Parkinson DiseaseNCT04619784
Effect of Pilates Application on Abdominal Muscle Function, Core Stability, Musculoskeletal Pain, Quality of Life, Anxiety and Depression in Parkinson's Patients
A study testing Pilates Exercises in people with Parkinson Disease and Pilates, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it is aimed to investigate the effect of Pilates application on abdominal muscle function, core stability, musculoskeletal pain, quality of life, anxiety and depression in Parkinson's Patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Pilates, Muscle Function
- What is being tested?
- Pilates Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Apr 2018to 31 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Idiopathic Parkinson's Disease
- Must be older 18 years old
- Must have 24 and above score on Mini Mental Test
- Must be the third or lower stage according to the Hoehn-Yahr staging
- Must have stable clinical status
Who cannot join
- Musculoskeletal or cognitive impairment at a level affecting evaluation and treatment
- Other neurological disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dokuz Eylul University
Izmir, 35340
Evrim Goz
About this study
Official title: The Effect of Pilates Application on Abdominal Muscle Function, Core Stability, Musculoskeletal Pain, Quality of Life, Anxiety and Depression in Parkinson's Patients
In this study, it is aimed to investigate the effect of Pilates application on abdominal muscle function, core stability, musculoskeletal pain, quality of life, anxiety and depression in Parkinson's Patients.
Read the detailed description
Objective: In this study, it is aimed to investigate the effect of Pilates application on abdominal muscle function, core stability, musculoskeletal pain, quality of life, anxiety and depression in Parkinson's Patients.
Method: The study included 15 Idiopathic Parkinson's Patients over 18 years of age, under stage 3 according to the Hoehn-Yahr clinical staging. Patients were divided into intervention and control groups. Pilates training was performed for 6 weeks, twice a week and 60 minutes per session in intervention group. Demographic features will be questioned and recorded in the data recording form through mutual interview in patients who meet the inclusion criteria; evaluations will be made regarding muscle thickness and pain. All patients will be evaluated before treatment, after treatment, at the 3rd and 6th months.
- Conditions
- Parkinson Disease, Pilates, Muscle Function
- Being tested
- Pilates Exercises, control
- 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 ExercisesOther
Patients will receive 12 sessions of pilates.
controlOther
Their routine medical treatments were continued
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Demographic features will be questioned and recorded in the data recording form through face to face interview in patients who meet the inclusion criteria; evaluations will be made regarding muscle thickness and pain. Patients will receive 12 sessions of pilates. Patients will be evaluated before treatment, after treatment, at the 3rd and 6th months. Receives: Other: Pilates Exercises |
| Control Group | Other | Demographic features will be questioned and recorded in the data recording form through face to face interview in patients who meet the inclusion criteria; evaluations will be made regarding muscle thickness and pain. Their routine medical treatments were continued Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Function
Muscle thickness measurement will be used to evaluate the function of transversus. Ultrasonography with a linear transducer (MHz) will use to measure the Transversus Abdominis thickness both at rest and during the abdominal drawing-in maneuver (ADIM). During ADIM, participants will be asked to abdominal hollowing which will be a gentle voluntary contraction of abdominal wall. All images are obtained at the end of expiration not to allow the effect of respiration on muscle thickness. Three measures are recorded in the both condition. The average values of measures are used in the data analysis.
Measured: Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Secondary outcomes (6)
Core stability
"Core" endurance and "core" power are the specific components of "core" stability and will be evaluated separately.
Measured: Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Musculoskeletal Pain
Musculoskeletal pain will be evaluated with The Nordic Musculoskeletal Questionnaire. Questionnaire includes 27 items exploring the presence of musculoskeletal symptoms during a 12-month period covering in nine different parts of the body (i.e. neck, shoulders, elbows, wrists/hands, upper back, lower back, hips/tights, knees, ankles/feet) [21]. It also has items pertaining to severity grades, determined according to functional status and the presence of musculoskeletal symptoms during the last seven days. All answers are given according to a dichotomous 'yes/no' response.The Turkish version of the NMQ has appropriate psychometric properties, including good test-retest reliability, internal consistency and construct validity.
Measured: Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Quality of Life
Quality of Life will be evaluated with 8-Item Parkinson's Disease Questionnaire / PDQ-8.The PDQ-8 is a brief form of the PDQ-39. One question from each of the eight domains on the PDQ-39 which are activities of daily living, bodily discomfort, cognition, communication, emotional well-being, mobility, social support, and stigma was chosen based on the strength of its correlation with the total domain score. Each question was scored from 0-4 points, and the scores were summed. The summed score was then divided by total possible score, and given as a percentage score out of 100.
