The Effects of Strength Training on Muscle Mass and Mental Health in Adults Taking Obesity Medication (STRONG)
10. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
• 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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
40
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Jiyeon Yoon, M.S.
- Telefonnummer: 512-817-4601
- E-Mail: jiy239@pitt.edu
Studienorte
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Vereinigte Staaten, 15219
- Rekrutierung
- Physical Activity Research Center, University of Pittsburgh
-
Kontakt:
- Jiyeon Yoon, M.S.
- Telefonnummer: 5158174601
- E-Mail: jiy239@pitt.edu
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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
|
|
Aktiver 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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Body Composition
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Muscle Strength
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Cardiovascular Fitness
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Jiyeon Yoon, M.S., University of Pittsburgh
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
25. Mai 2026
Primärer Abschluss (Geschätzt)
30. April 2027
Studienabschluss (Geschätzt)
31. Mai 2027
Studienanmeldedaten
Zuerst eingereicht
11. Januar 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
10. Juni 2026
Zuerst gepostet (Tatsächlich)
17. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
17. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
10. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Ernährungsstörungen
- Überernährung
- Körpergewicht
- Übergewicht
- Pathologische Zustände, Anzeichen und Symptome
- Ernährungs- und Stoffwechselerkrankungen
- Anzeichen und Symptome
- Fettleibigkeit
- Motorik
- Bewegung
- Phänomen des Bewegungsapparates muskuloskelettal
- Muskuloskelettaler und neuronales physiologisches Phänomen
- Therapeutika
- Physiotherapiemodalitäten
- Patientenversorgung
- Trainingstherapie
- Rehabilitation
- Nachbehandlung
- Kontinuität der Patientenversorgung
- Körperliche Kondition, menschlich
- Übung
- Widerstandstraining
Andere Studien-ID-Nummern
- STUDY25090068
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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.
Art der unterstützenden IPD-Freigabeinformationen
- ICF
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .