The Effects of Strength Training on Muscle Mass and Mental Health in Adults Taking Obesity Medication (STRONG)
10. juni 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
• 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:
- 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.
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
40
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jiyeon Yoon, M.S.
- Telefonnummer: 512-817-4601
- E-mail: jiy239@pitt.edu
Studiesteder
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15219
- Rekruttering
- Physical Activity Research Center, University of Pittsburgh
-
Kontakt:
- Jiyeon Yoon, M.S.
- Telefonnummer: 5158174601
- E-mail: jiy239@pitt.edu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
60 min/session, all for 2 sessions/week for 12 weeks
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
|
Participants will take GLP-1 RAs for 12 weeks
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Body Composition
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Muscle Strength
Tidsramme: 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.
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From Baseline to Week 12
|
|
Energy Intake
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cardiovascular Fitness
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jiyeon Yoon, M.S., University of Pittsburgh
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
25. maj 2026
Primær færdiggørelse (Anslået)
30. april 2027
Studieafslutning (Anslået)
31. maj 2027
Datoer for studieregistrering
Først indsendt
11. januar 2026
Først indsendt, der opfyldte QC-kriterier
10. juni 2026
Først opslået (Faktiske)
17. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Ernæringsforstyrrelser
- Overernæring
- Kropsvægt
- Overvægtig
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Fedme
- Motorisk aktivitet
- Bevægelse
- Muskuloskeletale fysiologiske fænomener
- Muskuloskeletale og neurale fysiologiske fænomener
- Terapeutik
- Fysioterapimodaliteter
- Patientpleje
- Træningsterapi
- Rehabilitering
- Efterpleje
- Kontinuitet i patientpleje
- Fysisk konditionering, menneske
- Øvelse
- Modstandstræning
Andre undersøgelses-id-numre
- STUDY25090068
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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-deling Understøttende informationstype
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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