Investigation of Respiratory Muscle Sarcopenia in Adults Diagnosed With Diabetes

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorKirsehir Ahi Evran Universitesi

About this trial

The aim of this study was to investigate respiratory muscle sarcopenia in individuals with diabet. The main question it aims to answer is:

What is the prevalence of respiratory muscle sarcopenia in patients with diabet? Participants body composition (bioelectrical impedance), hand grip strength (hand dynanometer), physical performance tests (5 repetition sit-and-stand test, 4-meter walk test, 6 minute walk test, Timed up-and-go test) and respiratory muscle strength were evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18-65

Diagnosed with Type 2 Diabetes mellitus

Being clinically stable

Ability to adapt to tests (visual, cognitive, cooperative)

Disqualifiers

Those with neurological and/or musculoskeletal problems that may affect the study

Presence of severe joint contracture or painful ulcers that may affect muscle strength measurement and walking

Presence of serious infection or sepsis

Having a known additional rheumatological disease diagnosis

Trial population

The sample size was calculated using G\*Power Software (ver. 3.1.3.2). A similar study in the literature was taken as a basis. The measurement values of the similar study were used to calculate the effect size (Effect size (d) = 0.12). Accordingly, the sample size of the study was found to be 84 participants with a 5% margin of error and 80% power.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

85 Participants
are grouped into 1 trial group
Group A: Adults with Diabetes

Trial outcomes

Primary outcomes

1

Respiratory Muscle Sarcopenia Assessment

The diagnosis of respiratory muscle sarcopenia will also be made by combining the results of secondary measurements. Participants included in the study: Hand grip strength \<27 kg for men and \<16 kg for women, Bioelectrical Impedance Analysis (Skeletal muscle mass (SMM) \<20 kg for men and \<15 kg for women) the participant is diagnosed with sarcopenia. They will also be diagnosed with a frailty phenotype based on the results of the Timed Stand and Walk Test, the 4 meter walk test and the 5 Repetition Sit and Stand Test. Patients diagnosed with sarcopenia will be diagnosed with respiratory muscle sarcopenia if respiratory muscle weakness is also detected.

Time frame
Baseline

Secondary outcomes

1

Body composition

Body mass and body composition will be measured using bioelectrical impedance method. The variables to be assessed are body mass index (BMI = body mass (kg)/height2 (m)2 ), fat mass (pFM) expressed as a percentage of body mass, fat-free mass (FFM) expressed in kilograms, and appendicular skeletal muscle mass (ASMM) and skeletal muscle mass (SMM) expressed in kilograms. Data will be collected with a bioelectrical impedance device and recorded on pre-prepared forms. The measurement will be made with a Tanita brand device. All measurement results will be obtained from the measurement report given by the device.

Time frame
baseline
2

Grip Force Measurement

The hand muscle grip strength of the individuals will be measured with a hand dynamometer. During the measurement, the position recommended by the American Association of Hand Therapists (ASHT); the participant will be in an upright sitting position and no arm support will be allowed on the sitting surface. The elbow and knee angle will be set to 90°. The wrist will be held without deviation. The measurement will be performed 3 times with an interval of 10 seconds and the highest value will be used in the study.

Time frame
baseline
3

5 Repetition Sit and Stand Test

An armless chair with a straight back support and a rigid seat at a height of 48 cm from the floor will be fixed to the wall. Participants will be asked to sit on the chair and come forward in the chair until their feet are flat on the floor. Participants will be asked to do a "stand and sit" movement once with their arms crossed across their chest. The test will be terminated for those who cannot complete the task or need assistance. Those who successfully complete the first task will be asked to perform five consecutive stand and sit as fast as possible. The timing is started with the command start and stopped at the end of the fifth posture. Our participants test scores will be recorded in seconds using a stopwatch.

Time frame
baseline
4

4 Meter Walking Speed Test (4MWT)

4MWT is a measure of walking speed, a vital sign of mobility and functionality. In older adults, walking speed is a clinical indicator of conditions such as frailty and sarcopenia. Participants were instructed to start walking at their normal speed 2 m behind the "start point" and continue until they passed the "end point". Using a stopwatch, the time taken for each participant to walk the 4 m distance between the "start" and "end" point will be measured. This will be used to calculate walking speed (distance/time).

Time frame
baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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