Clinical trial NCT03729466: Investigation of the Effects of Clinical Pilates Exercises on Primary Caregivers of Special Needs Children
Official title: Investigation of the Effects of Clinical Pilates Exercises on Primary Caregivers of Special Needs Children: Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sedentary Lifestyle
Keywords: clinical pilates
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: clinical pilates and control group
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fatigue severity scale
timeFrame: up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Eastern Mediterrean Universty
Study officials:
affiliation: Eastern mediterrean university
name: Berkiye Kırmızıgil
role: STUDY_DIRECTOR
References:
citation: 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.