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

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.

Study Overview

• Status: Unknown
• Conditions: Sedentary Lifestyle
• Intervention / Treatment: Other: clinical pilates

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: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cyprus
  • Famagusta, Cyprus, 99450
    • Recruiting
    • Eastern Mediterrean Universty
    • Contact: Yazgı Şentürk; Phone Number: 05428862868; Email: yazgisntrk@gmail.com
    • Contact: Berkiye Kırmızıgil; Phone Number: 05428669679; Email: berkiyekirmizigil@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue severity scale	The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree	up to 8 weeks

Collaborators and Investigators

• Sponsor: Eastern Mediterranean University
• Investigators: Study Director: Berkiye Kırmızıgil, Eastern Mediterrean University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 4, 2018
• Primary Completion (ANTICIPATED): October 25, 2018
• Study Completion (ANTICIPATED): December 5, 2018

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: November 1, 2018
• First Posted (ACTUAL): November 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2018
• Last Update Submitted That Met QC Criteria: November 1, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: clinical pilates
• Other Study ID Numbers: ETK00-2018-0154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No