit Up Test (5TSST), balance with the Berg Balance Scale (BBS), functional mobility; with the Timed Up and Go Test (TUG), functional exercise capacity and walking with the 6-Minute Walk Test (6-MWT), motor impairment with the United Parkinson's Disease Rating Scale (UPDRS)-III, freezing with Freezing of Gait Questionnaire (FOGQ), fatigue with Parkinson's Fatigue Scale (PFS-16), ADLs with UPDRS-II, quality of life (QOL) with Parkinson's Disease Questionnaire-39 (PDQ-39) were evaluated before and after treatment.
- Conditions
- Parkinson Disease, Pilates, Core Stability, Balance, Quality of Life
- Being tested
- Pilates Training, Control group
- Keywords
- Parkinson Disease, Pilates, Core Stability, Balance, Quality of Life
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates TrainingOther
Pilates training was carried out as group exercises for about 1 hour, 3 days a week for 8 weeks. Before starting the exercise training, all subjects were taught the key elements of Pilates in 1 session. Pilates training started with standing exercises for warming up and centering in the supine position. Training continued with upper and lower extremity movements. The intensity of the exercises was increased using different positions and elastic bands. Stretching exercises and posture exercises were used during the cooling period. All exercises were started with 10 repetitions and then increased to 20. In order for the patients to perform the movements correctly, each movement was first demonstrated by the physiotherapist. The movements that the patients could not do were applied by modifying them in a suitable way.
Control groupOther
Breathing exercises, active range of motion exercises and relaxation exercises were given to the control group as a home program. They were asked to do the exercises 3 days a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pilates Group | Experimental | Pilates training was carried out as group exercises for about 1 hour, 3 days a week for 8 weeks. Receives: Other: Pilates Training |
| Control Group | Active comparator | Breathing exercises, active range of motion exercises and relaxation exercises were given to the control group as a home program. They were asked to do the exercises 3 days a week for 8 weeks. Receives: Other: Control group |
| Evaluation of 'Core' Stability | No intervention | "Core" stability was evaluated with two important dimensions, "core" strength and endurance tests. |
| Ultrasound Examination of M. Transversus Abdominus and M. Multifidus | No intervention | M. transversus abdominus (TrA) and m. multifidus (MF) muscles were visualized by ultrasonography and the evaluations were performed by an experienced radiologist who was blind to the case groups. |
| Evaluation of Lower Extremity Functional Strength | No intervention | Lower extremity functional strength was evaluated with the 5-Times Sit-and-Stand Test. |
| Evaluation of Balance | No intervention | Balance was evaluated using the Berg Balance Scale (BBS). |
| Evaluation of Functional Mobility | No intervention | Functional mobility was evaluated using the Timed Up and Go Test (TUG). |
| Evaluation of Functional Exercise Capacity | No intervention | Functional exercise capacity was evaluated using the 6 Minute Walking Test (6-MWT). |
| Activities of Daily Living and Evaluation of Motor Impairment | No intervention | Activities of daily living and motor impairment were evaluated with activities of daily living (II) and motor impairment (III) sub-dimensions of the Unified Parkinson's Disease Rating Scale (UPDRS). |
| Evaluation of Freezing | No intervention | The Freezing of Gait Questionnaire (FOGQ) was used to identify and evaluate the subjective perception of Parkinson's patients regarding the severity and effect of freezing on gait performance. |
| Evaluation of Fatigue | No intervention | Fatigue, one of the non-motor findings associated with Parkinson's, was evaluated with the Parkinson's Fatigue Scale-16 (PFS-16). |
| Evaluation of Quality of Life | No intervention | Quality of Life was evaluated with Parkinson's Disease Questionnaire-39 (PDQ-39). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the Strength of "Core" Muscles
The strength of the trunk muscles was evaluated with 'sit-up' and modified 'push-up' tests. The number of times the subjects could perform each test for 30 seconds was recorded. Each measurement was made twice and the best measurement was used in statistical analysis.
Measured: 8 weeks
Evaluation of the Endurance of "Core" Muscles
Static endurance of the "core" muscles was evaluated using the lateral bridge test defined by McGill, the trunk flexor endurance test and the "prone bridge" test. The time in which the subjects could maintain the test position was recorded in seconds using a stopwatch. Each measurement was made twice and the best measurement was used in statistical analysis. The test was terminated if it disturbed the test position.