Measured: Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Anxiety
Anxiety will be evaluated with Beck Anxiety Inventory. It is a 21-item questionnaire that includes 4-point Likert-type options with a score of 0-3 and measures the level of anxiety. The higher the total score indicates the severity of anxiety.
Measured: Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Pain intensity
Pain intensity will be evaluated with Visual Analog Scale. 10 cm long horizontal or vertical, numbered 1-10 forms are used.0 means no pain, 10 means unbearable pain.
Measured: Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Depression
Depression will be evaluated with Beck Depression Inventory. It is a 21-item scale. The items contain sentences of four degrees that progress from less to more, which the participant will evaluate himself. The scale can be scored between 0 and 63. The high total score indicates the severity of the depression.
Measured: Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start16 Apr 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evrim Goz, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619784
- Sponsor's protocol ID
- DokuzEU2
- Status last verified
- Nov 2020
- First submitted
- 4 Aug 2020
- Last updated
- 6 Nov 2020
- 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 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pilates Application on Abdominal Muscle Function, Core Stability, Musculoskeletal Pain, Quality of Life, Anxiety and Depression in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT04619784
- Acronym / sponsor ID
- DokuzEU2
- Conditions
- Parkinson Disease, Pilates, Muscle Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 6 Nov 2020 (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.
In this study, it is aimed to investigate the effect of Pilates application on abdominal muscle function, core stability, musculoskeletal pain, quality of life, anxiety and depression in Parkinson's Patients.
Detailed description
Objective: In this study, it is aimed to investigate the effect of Pilates application on abdominal muscle function, core stability, musculoskeletal pain, quality of life, anxiety and depression in Parkinson's Patients.
Method: The study included 15 Idiopathic Parkinson's Patients over 18 years of age, under stage 3 according to the Hoehn-Yahr clinical staging. Patients were divided into intervention and control groups. Pilates training was performed for 6 weeks, twice a week and 60 minutes per session in intervention group. Demographic features will be questioned and recorded in the data recording form through mutual interview in patients who meet the inclusion criteria; evaluations will be made regarding muscle thickness and pain. All patients will be evaluated before treatment, after treatment, at the 3rd and 6th months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Pilates ExercisesDemographic features will be questioned and recorded in the data recording form through face to face interview in patients who meet the inclusion criteria; evaluations will be made regarding muscle thickness and pain. Patients will receive 12 sessions of pilates. Patients will be evaluated before treatment, after treatment, at the 3rd and 6th months. |
| Control Group | Other | Other: controlDemographic features will be questioned and recorded in the data recording form through face to face interview in patients who meet the inclusion criteria; evaluations will be made regarding muscle thickness and pain. Their routine medical treatments were continued |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with Idiopathic Parkinson's Disease
- Must be older 18 years old
- Must have 24 and above score on Mini Mental Test
- Must be the third or lower stage according to the Hoehn-Yahr staging
- Must have stable clinical status
Key exclusion criteria (2 listed)
- Musculoskeletal or cognitive impairment at a level affecting evaluation and treatment
- Other neurological disease
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 ExercisesPatients will receive 12 sessions of pilates. | Other | Treatment Group |
| controlTheir routine medical treatments were continued | Other | Control Group |
Primary outcome
Muscle Function
Time frame: Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Muscle thickness measurement will be used to evaluate the function of transversus. Ultrasonography with a linear transducer (MHz) will use to measure the Transversus Abdominis thickness both at rest and during the abdominal drawing-in maneuver (ADIM). During ADIM, participants will be asked to abdominal hollowing which will be a gentle voluntary contraction of abdominal wall. All images are obtained at the end of expiration not to allow the effect of respiration on muscle thickness. Three measures are recorded in the both condition. The average values of measures are used in the data analysis.
6 secondary outcomes
Core stability
Time frame: Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Musculoskeletal Pain
Time frame: Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Quality of Life
Time frame: Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Anxiety
Time frame: Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Pain intensity
Time frame: Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Depression
Time frame: Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- 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.
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 Exercises in people with Parkinson Disease and Pilates, run by Dokuz Eylul University 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 5 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: status not confirmed, as of the sponsor's last update on 6 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evrim GOZ (02324124900, Evrim.goz@deu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Function (time frame: Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment). 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 6 Nov 2020.