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Investigation of the Effects of Clinical Pilates Exercises on Primary Caregivers of Special Needs Children

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ClinicalTrials.gov Identifier: NCT03729466
Recruitment Status : Unknown
Verified November 2018 by Yazgı Şentürk, Eastern Mediterranean University.
Recruitment status was:  Recruiting
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Yazgı Şentürk, Eastern Mediterranean University

Tracking Information
First Submitted Date  ICMJE October 30, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date November 2, 2018
Actual Study Start Date  ICMJE October 4, 2018
Estimated Primary Completion Date October 25, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of the Effects of Clinical Pilates Exercises on Primary Caregivers of Special Needs Children
Official Title  ICMJE Investigation of the Effects of Clinical Pilates Exercises on Primary Caregivers of Special Needs Children: Randomized Comparative Study
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
clinical pilates and control group
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sedentary Lifestyle
Intervention  ICMJE Other: clinical pilates
The intervention group will be performed in clinical pilates 45 to 60 minutes twice a week for 8 weeks.
Study Arms  ICMJE
  • No Intervention: Control group
    There will be no intervention for 8 weeks
  • Experimental: Intervention group
    clinical pilates will be given to the intervention group for 8 weeks
    Intervention: Other: clinical pilates
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 1, 2018)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 5, 2018
Estimated Primary Completion Date October 25, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Cyprus
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03729466
Other Study ID Numbers  ICMJE ETK00-2018-0154
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Yazgı Şentürk, Eastern Mediterranean University
Study Sponsor  ICMJE Eastern Mediterranean University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Berkiye Kırmızıgil Eastern mediterrean university
PRS Account Eastern Mediterranean University
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP