Sedentary LifestyleNCT03729466
Investigation of the Effects of Clinical Pilates Exercises on Primary Caregivers of Special Needs Children
A study testing clinical pilates in people with Sedentary Lifestyle, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
The aim of this research is to investigate the effectiveness of clinical Pilates exercises applied to primary caregivers of children with special needs, flexibility, muscle strength, endurance, cardiovascular endurance, fatigue, coping attitudes and quality of life, depression and anxiety. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- clinical pilates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCyprus
- Study dates
- 4 Oct 2018to 5 Dec 2018
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caring for children over 3 years of age≥1 with special needs,
- Caring for the child for at least 6 months, with or without blood connection (mother, father, nan, aunt, sibling, carer, etc.)
- Being between the ages of 18-55,
- Has not had regular exercise in the last 6 months (3 days a week, more than 20 minutes)
Who cannot join
- Have serious orthopaedic, neurological, rheumatologic and psychiatric problems that may prevent clinical Pilates exercises.
- Pregnancy
- Has had a traumatic injury or surgery in the last 6 months
Trial locations and contacts
1 site in 1 country.
Cyprus1 site, 1 recruiting
- Recruiting
Eastern Mediterrean Universty
Famagusta, 99450
Yazgı Şentürk, 05428862868, yazgisntrk@gmail.com
Berkiye Kırmızıgil, 05428669679, berkiyekirmizigil@yahoo.com
About this study
Official title: Investigation of the Effects of Clinical Pilates Exercises on Primary Caregivers of Special Needs Children: Randomized Comparative Study
The aim of this research is to investigate the effectiveness of clinical Pilates exercises applied to primary caregivers of children with special needs, flexibility, muscle strength, endurance, cardiovascular endurance, fatigue, coping attitudes and quality of life, depression and anxiety.
Read the detailed description
Individuals participating in the study will be randomly divided into two groups through the randomized allocation software program. The first group will be given Clinical Pilates exercise training, while the second group will be considered as the control group. The exercises will be applied to the group attending the Clinical Pilates exercise training for 45-60 minutes, twice a week for a total of 8 weeks. Each movement will consist of one set and 10 repetitions. In the Clinical Pilates program, equipment and exercises will be gradually increased. Equipment to be used throughout the Clinical Pilates program; Pilates cushion, Elastic resistant band (red, green, blue), Exercise ball (65 cm) In the Clinical Pilates group, the training session will start with the warm-up program, core stabilization training, clinical Pilates exercises will be applied to increase the postural smoothness and strength, and the exercise session will be terminated with the cooling period. The clinical Pilates group will be given 5 key elements of clinical Pilates (Respiratory-Centre focus- Chest placement - Shoulder placement - Head-neck placement) will be explained. No exercise program will be applied to the control group for 8 weeks. A sufficient number of trials will be conducted to enable participants to adapt to the evaluation and treatment. The evaluations will be done as pre-test and post-test for both groups and then the groups will be compared. Individuals who have agreed to participate in the study and have signed the information consent form will be included.
- Conditions
- Sedentary Lifestyle
- Being tested
- clinical pilates
- Keywords
- clinical pilates
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical pilatesOther
The intervention group will be performed in clinical pilates 45 to 60 minutes twice a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | There will be no intervention for 8 weeks |
| Intervention group | Experimental | clinical pilates will be given to the intervention group for 8 weeks Receives: Other: clinical pilates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue severity scale
The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start4 Oct 2018
- Primary completion25 Oct 2018 (estimated)
- Study completion5 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies 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
- clinical pilates and control group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yazgı Şentürk, Eastern Mediterranean University
- Investigators
- Berkiye Kırmızıgil, Study director, Eastern mediterrean university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729466
- Sponsor's protocol ID
- ETK00-2018-0154
- Status last verified
- Nov 2018
- First submitted
- 30 Oct 2018
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Senturk Y, Kirmizigil B, Tuzun EH. Effects of clinical Pilates on the fitness in people with children with disabilities: a randomized controlled trial. J Comp Eff Res. 2021 Apr;10(5):409-422. doi: 10.2217/cer-2020-0108. Epub 2021 Mar 12.
PubMed 33709771
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Clinical Pilates Exercises on Primary Caregivers of Special Needs Children: Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT03729466
- Acronym / sponsor ID
- ETK00-2018-0154
- Conditions
- Sedentary Lifestyle
- Keywords
- clinical pilates
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 25 Oct 2018 (estimated)
- Study completion
- 5 Dec 2018 (estimated)
- First posted
- 2 Nov 2018 (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 aim of this research is to investigate the effectiveness of clinical Pilates exercises applied to primary caregivers of children with special needs, flexibility, muscle strength, endurance, cardiovascular endurance, fatigue, coping attitudes and quality of life, depression and anxiety.
Detailed description
Individuals participating in the study will be randomly divided into two groups through the randomized allocation software program. The first group will be given Clinical Pilates exercise training, while the second group will be considered as the control group. The exercises will be applied to the group attending the Clinical Pilates exercise training for 45-60 minutes, twice a week for a total of 8 weeks. Each movement will consist of one set and 10 repetitions. In the Clinical Pilates program, equipment and exercises will be gradually increased. Equipment to be used throughout the Clinical Pilates program; Pilates cushion, Elastic resistant band (red, green, blue), Exercise ball (65 cm) In the Clinical Pilates group, the training session will start with the warm-up program, core stabilization training, clinical Pilates exercises will be applied to increase the postural smoothness and strength, and the exercise session will be terminated with the cooling period. The clinical Pilates group will be given 5 key elements of clinical Pilates (Respiratory-Centre focus- Chest placement - Shoulder placement - Head-neck placement) will be explained. No exercise program will be applied to the control group for 8 weeks. A sufficient number of trials will be conducted to enable participants to adapt to the evaluation and treatment. The evaluations will be done as pre-test and post-test for both groups and then the groups will be compared. Individuals who have agreed to participate in the study and have signed the information consent form will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- clinical pilates and control group
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –There will be no intervention for 8 weeks |
| Intervention group | Experimental | Other: clinical pilatesclinical pilates will be given to the intervention group for 8 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Caring for children over 3 years of age≥1 with special needs,
- Caring for the child for at least 6 months, with or without blood connection (mother, father, nan, aunt, sibling, carer, etc.)
- Being between the ages of 18-55,
- Has not had regular exercise in the last 6 months (3 days a week, more than 20 minutes)
Key exclusion criteria (3 listed)
- Have serious orthopaedic, neurological, rheumatologic and psychiatric problems that may prevent clinical Pilates exercises.
- Pregnancy
- Has had a traumatic injury or surgery in the last 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 |
|---|---|---|
| clinical pilatesThe intervention group will be performed in clinical pilates 45 to 60 minutes twice a week for 8 weeks. | Other | Intervention group |
Primary outcome
Fatigue severity scale
Time frame: up to 8 weeks
The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Derived from this study: PubMed 33709771Senturk Y, Kirmizigil B, Tuzun EH. Effects of clinical Pilates on the fitness in people with children with disabilities: a randomized controlled trial. J Comp Eff Res. 2021 Apr;10(5):409-422. doi: 10.2217/cer-2020-0108. Epub 2021 Mar 12.
- Individual participant dataSharing planned: Undecided
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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.
Berkiye Kırmızıgil study director
Eastern mediterrean university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clinical pilates in people with Sedentary Lifestyle, run by Eastern Mediterranean University at 1 site in Cyprus.
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 3 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 2 Nov 2018. 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 Cyprus. 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 Yazgı Şentürk (05428862868, yazgisntrk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue severity scale (time frame: up to 8 weeks). 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 NCT03729466, which also lists 1 linked publication.
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 2 Nov 2018.