Measured: 8 weeks
Ultrasound Examination of M. Transversus Abdominus and M. Multifidus
- transversus abdominus (TrA) and m. multifidus (MF) muscles were visualized by ultrasonography and the evaluations were performed by an experienced radiologist who was blind to the case groups. Ultrasound recordings were made using B-mode ultrasound. Each measurement was taken 3 times and the average value of 3 measurements was recorded in mm for statistical analysis.
Measured: 8 weeks
Evaluation of Lower Extremity Functional Strength
Lower extremity functional strength was evaluated with the 5-Times Sit-and-Stand Test. The test was performed twice, one trial, and the last measurement was used in statistical analysis.
Measured: 8 weeks
Evaluation of Balance
Balance was evaluated using the Berg Balance Scale (BBS). BBS tests were performed using the materials specified in the directive and in accordance with the instructions. The total score ranges from 0-56, with higher scores indicating better balance.
Measured: 8 weeks
Evaluation of Functional Mobility
Functional mobility was evaluated using the Timed Up and Go Test (TUG). This test; The duration was recorded and applied during the single-task and dual-task (motor and cognitive). Testing for single task was carried out in accordance with the instruction. In dual-motor duty, while holding an empty tray from the case with both hands; In the dual-cognitive task, he was asked to stand up and walk, turn around and come back and sit on the chair, counting 1 each backwards from a certain number (any number from 20 to 100). The time was recorded with a stopwatch. The test was performed twice, one trial, and the last measurement was used in statistical analysis.
Measured: 8 weeks
Evaluation of Functional Exercise Capacity
Functional exercise capacity was evaluated using the 6 Minute Walking Test (6-MWT). The test was performed in accordance with the American Thoracic Society criteria.
Normal values of 6-MWT are calculated approximately according to age, gender, height and weight in healthy adults. In this study, using reference suggested by Gibbons et al. "Estimated 6-MWT distance" and the rate of reaching the maximal heart rate at the end of 6-MWT were calculated.
Measured: 8 weeks
Activities of Daily Living and Evaluation of Motor Impairment
Activities of daily living and motor impairment were evaluated with activities of daily living (II) and motor impairment (III) sub-dimensions of the Unified Parkinson's Disease Rating Scale (UPDRS). The total score ranges from 0-108, with a higher score indicating a more serious disorder.
Measured: 8 weeks
Evaluation of Freezing
The Freezing of Gait Questionnaire (FOGQ) was used to identify and evaluate the subjective perception of Parkinson's patients regarding the severity and effect of freezing on gait performance. The total score ranges from 0-24, with a higher score meaning that a person's walking performance is more affected by freezing.
Measured: 8 weeks
Evaluation of Fatigue
Fatigue, one of the non-motor findings associated with Parkinson's, was evaluated with the Parkinson's Fatigue Scale-16 (PFS-16). The total score ranged from 16 to 80, and a total of 8 points or more was considered tired.
Measured: 8 weeks
Evaluation of Quality of Life
Quality of Life was evaluated with Parkinson's Disease Questionnaire-39 (PDQ-39). This questionnaire is the most frequently used specific health status measure in PD patients. The total score ranges from 0-100, and lower scores better reflect perceived quality of life.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start1 Nov 2019
- Primary completion1 Feb 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Çağlar, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- DERYA CAGLAR, MSc, Study director, Recep Tayyip Erdogan University Vocational School of Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928833
- Sponsor's protocol ID
- 2019/10
- Status last verified
- Jun 2021
- First submitted
- 27 Apr 2021
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Pilates Training in Parkinson Patients
- ClinicalTrials.gov ID
- NCT04928833
- Acronym / sponsor ID
- 2019/10
- Conditions
- Parkinson Disease, Pilates, Core Stability, Balance, Quality of Life
- Keywords
- Parkinson Disease, Pilates, Core Stability, Balance, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 16 Jun 2021 (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.
This study was planned to examine the effects of Pilates training in Parkinson's Patients. The study included 34 Parkinson's patients between Hoehn \& Yahr Stage 1-2.5. Pilates training was applied to the Pilates group for 8 weeks, 3 days per week. To the control group; Breathing exercises, active range of motion exercises and relaxation exercises were given as a home program 3 days per week for 8 weeks. It was concluded that Pilates training performed to Parkinson's patients 3 times a week for 8 weeks was effective on "core" stability, thickness of "core" muscles, functional exercise capacity, motor functions, freezing, fatigue and QOL.
