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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Yazgı Şentürk, Eastern Mediterranean University

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.

Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Other: clinical pilates Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: clinical pilates and control group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of the Effects of Clinical Pilates Exercises on Primary Caregivers of Special Needs Children: Randomized Comparative Study
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : October 25, 2018
Estimated Study Completion Date : December 5, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Other: clinical pilates
The intervention group will be performed in clinical pilates 45 to 60 minutes twice a week for 8 weeks.

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03729466

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Contact: Yazgı Şentürk 05428862868

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Eastern Mediterrean Universty Recruiting
Famagusta, Cyprus, 99450
Contact: Yazgı Şentürk    05428862868   
Contact: Berkiye Kırmızıgil    05428669679   
Sponsors and Collaborators
Eastern Mediterranean University
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Study Director: Berkiye Kırmızıgil Eastern mediterrean university
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Yazgı Şentürk, Principal Investigator Yazgı Şentürk, Eastern Mediterranean University Identifier: NCT03729466    
Other Study ID Numbers: ETK00-2018-0154
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yazgı Şentürk, Eastern Mediterranean University:
clinical pilates