Clinical trial NCT05591794: Effects of Diet Versus Diet Plus Aerobic and Resistant Exercise Program in Overweight Women
Official title: Effects of an Eight-week Diet Versus Diet Plus Aerobic and Resistant Exercise Program on Postural Control, Musculoskeletal Disorders, Functional Capacity, and Sleep in Overweight Women: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Overweight
Exercise
Keywords: Overweight
Aerobic and resistance exercise
Postural control
Musculoskeletal disorders
Functional capacity
Sleep
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

Brief summary: Adult women aged 18-50 years and overweight (preobese) with a BMI of 25-30 kg/m2 will be included in the study. Participants will participate in an eight-week diet and diet plus aerobic and resistance exercise program. Patients will be referred from the Nutrition and Diet Polyclinic of Bezmialem Vakıf University to this study, which will be conducted to investigate the effects of exercise program on postural control, musculoskeletal system disorders, functional capacity, and sleep.

Detailed description: Subjects who accepted to participate in the study will be randomized and divided into two groups as study and control groups. A computer-based randomization program (random.org) will be used to determine the cases to be assigned to the study and control groups. 2 numbers consisting of 12 numbers will be determined by random selection from the numbers between 1 and 24. The first of these number sequences will be considered as the study group and the second as the control group. Each patient included in the study will be asked to draw one of the sealed envelopes in which the numbers 1 to 24 are written. The case will be assigned to the study or control group according to the number sequence in which the drawn number is included. While the women in the study group are expected to perform regular walking with a diet for eight weeks and a 3-day aerobic and resistance exercise program per week, the subjects in the control group will be followed up with diet and regular walking. Initially, participants will be educated on healthy eating habits through one-on-one dietitian consultation. A personalized calorie-restricting nutrition program will be given. According to this program, the daily energy intake of the individual will be reduced to provide 0.5-1.0 kg of body weight loss per week.

Eligibility criteria: Inclusion Criteria:

* BMI between 25-29.9kg/m2
* Being between the ages of 18-50
* Agreeing to participate voluntarily in the study

Exclusion Criteria:

* Pregnancy
* Presence of systemic disease that will prevent participation in an aerobic exercise program
* Presence of conditions such as pain or surgery that will prevent participation in an aerobic exercise program
* Participating in a regular exercise program within the last 1 year

Primary outcomes:
measure: Evaluation of postural control by Biodex Balance System
timeFrame: Change between baseline and 8-week scores of Biodex Balance System.
Secondary outcomes:
measure: Evaluation of musculoskeletal by Extended Nordic Musculoskeletal Questionnaire
timeFrame: Change between baseline and 8-week scores of Extended Nordic Musculoskeletal Questionnaire.
measure: Evaluation of functional capacity by 6 minute walk test
timeFrame: Change between baseline and 8-week scores of 6 Minute Walk Test.
measure: Evaluation of sleep quality by Pittsburgh Sleep Quality Index
timeFrame: Change between baseline and 8-week scores of Pittsburgh Sleep Quality Index.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Bezmialem Vakif University
name: Deniz Tuncer, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: