Obesity, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities, Sarcopenia
Conditions
Keywords
exercise, physical activity, muscle, physical function
Brief summary
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.
Detailed description
Pharmacologically induced weight loss with glucagon-like peptide-1 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP) receptor agonists such as tirzepatide is associated with significant reductions in lean body mass, raising concerns regarding muscle function and long-term outcomes. Resistance exercise is the most effective intervention to preserve muscle mass during weight loss; however, evidence combining these approaches is limited. This study is a prospective, two-center, single-blinded, randomized controlled trial designed to evaluate whether structured resistance exercise enhances muscle preservation and functional outcomes in individuals receiving tirzepatide therapy.
Interventions
OTHERResistance exercise
A 24-week home-based resistance exercises using elastic band and bodyweight
Lifestyle recommendations including physical activity and nutritional advice
Sponsors
Acibadem University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes Assessor, Data Analyst
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * history of upper or lower extremity surgery or injury within the past 6 months * any contraindication to resistance exercise as determined by the treating physician.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in muscle thickness | Baseline, 12 weeks, 24 weeks | Muscle thickness of the thigh (quadriceps femoris) will be assessed using a portable ultrasound and will be presented in millimeters (mm). |
| Muscle echo intensity | Baseline, 12 weeks, 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle strength (handheld dynamometer) | Baseline, 12 weeks, 24 weeks | 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 | Baseline, 12 weeks, 24 weeks | Body weight will be assessed using bioelectrical impedance analysis and presented in kilograms (kg). |
| Six-minute walk test | Baseline, 12 weeks, 24 weeks | 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 | Baseline, 12 weeks, 24 weeks | 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. |
| Nutritional status (3-day food record) | Baseline, 12 weeks, 24 weeks | Dietary intake will be assessed at baseline, 12 weeks, and 24 weeks using 3-day food records (two non-consecutive weekdays and one weekend day). Prior to assessment, participants will receive standardized verbal, written, and visual instructions - including portion size estimation aids - to ensure accurate and consistent recording. |
| Quality of life (Short Form-36) | Baseline, 12 weeks, 24 weeks | The Short Form-36, a validated and reliable self-reported instrument evaluating physical and mental health status across eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health will be used to determine the level of quality of life. Physical and mental sub scales are scored from 0 to 100, higher scores indicate a better quality of life. |
| Clinical parameters (blood pressure) | Baseline, 12 weeks, 24 weeks | Blood pressure will be measured using a sphygmomanometer at each assessment point. |
| Height | Baseline, 12 weeks, 24 weeks | Height of the participants will be assessed using a stadiometer and presented in meters. |
| Body mass index | Baseline, 12 weeks, 24 weeks | Body mass index will be calculated using height and weight (kg/m\^2) |
| Body fat percentage | Baseline, 12 weeks, 24 weeks | Body fat percentage will be assessed using bioelectrical impedance analysis and presented in percentage (%). |
| Fat free mass | Baseline, 12 weeks, 24 weeks | Fat-free mass will be assessed using bioelectrical impedance analysis and presented in kilograms. |
| Chair stand test | Baseline, 12 weeks, 24 weeks | Functional capacity will be assessed using 30-second chair stand test according to standardized procedures. The number of repetitions which the participants fully raised from a chair will be recorded in numbers (n). |
| Self-reported physical activity | Baseline, 12 weeks, 24 weeks | Self-reported physical activity will be determined using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). Metabolic equivalent (MET) values will be calculated and participants will be categorized into inactive, moderately active, and very active based on MET values. |
| Grip strength | Baseline, 12 weeks, 24 weeks | Handgrip strength will be assessed using a JAMAR dynamometer (Sammons Preston, USA) following the standardized protocol. Three maximal isometric contractions will be performed with 1-minute rest intervals, the mean of the three trials in kilograms will be used for analysis. |
| Clinical measures (fasting glucose) | Baseline, 12 weeks, 24 weeks | Fasting glucose will be recorded from the medical records and will be presented in mmol/L. |
| Clinical parameters (lipid profile) | Baseline, 12 weeks, 24 weeks | Total Cholesterol, LDL (Low-Density Lipoprotein) Cholesterol, HDL (High-Density Lipoprotein) Cholesterol, Triglycerides will be recorded from the medical records and presented in mmol/L. |
| Muscle thickness | Baseline, 12 weeks, 24 weeks | Muscle thickness of the biceps femoris, triceps brachii, and biceps brachia will be assessed using a portable ultrasound and will be presented in millimeters (mm). |
| Muscle echo intensity | Baseline, 12 weeks, 24 weeks | 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 biceps femoris, biceps brachii, and triceps brachii. |
Contacts
CONTACTÖzgül Öztürk, Associate Professor
Outcome results
None listed