[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07652333":3,"trial-entities:NCT07652333":135,"trial-summary:NCT07652333":138},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":43,"secondary_outcomes":51,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":15,"eligibility_criteria":64,"std_ages":92,"locations":95,"central_contacts":111,"overall_officials":114,"references":117,"see_also_links":118},"NCT07652333","STUDY25090068","The Effects of Strength Training on Muscle Mass and Mental Health in Adults Taking Obesity Medication","The Effects of Strength Training on Muscle Mass and Mental Health in Adults Taking Obesity Medication: A Pilot Study","RECRUITING","2027-05-31","2026-06","2026-06-24","2026-05-25","University of Pittsburgh","OTHER",false,"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.\n\n•The duration of this study is 3 months. This includes:\n\n* Orientation session to explain study protocol, exercise program, and complete questionnaire about participants' medical history and lifestyle.\n* 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.\n* Personalized resistance exercise sessions for 60 minutes per session, twice per week, for 3 months.","• 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:\n\n1. 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\u002Fsession, all for 2 sessions\u002Fweek for 3 months. Participants may follow their provider's guidance for exercise except not to perform any strength or resistance training.\n2. Resistance exercise group: 60 min\u002Fsession, all for 2 sessions\u002Fweek for 3 months.\n\n   * Resistance exercise group (60 min\u002Fsession): 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.\n\nInvestigator 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.",[19,20,21],"Muscle Composition","Obesity","Quality of Life (QOL)",[],"INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},40,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"BEHAVIORAL","Resistance Exercise","60 min\u002Fsession, all for 2 sessions\u002Fweek for 12 weeks",[36],"Resistance Exercise (RE)",{"type":38,"name":39,"description":40,"armGroupLabels":41},"DRUG","GLP-1 RAs","Participants will take GLP-1 RAs for 12 weeks",[36,42],"Standard Care",[44,48],{"measure":45,"description":46,"timeFrame":47},"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.","From Baseline to Week 12",{"measure":49,"description":50,"timeFrame":47},"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.",[52,55,58],{"measure":53,"description":54,"timeFrame":47},"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.",{"measure":56,"description":57,"timeFrame":47},"Energy Intake","Energy intake will be assessed using the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.",{"measure":59,"description":60,"timeFrame":47},"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.","ALL","18 Years",null,{"inclusion":65,"exclusion":72,"raw_text":91},[66,67,68,69,70,71],"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\u002Fm² 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",[73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90],"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\u002Fhyperthyroidism","Personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia Syndrome type 2 (MEN2)","Gastroparesis","Chronic\u002Fidiopathic acute pancreatitis","Hepatic disease or cirrhosis","Struggle with alcohol or other substance abuse (heavy drinking (≥4 drinks\u002Fday or ≥8 drinks\u002Fweek for women; ≥5 drinks\u002Fday or ≥15 drinks\u002Fweek 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","Inclusion Criteria:\n\n* Initiating GLP-1 RAs prescribed by physician or advanced practice practitioner and willing to withhold the start of the drug until baseline assessment completed\n* Non-Smoker\n* ≥18 years old\n* Obese: Body Mass Index 30-45 kg\u002Fm² or BMI ≥27 + ≥1 weight related comorbidity; either hypertension or sleep apnea confirmed by participant self-report\n* Inactive: not meeting the current US exercise guidelines over the past 6 months\n* Capable of performing the required exercise training\n\nExclusion Criteria:\n\n* 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\n* Cancer requiring treatment in the past 5 years\n* Hypothyroidism\u002Fhyperthyroidism\n* Personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia Syndrome type 2 (MEN2)\n* Gastroparesis\n* Chronic\u002Fidiopathic acute pancreatitis\n* Hepatic disease or cirrhosis\n* Struggle with alcohol or other substance abuse (heavy drinking (≥4 drinks\u002Fday or ≥8 drinks\u002Fweek for women; ≥5 drinks\u002Fday or ≥15 drinks\u002Fweek for men), or who score ≥3 on the Drug Abuse Screening Test (DAST-10))\n* Diabetes (Type 1 or 2)\n* Major risk factors for coronary heart disease such as uncontrolled high blood pressure (≥160 mm Hg systolic or ≥100 mm Hg diastolic)\n* Problems with your muscles or bones that limit your ability to exercise\n* Any other medical condition that is life-threatening, can interfere with or be aggravated by the exercise training\n* Plans to be away ≥2 weeks in the next 3 months\n* Participation in any other concurrent interventional clinical trial\n* 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\n* Inability to give informed consent\n* 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.)\n* Pregnant or plan to become pregnant during study",[93,94],"ADULT","OLDER_ADULT",[96],{"facility":97,"status":8,"city":98,"state":99,"zip":100,"country":101,"contacts":102,"geoPoint":108},"Physical Activity Research Center, University of Pittsburgh","Pittsburgh","Pennsylvania","15219","United States",[103],{"name":104,"role":105,"phone":106,"email":107},"Jiyeon Yoon, M.S.","CONTACT","515-817-4601","jiy239@pitt.edu",{"lat":109,"lon":110},40.44062,-79.99589,[112],{"name":104,"role":105,"phone":113,"email":107},"512-817-4601",[115],{"name":104,"affiliation":13,"role":116},"PRINCIPAL_INVESTIGATOR",[],[119,122,125,128,130,132],{"label":120,"url":121},"Benefits of Exercise","https:\u002F\u002Fmedlineplus.gov\u002F",{"label":123,"url":124},"Exercise and Physical Fitness","https:\u002F\u002Fmedlineplus.gov\u002Fexerciseandphysicalfitness.html",{"label":126,"url":127},"Exercise for Older Adults","https:\u002F\u002Fmedlineplus.gov\u002Fexerciseforolderadults.html",{"label":39,"url":129},"https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002Fsearch.cfm?labeltype=human&query=Tirzepatide",{"label":20,"url":131},"https:\u002F\u002Fmedlineplus.gov\u002Fobesity.html",{"label":133,"url":134},"Weight Control","https:\u002F\u002Fmedlineplus.gov\u002Fweightcontrol.html",{"nct_id":4,"conditions":136,"biomarkers":137},[20],[],{"nct_id":4,"found":15,"summary":63,"prompt_version":63}]