Investigation of the Effectiveness of Resistance Exercise Program Given With Diet in Obese Individuals.

December 21, 2023 updated by: Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
The aim of this study is to examine the effects of diet and combined resistance exercise training on physical activity and sleep patterns compared to diet program alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was planned as a randomized controlled trial. The groups will be divided into two as control group and exercise group by simple randomization method.While the normal diet program will be applied to the obese individuals in the control group, the individuals in the exercise group will be given resistance exercise training together with the diet program.Before and after the treatment, fatigue severity scale pittsburgh sleep quality scale international physical activity index questionnaires will be applied to the participants.In addition, sociodemographic characteristics and waist circumference measurement will be recorded. After the 12-week diet program, the data of the participants will be compared by making statistical analysis.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • İstanbul
      • Üsküdar, İstanbul, Turkey
        • Üsküdar Unıversıty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • be 18 years or older.
  • Having a Body Mass Index of 30 or higher.
  • To have accepted the voluntary consent form that requires participation in the study.

Exclusion Criteria:

  • Any neurological or psychological problems.
  • Do not accept the voluntary consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
regular diet program
Other: Diet program
A diet program will be prepared with the help of a dietitian at the beginning of 12 weeks for all participants who agree to participate in the study, and this program will be controlled by a dietitian once a month and completed at the end of 12 weeks.
Experimental: exercise group
resistance exercise program
Other: Diet program
A diet program will be prepared with the help of a dietitian at the beginning of 12 weeks for all participants who agree to participate in the study, and this program will be controlled by a dietitian once a month and completed at the end of 12 weeks.
Other: Exercise training protocols
calisthenic exercises exercises with lower and upper extremity theraband exercises with light dumbbells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 13 weeks
The scale is a 19-item self-report scale that assesses sleep quality and impairment over the past month. It consists of 24 questions, 19 questions are self-report questions, 5 questions are questions to be answered by the spouse or roommate. The 18 scored questions of the scale consist of 7 components. Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disorder, Sleeping Drug Use, and Daytime Dysfunction. Each component is evaluated over 0-3 points. The total score of the 7 components gives the scale total score. The total score ranges from 0 to 21. A total score greater than 5 indicates "poor sleep quality"
13 weeks
Fatigue Severity Scale (FSS)
Time Frame: 13 weeks
There are 9 questions in the scale and each question consists of 7 points. The scale determines the fatigue status of individuals in the last 1 month. Questions are scored as Strongly disagree - Totally agree. The scale score is the average value of the questions. If the average score is 5 and above, it is considered as "fatigue".
13 weeks
International Physical Activity Questionnaire - Short Form
Time Frame: 13 weeks
This questionnaire is a standardized tool for measuring physical activity, developed by researchers from various countries with the support of the World Health Organization (WHO) and Centers for Disease Control (CDC). Questionnaire, four areas of physical activity; It covers work, transportation, housework/gardening, and leisure activities, but also includes questions about time spent sitting as an indicator of inactivity. In each of the four areas, the energy expended in moderate and vigorous activities in the last 7 days, the number of days the activities were performed, and the number of activities performed during the day are recorded. The times are multiplied by the Metabolic Equivalent (MET) values per activity, and the results for all items are added to form the overall physical activity score. The question about sitting is not included in the physical activity score. Classification is made in three categories as physically inactive (3000 MET min/week).
13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uskudar University

Investigators

  • Study Chair: Alara Livanur ÇELİK, Uskudar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

December 20, 2023

Study Registration Dates

First Submitted

August 15, 2023

First Submitted That Met QC Criteria

August 16, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Uskudar74

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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