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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorBezmialem Vakif University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

  • Observational Assessment

    Other intervention

    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)

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Type 2 Diabetes Mellitus Group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At baseline (single assessment)
2

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.

Time frame
At baseline (single assessment)

Secondary outcomes

1

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

Time frame
At baseline (single assessment)
2

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.

Time frame
At baseline (single assessment)
3

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).

Time frame
At baseline (single assessment)
4

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.

Time frame
At baseline (single assessment)

Other outcomes

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