Detailed description
This study was planned to examine the effects of Pilates training, which is a "core" stability based exercise method that improves body alignment, postural control and balance, on "core" stability, the thickness of the "core" muscles, functional exercise capacity, motor functions, freezing, fatigue and daily life activities (ADLs) in Parkinson's Patients. The study included 34 Parkinson's patients between Hoehn \& Yahr Stage 1-2.5. The patients were randomly divided into two groups as as Pilates (n: 17) and control (n: 17). Pilates training was applied to the Pilates group for 8 weeks, 3 days per week. To the control group; Breathing exercises, active range of motion exercises and relaxation exercises were given as a home program 3 days per week for 8 weeks. The "core" power with the "sit-ups" and the modified "push-ups" tests, the "core" endurans with lateral bridge, trunk flexor endurance and "prone bridge" tests, the thickness of the "core" muscles by ultrasonography, functional strength of the lower limbs with 5 Times Sit Up Test (5TSST), balance with the Berg Balance Scale (BBS), functional mobility; with the Timed Up and Go Test (TUG), functional exercise capacity and walking with the 6-Minute Walk Test (6-MWT), motor impairment with the United Parkinson's Disease Rating Scale (UPDRS)-III, freezing with Freezing of Gait Questionnaire (FOGQ), fatigue with Parkinson's Fatigue Scale (PFS-16), ADLs with UPDRS-II, quality of life (QOL) with Parkinson's Disease Questionnaire-39 (PDQ-39) were evaluated before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Pilates Group | Experimental | Other: Pilates TrainingPilates training was carried out as group exercises for about 1 hour, 3 days a week for 8 weeks. |
| Control Group | Active comparator | Other: Control groupBreathing exercises, active range of motion exercises and relaxation exercises were given to the control group as a home program. They were asked to do the exercises 3 days a week for 8 weeks. |
| Evaluation of 'Core' Stability | No intervention | –"Core" stability was evaluated with two important dimensions, "core" strength and endurance tests. |
| Ultrasound Examination of M. Transversus Abdominus and M. Multifidus | No intervention | –M. transversus abdominus (TrA) and m. multifidus (MF) muscles were visualized by ultrasonography and the evaluations were performed by an experienced radiologist who was blind to the case groups. |
| Evaluation of Lower Extremity Functional Strength | No intervention | –Lower extremity functional strength was evaluated with the 5-Times Sit-and-Stand Test. |
| Evaluation of Balance | No intervention | –Balance was evaluated using the Berg Balance Scale (BBS). |
| Evaluation of Functional Mobility | No intervention | –Functional mobility was evaluated using the Timed Up and Go Test (TUG). |
| Evaluation of Functional Exercise Capacity | No intervention | –Functional exercise capacity was evaluated using the 6 Minute Walking Test (6-MWT). |
| Activities of Daily Living and Evaluation of Motor Impairment | No intervention | –Activities of daily living and motor impairment were evaluated with activities of daily living (II) and motor impairment (III) sub-dimensions of the Unified Parkinson's Disease Rating Scale (UPDRS). |
| Evaluation of Freezing | No intervention | –The Freezing of Gait Questionnaire (FOGQ) was used to identify and evaluate the subjective perception of Parkinson's patients regarding the severity and effect of freezing on gait performance. |
| Evaluation of Fatigue | No intervention | –Fatigue, one of the non-motor findings associated with Parkinson's, was evaluated with the Parkinson's Fatigue Scale-16 (PFS-16). |
| Evaluation of Quality of Life | No intervention | –Quality of Life was evaluated with Parkinson's Disease Questionnaire-39 (PDQ-39). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- After providing information about the research, agreeing to participate in the research
- Being 40 years or older
- Being diagnosed with '' Idiopathic Parkinson's Disease '' by a specialist
- To be between 1-2.5 values according to Hoehn and Yahr (H\&Y) Scale
Key exclusion criteria (2 listed)
- Standardized Mini Mental Test score is less than 24
- Presence of cardiovascular, pulmonary, orthopedic or other medical conditions that limit participation in Pilates training
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 |
|---|---|---|
| Pilates TrainingPilates training was carried out as group exercises for about 1 hour, 3 days a week for 8 weeks. Before starting the exercise training, all subjects were taught the key elements of Pilates in 1 session. Pilates training started with standing exercises for warming up and centering in the supine position. Training continued with upper and lower extremity movements. The intensity of the exercises was increased using different positions and elastic bands. Stretching exercises and posture exercises were used during the cooling period. All exercises were started with 10 repetitions and then increased to 20. In order for the patients to perform the movements correctly, each movement was first demonstrated by the physiotherapist. The movements that the patients could not do were applied by modifying them in a suitable way. | Other | Pilates Group |
| Control groupBreathing exercises, active range of motion exercises and relaxation exercises were given to the control group as a home program. They were asked to do the exercises 3 days a week for 8 weeks. | Other | Control Group |
Primary outcome
Evaluation of the Strength of "Core" Muscles
Time frame: 8 weeks
The strength of the trunk muscles was evaluated with 'sit-up' and modified 'push-up' tests. The number of times the subjects could perform each test for 30 seconds was recorded. Each measurement was made twice and the best measurement was used in statistical analysis.
