This randomized controlled trial aims to investigate the effects of a 24-week home-based progressive resistance exercise program combined with tirzepatide treatment on skeletal muscle mass, muscle quality, and functional capacity in overweight and obese individuals. A total of 108 participants initiating tirzepatide therapy will be randomized to either exercise plus pharmacotherapy or pharmacotherapy alone. The primary outcome is change in thigh muscle thickness and echo intensity assessed by ultrasonography.
initiation of tirzepatide-based pharmacological treatment as prescribed by an endocrinology and metabolism specialist,
body mass index (BMI) ≥27 kg/m² and the presence of a comorbidity condition or BMI≥30 kg/m²
age between 18 and 65 years
diagnosis of type 1 or type 2 diabetes mellitus
presence of cerebrovascular, hematological, pulmonary, rheumatological, or neurological disorders
current participation in a structured diet or exercise program
use of weight-loss medications within the past 12 months
Parallel
Resistance exercise
Other interventionA 24-week home-based resistance exercises using elastic band and bodyweight
Lifestyle recommendations
Other interventionLifestyle recommendations including physical activity and nutritional advice
Change in muscle thickness
Muscle thickness of the thigh (quadriceps femoris) will be assessed using a portable ultrasound and will be presented in millimeters (mm).
Muscle echo intensity
Echo intensity will be assessed via a portable muscle ultrasonography using grayscale analysis (0-255 scale) within a standardized region of interest using ImageJ software (National Institutes of Health, USA), with higher values indicating greater intramuscular fat and fibrous tissue infiltration and thus poorer muscle quality. Assessments will include quadriceps femoris.
Muscle strength (handheld dynamometer)
Isometric muscle strength of the biceps brachii, triceps brachii, quadriceps femoris, and hamstrings will be assessed bilaterally using a Lafayette handheld dynamometer (Lafayette Instrument Company®, USA) using the make test method.
Body weight
Body weight will be assessed using bioelectrical impedance analysis and presented in kilograms (kg).
Six-minute walk test
Functional capacity will be assessed using the 6-minute walk test according to standardized procedures and the total distance will be recorded in meters.
Physical activity
Physical activity will be measured objectively using a wearable device (Garmin Vívosmart 5), time spent for light, moderate, and vigorous activity will be recorded for 7 days.
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