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

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.

Study Overview

• Status: Recruiting
• Conditions: Functional Capacity; Type 2 Diabetes Mellitus (T2DM); Body Mass Index; Balance
• Intervention / Treatment: Other: Observational Assessment

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: SULE TOPCU SAHIN, PhD (c); Phone Number: +90 5398566970; Email: fztsuletopcu@gmail.com

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34654
    • Recruiting
    • Bezmialem Vakif University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
    • Contact: ŞULE TOPÇU ŞAHİN, PhD(c); Phone Number: +90 5398566970; Email: fztsuletopcu@gmail.com
    • Principal Investigator: SEMİRAMİS ÖZYILMAZ, Assoc. Prof.
    • Sub-Investigator: ŞULE TOPÇU ŞAHİN, PhD (c)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18-65 years with a diagnosis of Type 2 Diabetes Mellitus for at least 1 year, attending the Internal Medicine and Diet outpatient clinics, who meet the inclusion criteria and voluntarily agree to participate

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Type 2 Diabetes Mellitus Group; Participants diagnosed with type 2 diabetes mellitus will be included. Participants will undergo comprehensive assessment including body composition, muscle strength, hand grip strength, physical activity level, functional capacity, balance, and quality of life. No interventional procedure will be applied; the study is observational and cross-sectional.

Other: Observational Assessment; The demographic, clinical, and personal characteristics of the individuals will be collected and recorded through a questionnaire. For all participants, body fat percentage (%), skeletal muscle mass percentage (%), visceral fat percentage (%), and resting metabolic rate (kcal), measured using the Omron Body Composition Monitor, will be recorded. Waist and hip circumference will be measured with a tape measure; lower extremity muscle strength (M. Quadriceps) will be assessed with a muscle hand-held dynamometer; grip strength will be assessed with a hand grip dynamometer; physical activity level will be evaluated using the International Physical Activity Questionnaire-Short Form (IPAQ-SF); functional capacity will be measured with the 6-Minute Walk Test (6MWT); postural stability and balance will be assessed with the Biodex Balance System; clinical balance will be assessed with the Berg Balance Scale; quality of life will be evaluated using the Nottingham Health Profile (NHP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity	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.	At baseline (single assessment)
Assessment of Quality of Life Using the Nottingham Health Profile	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.	At baseline (single assessment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Composition	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	At baseline (single assessment)
waist-to-hip ratio	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.	At baseline (single assessment)
Lower Extremity Muscle Strength 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).	At baseline (single assessment)
Handgrip Strength	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.	At baseline (single assessment)
Physical Activity 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.	At baseline (single assessment)
Assessment of Functional Balance	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).	At baseline (single assessment)
Postural stability 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.	At baseline (single assessment)

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Principal Investigator: SEMİRAMİS ÖZYILMAZ, Assoc. Prof., Bezmialem Vakıf University,Facult Of Health Sciences, Department Of Physiotherapy And Rehabilitation

Publications and helpful links

General Publications

• Rejeski WJ, Lang W, Neiberg RH, Van Dorsten B, Foster GD, Maciejewski ML, Rubin R, Williamson DF; Look AHEAD Research Group. Correlates of health-related quality of life in overweight and obese adults with type 2 diabetes. Obesity (Silver Spring). 2006 May;14(5):870-83. doi: 10.1038/oby.2006.101.
• Awotidebe TO, Adedoyin RA, Yusuf AO, Mbada CE, Opiyo R, Maseko FC. Comparative functional exercise capacity of patients with type 2-diabetes and healthy controls: a case control study. Pan Afr Med J. 2014 Nov 7;19:257. doi: 10.11604/pamj.2014.19.257.4798. eCollection 2014.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2025
• Primary Completion (Estimated): October 15, 2025
• Study Completion (Estimated): October 15, 2025

Study Registration Dates

• First Submitted: August 26, 2025
• First Submitted That Met QC Criteria: August 26, 2025
• First Posted (Estimated): September 3, 2025

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: physical activity; quality of life; body mass index; type 2 diabetes mellitus
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Behavior; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Motor Activity
• Other Study ID Numbers: BezmialemUNV2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The plan for IPD sharing has not yet been determined

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No