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

NCT07152509 | Recruiting

• 1 other identifier: BezmialemUNV2025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

quality of life; type 2 diabetes mellitus; body mass index; physical activity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Body Composition

  At baseline (single assessment)

• waist-to-hip ratio

  At baseline (single assessment)

• Lower Extremity Muscle Strength Assessment

  At baseline (single assessment)

• Handgrip Strength

  At baseline (single assessment)

• Physical Activity Assessment

  At baseline (single assessment)

Study Arms (1)

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

Interventions

Observational Assessment OTHER

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)

Type 2 Diabetes Mellitus Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Istanbul, 34654, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 16855197 RESULT

• 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.

  PMID: 25852800 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• SEMİRAMİS ÖZYILMAZ, Assoc. Prof.

  Bezmialem Vakıf University,Facult Of Health Sciences, Department Of Physiotherapy And Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ŞULE TOPÇU ŞAHİN, PhD (c)

CONTACT

+90 5398566970; fztsuletopcu@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: August 15, 2025
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

TU (1)