The Effect of Body Weight on Physical Activity Level, Functional Capacity, Balance, and Quality of Life in Individuals With Type 2 Diabetes Mellitus

Recruiting

• Conditions: Type 2 Diabetes Mellitus (T2DM); Body Mass Index; Functional Capacity; Balance

• Registration Number: NCT07152509
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

This study aims to investigate the effects of body weight on physical activity level, functional capacity, balance, and quality of life in patients with type 2 diabetes mellitus (T2DM). A total of 50 volunteer patients who meet the inclusion criteria will be recruited from the Internal Medicine and Nutrition outpatient clinics of Bezmialem Vakıf University Hospital.

Participants will be prospectively evaluated through face-to-face interviews. Assessments will include body composition analysis (Omron Body Composition Monitor), waist-to-hip ratio, lower extremity muscle strength (Muscle Hand-Held Dynamometer), grip strength (Hand Grip Dynamometer), physical activity level (International Physical Activity Questionnaire-Short Form), functional capacity (6-Minute Walk Test), balance (Biodex Balance System), clinical balance (Berg Balance Scale), and quality of life (Nottingham Health Profile).

All statistical analyses will be performed using IBM SPSS Statistics 20. With this study, we aim to comprehensively evaluate multiple parameters in individuals with T2DM and investigate their interrelationships, thereby contributing to the current body of knowledge in the literature.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-15
• Study First Submitted: 2025-08-26
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-03
• Primary Completion: 2025-10-15
• Study Completion: 2025-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Having a diagnosis of Type 2 Diabetes Mellitus for at least 1 year
• Being between 18 and 65 years of age
• Having an HbA1c value between 6.5% and 11% at the time of diagnosis
• No cognitive or mental problems
• Ability to walk independently
• Willingness to participate in the study

Exclusion Criteria

• Presence of uncontrolled cardiovascular and pulmonary disease
• Presence of vertigo or various vestibular system disorders
• Presence of severe neurological or respiratory disease
• History of stroke or myocardial infarction
• Presence of a major musculoskeletal problem
• Presence of chronic renal failure
• Presence of diabetic ulcer or neuropathy
• Pregnancy
• Presence of hemolytic or renal anemia
• Presence of serious visual, hearing, or speech impairments leading to lack of cooperation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional capacity	At baseline (single assessment)	Functional capacity will be evaluated using the 6-minute walk test (6MWT). At the beginning and end of the test, participants' oxygen saturation, heart rate, blood pressure, Borg dyspnea, and fatigue scores will be recorded. The test will be conducted in a 30-meter straight corridor, marked at 10-meter intervals, with chairs placed at both the starting and finishing points. Participants will be instructed to walk for 6 minutes at the fastest pace they can manage without running. To estimate the expected 6MWT distance, the reference equation by Enright et al. will be used in this study.
Assessment of Quality of Life Using the Nottingham Health Profile	At baseline (single assessment)	To evaluate patients' quality of life, the Nottingham Health Profile (NHP) will be used. The scale consists of six subdomains: pain, emotional reactions, sleep, social isolation, physical mobility, and energy. Within each subdomain, a score of 0 indicates the best quality of life, while a score of 100 indicates the worst quality of life.

Secondary Outcome Measures

Name	Time	Method
Body Composition	At baseline (single assessment)	For body composition analysis, the body mass index (BMI) of the participants (Body weight/height²) will be calculated. Using the Omron BF511 Body Composition Monitor (Omron Healthcare Co. Ltd; Japan), body fat percentage (%), skeletal m
waist-to-hip ratio	At baseline (single assessment)	Waist circumference will be measured in the standing position at the level of the umbilicus during the expiratory phase using a tape measure, and recorded in centimeters ("cm"). Hip circumference will be measured in the same position at the level of the greater trochanter and recorded in centimeters ("cm"). The waist-to-hip ratio will then be calculated.
Lower Extremity Muscle Strength Assessment	At baseline (single assessment)	Measurement of lower extremity muscle strength will be performed in a seated position, with the dominant leg in full knee extension, by applying maximum resistance using a handheld electronic dynamometer placed just above the ankle joint. The assessment will be conducted on the quadriceps muscle group using a handheld electronic dynamometer (Commander Muscle Tester; JTECH Medical, USA) and recorded in Newtons (N).
Handgrip Strength	At baseline (single assessment)	Handgrip strength will be measured on the dominant side using a Jamar hand dynamometer and recorded in pounds (lb). The test will be performed while the patients are seated comfortably on a chair, with the shoulder in adduction and neutral position, the elbow at 90° flexion, and the forearm and wrist in a neutral position.
Physical Activity Assessment	At baseline (single assessment)	Participants' physical activity levels will be evaluated using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). The IPAQ short form consists of seven questions designed to determine, on a daily basis over the past seven days, the time spent in vigorous physical activity (VPA), moderate physical activity (MPA), walking (W), and sitting (sedentary time). To calculate the total physical activity score, the weekly duration (minutes) of each activity is multiplied by the Metabolic Equivalent of Task (MET) values established for the IPAQ, and the resulting scores are obtained. The Turkish validity and reliability study of the IPAQ-Short Form was conducted by Sağlam M. et al.
Assessment of Functional Balance	At baseline (single assessment)	Patients' functional balance levels will be evaluated using the Turkish version of the Berg Balance Scale (BBS). This scale consists of tasks commonly used in daily life, such as static sitting, standing balance, transfers, turning, and picking up an object from the floor. Each item is scored on a scale from 0 (unable to perform the task) to 4 (normal performance).
Postural stability assessment	At baseline (single assessment)	Postural stability assessment will be performed using the Biodex Balance System (BBS) (Biodex Medical System, Inc; USA), including the Postural Stability Test for static postural stability and the Limits of Stability Test. The postural stability test evaluates the patient's ability to maintain their center of balance, and deviations from the center are recorded. The limits of stability test assesses the ability to move and control the center of gravity within the base of support. A higher score indicates a higher level of control.

Trial Locations

Locations (1)

Bezmialem Vakif University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation; Istanbul, Turkey (Türkiye)