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The Effects of Strength Training on Muscle Mass and Mental Health in Adults Taking Obesity Medication (STRONG)

21 juni 2026 uppdaterad av: Jiyeon Yoon, University of Pittsburgh

The Effects of Strength Training on Muscle Mass and Mental Health in Adults Taking Obesity Medication: A Pilot Study

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

• 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.

Studietyp

Interventionell

Inskrivning (Beräknad)

40

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Jiyeon Yoon, M.S.
  • Telefonnummer: 512-817-4601
  • E-post: jiy239@pitt.edu

Studieorter

  • Förenta staterna
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Förenta staterna, 15219
        • Rekrytering
        • Physical Activity Research Center, University of Pittsburgh
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Resistance Exercise (RE)
Participants will perform 60 min of resistance exercise 2 sessions per week for 12 weeks while continuing GLP-1 RAs therapy as prescribed by regular treating provider
Beteende: Resistance Exercise
60 min/session, all for 2 sessions/week for 12 weeks
Läkemedel: GLP-1 RAs
Participants will take GLP-1 RAs for 12 weeks
Aktiv komparator: Standard Care
Participants will take GLP-1 RAs for 12 weeks as prescribed by regular treating provider
Läkemedel: GLP-1 RAs
Participants will take GLP-1 RAs for 12 weeks

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Body Composition
Tidsram: 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.
From Baseline to Week 12
Change in Quality of Life
Tidsram: 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.
From Baseline to Week 12

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Muscle Strength
Tidsram: 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.
From Baseline to Week 12
Energy Intake
Tidsram: From Baseline to Week 12
Energy intake will be assessed using the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.
From Baseline to Week 12
Physical Activity and Sleep
Tidsram: 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.
From Baseline to Week 12

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cardiovascular Fitness
Tidsram: From Baseline to Week 12
Cardiovascular fitness will be assessed using a submaximal treadmill test with the Balke-Ware protocol.
From Baseline to Week 12

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Pittsburgh

Samarbetspartners

University of Pittsburgh Medical Center

Utredare

  • Huvudutredare: Jiyeon Yoon, M.S., University of Pittsburgh

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

25 maj 2026

Primärt slutförande (Beräknad)

30 april 2027

Avslutad studie (Beräknad)

31 maj 2027

Studieregistreringsdatum

Först inskickad

11 januari 2026

Först inskickad som uppfyllde QC-kriterierna

10 juni 2026

Första postat (Faktisk)

17 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • STUDY25090068

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Datasets will be available to outside researchers and public health professionals through the web sites of ClinicalTrials.gov and The Physical Activity Research Center (PARC) at the University of Pittsburgh. Outside researchers can learn what data are available and request a de-identified dataset (stripped of all personal health identifiers). All data requests will be discussed with the research team and approval will be obtained from the institutional review board overseeing the proposal of the data analysis project. Findings from the proposed study will also be published in peer-reviewed journals. The investigators seek to maximize the knowledge generated from this study by sharing data to expedite the translation of research into practice, with the goal of preserving lean body mass and improving quality of life.

IPD-delning som stöder informationstyp

  • ICF

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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