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

NCT06004427 | Completed

• 1 other identifier: Uskudar74
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

resistant exercise; diet

Outcome Measures

Primary Outcomes (3)

• The Pittsburgh Sleep Quality Index (PSQI)

  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)

  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

  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

Study Arms (2)

control group

ACTIVE COMPARATOR

regular diet program

Other: Diet program

exercise group

EXPERIMENTAL

resistance exercise program

Other: Diet program; Other: Exercise training protocols

Interventions

Diet program OTHER

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.

control group; exercise group

Exercise training protocols OTHER

calisthenic exercises exercises with lower and upper extremity theraband exercises with light dumbbells

exercise group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Üsküdar Unıversıty

Üsküdar, Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• Waters DL, Aguirre L, Gurney B, Sinacore DR, Fowler K, Gregori G, Armamento-Villareal R, Qualls C, Villareal DT. Effect of Aerobic or Resistance Exercise, or Both, on Intermuscular and Visceral Fat and Physical and Metabolic Function in Older Adults With Obesity While Dieting. J Gerontol A Biol Sci Med Sci. 2022 Jan 7;77(1):131-139. doi: 10.1093/gerona/glab111.

  PMID: 33839788 BACKGROUND

• Dieli-Conwright CM, Courneya KS, Demark-Wahnefried W, Sami N, Lee K, Sweeney FC, Stewart C, Buchanan TA, Spicer D, Tripathy D, Bernstein L, Mortimer JE. Aerobic and resistance exercise improves physical fitness, bone health, and quality of life in overweight and obese breast cancer survivors: a randomized controlled trial. Breast Cancer Res. 2018 Oct 19;20(1):124. doi: 10.1186/s13058-018-1051-6.

  PMID: 30340503 BACKGROUND

• Soriano-Maldonado A, Martinez-Forte S, Ferrer-Marquez M, Martinez-Rosales E, Hernandez-Martinez A, Carretero-Ruiz A, Villa-Gonzalez E, Barranco-Ruiz Y, Rodriguez-Perez MA, Torrente-Sanchez MJ, Carmona-Rodriguez L, Soriano-Maldonado P, Vargas-Hitos JA, Casimiro-Andujar AJ, Artero EG, Fernandez-Alonso AM. Physical Exercise following bariatric surgery in women with Morbid obesity: Study protocol clinical trial (SPIRIT compliant). Medicine (Baltimore). 2020 Mar;99(12):e19427. doi: 10.1097/MD.0000000000019427.

  PMID: 32195937 BACKGROUND

• Villareal DT, Aguirre L, Gurney AB, Waters DL, Sinacore DR, Colombo E, Armamento-Villareal R, Qualls C. Aerobic or Resistance Exercise, or Both, in Dieting Obese Older Adults. N Engl J Med. 2017 May 18;376(20):1943-1955. doi: 10.1056/NEJMoa1616338.

  PMID: 28514618 BACKGROUND

• Willis LH, Slentz CA, Bateman LA, Shields AT, Piner LW, Bales CW, Houmard JA, Kraus WE. Effects of aerobic and/or resistance training on body mass and fat mass in overweight or obese adults. J Appl Physiol (1985). 2012 Dec 15;113(12):1831-7. doi: 10.1152/japplphysiol.01370.2011. Epub 2012 Sep 27.

  PMID: 23019316 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alara Livanur ÇELİK

  Uskudar University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: resistance training (RT), (3 days/wk, 3 sets/day, 8-12 repetitions/set)

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 22, 2023
• Study Start: September 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 20, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Locations

TU (1)