NCT03491566

Brief Summary

The aim of this study is to investigate the effectiveness of Pilates-based exercises on cognitive functions in comparison with aerobic exercises. Individuals in the 4-weeks study will be divided into two groups using the Graphpad website: Clinical Pilates exercise group (Group 1), aerobic exercise group (Group 2). The sample size for each group was calculated as 24 people. Considering the possibility of %10 drops, 27 individuals will be included in each group and a total of 54 cases in the study. First, the socio-demographic information of the participants will be collected with a prepared form. Individuals will be assessed by the International Physical Activity Questionnaire-Short Form, Nelson Speed of Movement Test, Verbal Fluency Test and Stroop Test at pre-study,end of the first session and end of the study (4th week). Participants in control will be given will keep an activity lo to check their physical activity levels. SPSS package programme will be used in the analysis of the data and p\<0.05 will be considered significant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2018

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 9, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2019

Completed
Last Updated

December 1, 2020

Status Verified

November 1, 2020

Enrollment Period

9 months

First QC Date

March 27, 2018

Last Update Submit

November 28, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cognitive Function: Selective Attention, Information Processing Speed

    Stroop test is one of the neuropsychological tests showing frontal lobe activity. It is used for evaluating information processing speed, interference effect and selective attention. In test, there are 4 cards. On the 1st card there are the names of the colors printed in black, on the 2nd card there are the names of the colors printed in red-blue-yellow-green, on the 3rd card there are circles of 0.4 cm in diameter printed in red, blue, yellow, green, on the 4th card there are "and, over, hard, when " words printed in red-blue-yellow-green.The test's basic scores are obtained by scoring the sections separately. Total score of test is obtained by the total time from the command "Start" to the reading of the last item of the card, the number of errors and the number of correction in subject' reaction.

    1 month

Secondary Outcomes (2)

  • Hemispheric Cognitive Function

    1 month

  • Speed of Movement

    1 month

Study Arms (2)

Clinic Pilates Group

EXPERIMENTAL

Initial assessments of participants were made and they were taught key components of the Clinical Pilates exercises. Exercises were administered for 4 weeks, 3 days/week, 40-50 minutes/session under the supervision of a physiotherapist. Groups of 9-10 people with similar physical characteristics and fitness level for session times were created. The sessions were started with level 1 exercises requiring more support and less control. Each exercise was repeated 8-10 times; as the physical level of the participants increased, exercises progressed towards level 3 exercises requiring more attention, concentration and control. Each session consisted of an average of 10 minutes warm-up, 20 to 30 minutes of matt and 10 minutes cooling of of Clinical Pilates exercises.

Other: Clinic Pilates Group

Aerobic Exercise Group

EXPERIMENTAL

Initial assessments of participants were made before the first session. Using an elliptical bicycle or bicycle, or treadmill under the supervision of a physiotherapist, a total of 150 minutes moderate intensity (50-70% of maximal heart rate (HRmax)) aerobic exercise in accordance with the World Health Organization's guideline was applied, 3 days/week (50 mins/session) or 5 days/week (30 mins /session) for 4 weeks. The instruments to be used for the exercises were chosen according to the preference of the individual. HRmax was calculated using the "220-years". For example; at the age of 20 years, the target heart rate was determined as 100-140 beats/min for moderate physical activity in a person with HRmax 200 beats/min.

Other: Aerobic Exercise Group

Interventions

Clinical Pilates exercises include "Hundreds", "One Leg Stretch", "Shoulder Bridge", "One Leg Kick", Swimming ", Double Leg Stretch", "Swan Dive" Circle "," Arm Opening "," Spine Twist "," Roll Down "exercises.

Clinic Pilates Group

Aerobic exercise with using an elliptical bike, or bike or treadmill under supervision of a physiotherapist.

Aerobic Exercise Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being a healthy individual between the ages of 18-25,
  • No problem with reading, writing or understanding Turkish,
  • According to International Physical Activity Questionnaire Short Form being physically inactive (\< 600 MET (metabolic equivalent of task)/mins),
  • Volunteering and sustainability to the study.

You may not qualify if:

  • Musculoskeletal system problems that prevent exercising,
  • Cardiovascular system disorders such as myocardial infarction, angina, exercise intolerance, uncontrolled hypertension, etc. that limit effort capacity,
  • Neurological disorder or cognitive dysfunction such as stroke, dementia, schizophrenia, etc.,
  • Pregnancy,
  • Smoking,
  • Achromatopsia,
  • Body Mass Index (BMI) higher \> 35,
  • Beck Depression Scale score ≥ 17.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

Study Officials

  • Ayse Zengin Alpozgen

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, Lecturer

Study Record Dates

First Submitted

March 27, 2018

First Posted

April 9, 2018

Study Start

March 1, 2018

Primary Completion

November 30, 2018

Study Completion

January 7, 2019

Last Updated

December 1, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations