The Effects of Strength Training on Muscle Mass and Mental Health in Adults Taking Obesity Medication
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Resistance Exercise
Behavioral60 min/session, all for 2 sessions/week for 12 weeks
GLP-1 RAs
DrugParticipants will take GLP-1 RAs for 12 weeks
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Resistance Exercise (RE)Experimental treatment 2 interventions
Group B: Standard CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Body Composition
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.
Time frame
From Baseline to Week 122
Change in Quality of Life
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.
Time frame
From Baseline to Week 12Secondary outcomes
1
Muscle Strength
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.
Time frame
From Baseline to Week 122
Energy Intake
Energy intake will be assessed using the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.
Time frame
From Baseline to Week 123
Physical Activity and Sleep
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.
Time frame
From Baseline to Week 12Other outcomes
1
Cardiovascular Fitness
Cardiovascular fitness will be assessed using a submaximal treadmill test with the Balke-Ware protocol.
Time frame
From Baseline to Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
University of Pittsburgh Medical Center
Collaborator
Source ClinicalTrials.gov