Evaluation of the Endurance of "Core" Muscles
Time frame: 8 weeks
Static endurance of the "core" muscles was evaluated using the lateral bridge test defined by McGill, the trunk flexor endurance test and the "prone bridge" test. The time in which the subjects could maintain the test position was recorded in seconds using a stopwatch. Each measurement was made twice and the best measurement was used in statistical analysis. The test was terminated if it disturbed the test position.
Ultrasound Examination of M. Transversus Abdominus and M. Multifidus
Time frame: 8 weeks
M. transversus abdominus (TrA) and m. multifidus (MF) muscles were visualized by ultrasonography and the evaluations were performed by an experienced radiologist who was blind to the case groups. Ultrasound recordings were made using B-mode ultrasound. Each measurement was taken 3 times and the average value of 3 measurements was recorded in mm for statistical analysis.
Evaluation of Lower Extremity Functional Strength
Time frame: 8 weeks
Lower extremity functional strength was evaluated with the 5-Times Sit-and-Stand Test. The test was performed twice, one trial, and the last measurement was used in statistical analysis.
Evaluation of Balance
Time frame: 8 weeks
Balance was evaluated using the Berg Balance Scale (BBS). BBS tests were performed using the materials specified in the directive and in accordance with the instructions. The total score ranges from 0-56, with higher scores indicating better balance.
Evaluation of Functional Mobility
Time frame: 8 weeks
Functional mobility was evaluated using the Timed Up and Go Test (TUG). This test; The duration was recorded and applied during the single-task and dual-task (motor and cognitive). Testing for single task was carried out in accordance with the instruction. In dual-motor duty, while holding an empty tray from the case with both hands; In the dual-cognitive task, he was asked to stand up and walk, turn around and come back and sit on the chair, counting 1 each backwards from a certain number (any number from 20 to 100). The time was recorded with a stopwatch. The test was performed twice, one trial, and the last measurement was used in statistical analysis.
Evaluation of Functional Exercise Capacity
Time frame: 8 weeks
Functional exercise capacity was evaluated using the 6 Minute Walking Test (6-MWT). The test was performed in accordance with the American Thoracic Society criteria. Normal values of 6-MWT are calculated approximately according to age, gender, height and weight in healthy adults. In this study, using reference suggested by Gibbons et al. "Estimated 6-MWT distance" and the rate of reaching the maximal heart rate at the end of 6-MWT were calculated.
Activities of Daily Living and Evaluation of Motor Impairment
Time frame: 8 weeks
Activities of daily living and motor impairment were evaluated with activities of daily living (II) and motor impairment (III) sub-dimensions of the Unified Parkinson's Disease Rating Scale (UPDRS). The total score ranges from 0-108, with a higher score indicating a more serious disorder.
Evaluation of Freezing
Time frame: 8 weeks
The Freezing of Gait Questionnaire (FOGQ) was used to identify and evaluate the subjective perception of Parkinson's patients regarding the severity and effect of freezing on gait performance. The total score ranges from 0-24, with a higher score meaning that a person's walking performance is more affected by freezing.
Evaluation of Fatigue
Time frame: 8 weeks
Fatigue, one of the non-motor findings associated with Parkinson's, was evaluated with the Parkinson's Fatigue Scale-16 (PFS-16). The total score ranged from 16 to 80, and a total of 8 points or more was considered tired.
Evaluation of Quality of Life
Time frame: 8 weeks
Quality of Life was evaluated with Parkinson's Disease Questionnaire-39 (PDQ-39). This questionnaire is the most frequently used specific health status measure in PD patients. The total score ranges from 0-100, and lower scores better reflect perceived quality of life.
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 16 Jun 2021.
- Individual participant dataSharing planned: No
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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.
DERYA CAGLAR, MSc study director
Recep Tayyip Erdogan University Vocational School of Physical Therapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates Training in people with Parkinson Disease and Pilates, run by Recep Tayyip Erdogan University 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 2 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 16 Jun 2021. 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?
Evaluation of the Strength of "Core" Muscles (time frame: 8 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2021.