Muscle Composition, Obesity, Quality of Life (QOL)
Conditions
Brief summary
The purpose of this study is to examine the effects of resistance exercise, such as weightlifting, on retention of muscle mass and mental health in individuals taking GLP-1 RAs (an obesity medication). Resistance exercise is focused on increasing the strength of participants' muscles, such as how much participant can lift. •The duration of this study is 3 months. This includes: * Orientation session to explain study protocol, exercise program, and complete questionnaire about participants' medical history and lifestyle. * Two health assessments at baseline and at 3 months. These assessments include body composition, resting blood pressure, cardiovascular function, and muscular strength. Both the resistance exercise group and the control group will complete assessments at baseline and again at 3 months. After the 3-month period, individuals in the control group may choose to participate in the exercise training and complete the optional 6-month assessments. * Personalized resistance exercise sessions for 60 minutes per session, twice per week, for 3 months.
Detailed description
• After the baseline assessment, if participants meet all eligibility criteria such as BMI, blood pressure, physical activity levels, and medication conditions, investigators will randomly assign participants to control group or resistance exercise group: 1. Control group: No resistance training during the first 3 months. After the 3-month period, participants may choose to participate in the optional exercise program, which includes 60 min/session, all for 2 sessions/week for 3 months. Participants may follow their provider's guidance for exercise except not to perform any strength or resistance training. 2. Resistance exercise group: 60 min/session, all for 2 sessions/week for 3 months. * Resistance exercise group (60 min/session): Each session will be 60 minutes of resistance, performing 3 sets of 8-20 repetitions (50-80% 1RM) of 11 exercises (chest press, lat pulldown, abdominal crunch, leg press, shoulder press, weighted row, leg extension, leg curl, chest fly, biceps curl, and triceps extension) using weight training machines. Investigator will also ask participants to maintain their usual (pre-study) lifestyle physical activity outside of exercise sessions and to monitor participants' daily activity throughout the study period using pedometers and a lifestyle activity log.
Interventions
BEHAVIORALResistance Exercise
60 min/session, all for 2 sessions/week for 12 weeks
DRUGGLP-1 RAs
Participants will take GLP-1 RAs for 12 weeks
Sponsors
University of Pittsburgh
University of Pittsburgh Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Initiating GLP-1 RAs prescribed by physician or advanced practice practitioner and willing to withhold the start of the drug until baseline assessment completed * Non-Smoker * ≥18 years old * Obese: Body Mass Index 30-45 kg/m² or BMI ≥27 + ≥1 weight related comorbidity; either hypertension or sleep apnea confirmed by participant self-report * Inactive: not meeting the current US exercise guidelines over the past 6 months * Capable of performing the required exercise training
Exclusion criteria
* A serious heart condition, such as unstable heart disease or heart failure, irregular heartbeats that are not well controlled, severe narrowing of the heart valves, or any recent inflammation of the heart or its lining * Cancer requiring treatment in the past 5 years * Hypothyroidism/hyperthyroidism * Personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia Syndrome type 2 (MEN2) * Gastroparesis * Chronic/idiopathic acute pancreatitis * Hepatic disease or cirrhosis * Struggle with alcohol or other substance abuse (heavy drinking (≥4 drinks/day or ≥8 drinks/week for women; ≥5 drinks/day or ≥15 drinks/week for men), or who score ≥3 on the Drug Abuse Screening Test (DAST-10)) * Diabetes (Type 1 or 2) * Major risk factors for coronary heart disease such as uncontrolled high blood pressure (≥160 mm Hg systolic or ≥100 mm Hg diastolic) * Problems with your muscles or bones that limit your ability to exercise * Any other medical condition that is life-threatening, can interfere with or be aggravated by the exercise training * Plans to be away ≥2 weeks in the next 3 months * Participation in any other concurrent interventional clinical trial * History of eating disorders or weight-loss surgery, unstable weight (±5% change in past 6 months), or use of obesity medication (e.g., such as Wegovy, Ozempic, Saxenda, Zepbound, Mounjaro) in the last 3 months * Inability to give informed consent * History of major depression or other severe psychiatric disorders (e.g., who answer "yes" to question 9 on PHQ-9 in the Psych\_QoL\_Sleep questionnaires.) * Pregnant or plan to become pregnant during study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Composition | From Baseline to Week 12 | Dual-energy X-ray absorptiometry (DEXA) will be used to assess fat mass and lean mass. Body fat will be expressed as a percentage of total body composition, and lean mass will be expressed as a percentage of total body composition. Change in each variable will be calculated as the Week 12 value minus the baseline value. Positive values indicate an increase in body fat or lean mass, and negative values indicate a decrease. |
| Change in Quality of Life | From Baseline to Week 12 | Quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). Scores range from 0 to 100, with higher scores indicating better quality of life. Change will be calculated as Week 12 minus baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Strength | From Baseline to Week 12 | Grip strength will be measured three times in each hand using a Jamar dynamometer, and one-repetition maximum (1RM) will be measured using leg press and chest press machines. |
| Energy Intake | From Baseline to Week 12 | Energy intake will be assessed using the Automated Self-Administered 24-hour (ASA24) dietary assessment tool. |
| Physical Activity and Sleep | From Baseline to Week 12 | Participants will be asked to wear a GENEActiv tri-axial wrist-worn accelerometer for a 7-day period to quantify physical activity and sedentary behavior. Participants will be instructed to wear the device continuously for 24 hours per day throughout the 7-day measurement period. |
Countries
United States
Contacts
CONTACTJiyeon Yoon, M.S.
PRINCIPAL_INVESTIGATORJiyeon Yoon, M.S.
University of Pittsburgh
Outcome results
None listed