NCT03729466

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2018

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2018

Completed
Last Updated

November 2, 2018

Status Verified

November 1, 2018

Enrollment Period

21 days

First QC Date

October 30, 2018

Last Update Submit

November 1, 2018

Conditions

Keywords

clinical pilates

Outcome Measures

Primary Outcomes (1)

  • Fatigue severity scale

    The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree

    up to 8 weeks

Study Arms (2)

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

Other: clinical pilates

Interventions

The intervention group will be performed in clinical pilates 45 to 60 minutes twice a week for 8 weeks.

Intervention group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterrean Universty

Famagusta, 99450, Cyprus

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Berkiye Kırmızıgil

    Eastern mediterrean university

    STUDY DIRECTOR

Central Study Contacts

Yazgı Şentürk

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: clinical pilates and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator Yazgı Şentürk

Study Record Dates

First Submitted

October 30, 2018

First Posted

November 2, 2018

Study Start

October 4, 2018

Primary Completion

October 25, 2018

Study Completion

December 5, 2018

Last Updated

November 2, 2018

Record last verified: 2018-11

Locations