Does Reformer Pilates Exercise Improve Cognitive Functions in Sedentary Women?

• ClinicalTrials.gov Identifier: NCT05932004
• Recruitment Status: Not yet recruiting
• First Posted: July 6, 2023
• Last Update Posted: July 6, 2023
• Sponsor: Atılım University
• Information provided by (Responsible Party): Atılım University

Tracking Information

• First Submitted Date: June 27, 2023
• First Posted Date: July 6, 2023
• Last Update Posted Date: July 6, 2023
• Estimated Study Start Date: June 30, 2023
• Estimated Primary Completion Date: August 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 27, 2023)

• Demographic information [ Time Frame: Up to one month ]
  Demographic information such as age, height, weight, education level and smoking of all individuals participating in the study will be questioned.
• Stroop Test [ Time Frame: Up to one month ]
  The Stroop Test Form will be used to evaluate the cognitive functions of the participants such as attention, reaction inhibition, and information processing.
• Right-Left Discrimination [ Time Frame: Up to one month ]
  Motor imaging technique left/right discrimination will be used as cognitive evaluation.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: June 27, 2023)

Assessment of sleep quality and disorder [ Time Frame: Up to one month ]

The Pittsburgh Sleep Quality Index will be used to evaluate the sleep quality and disorder of the individuals participating in the study in the past month.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Does Reformer Pilates Exercise Improve Cognitive Functions in Sedentary Women?
• Official Title: Does Reformer Pilates Exercise Improve Cognitive Functions in Sedentary Women? A Randomized Controlled Study.

Brief Summary

The reformer is an apparatus on which to perform the foot work and the body in a comfortable, non weight-bearing supine position and keeps the muscles in balance. Studies on Pilates generally include individuals with chronic diseases, geriatric and obese individuals also active women.

The aim of this study was to investigate the effect of reformer Pilates exercises on cognitive functions in sedentary women

• Detailed Description: A total of 44 sedentary women aged between 24-50 will be randomized into two groups. The reformer Pilates group will receivea 6-week exercise program (45 minutes/twice per week) , while the participants in the control group will be selected from those on the exercise list who will start exercise after the study finishes, but are on a waiting exercise program list. Outcomes measured before and after the interventions are, right/left discrimination and scores of two questionnaires: Stroop Test and The Pittsburgh Sleep Quality Index.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

prospective randomized controlled study

Masking: Single (Participant)
Masking Description:

Participant will not informed about the intervention

Primary Purpose: Treatment

• Condition: Reformer Pilates Exercise, Cognitive Performans

Intervention

Other: Reformer pilates exercise

The reformer Pilates group will receivea 6-week exercise program (45 minutes/twice per week) , while the participants in the control group will be selected from those on the exercise list who will start exercise after the study finishes, but are on a waiting exercise program list

Study Arms

• Reformer pilates group
  Reformer pilates
  Intervention: Other: Reformer pilates exercise
• Control group
  intervention waiting group
  Intervention: Other: Reformer pilates exercise

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: June 27, 2023): 44
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 30, 2023
• Estimated Primary Completion Date: August 30, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 44 sedentary women aged 25-50 years without regular exercise habits

Exclusion Criteria:

• Individuals who cannot participate to the exercise program regularly,
• those with a serious musculoskeletal or neurological history,
• individuals with communication and emotional problems

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Healthy Sedentary women

• Ages: 25 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05932004
• Other Study ID Numbers: E-59394181-604.01.02-22602
• 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: Not Provided
• Current Responsible Party: Atılım University
• Original Responsible Party: Same as current
• Current Study Sponsor: Atılım University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Atılım University
• Verification Date: June 2023