The Effects of Strength Training on Muscle Mass and Mental Health in Adults Taking Obesity Medication (STRONG)
21 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
• 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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Jiyeon Yoon, M.S.
- Número de teléfono: 512-817-4601
- Correo electrónico: jiy239@pitt.edu
Ubicaciones de estudio
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15219
- Reclutamiento
- Physical Activity Research Center, University of Pittsburgh
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Contacto:
- Jiyeon Yoon, M.S.
- Número de teléfono: 515-817-4601
- Correo electrónico: jiy239@pitt.edu
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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
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60 min/session, all for 2 sessions/week for 12 weeks
Participants will take GLP-1 RAs for 12 weeks
|
|
Comparador activo: Standard Care
Participants will take GLP-1 RAs for 12 weeks as prescribed by regular treating provider
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Participants will take GLP-1 RAs for 12 weeks
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Body Composition
Periodo de tiempo: From Baseline to Week 12
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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
Periodo de tiempo: 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.
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From Baseline to Week 12
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Muscle Strength
Periodo de tiempo: 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
Periodo de tiempo: From Baseline to Week 12
|
Energy intake will be assessed using the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.
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From Baseline to Week 12
|
|
Physical Activity and Sleep
Periodo de tiempo: 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.
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From Baseline to Week 12
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cardiovascular Fitness
Periodo de tiempo: From Baseline to Week 12
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Cardiovascular fitness will be assessed using a submaximal treadmill test with the Balke-Ware protocol.
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From Baseline to Week 12
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jiyeon Yoon, M.S., University of Pittsburgh
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
25 de mayo de 2026
Finalización primaria (Estimado)
30 de abril de 2027
Finalización del estudio (Estimado)
31 de mayo de 2027
Fechas de registro del estudio
Enviado por primera vez
11 de enero de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de junio de 2026
Publicado por primera vez (Actual)
17 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Trastornos Nutricionales
- Sobrenutrición
- Peso corporal
- Exceso de peso
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Obesidad
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Terapéutica
- Modalidades de fisioterapia
- Atención al paciente
- Terapia de ejercicio
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Acondicionamiento físico, humano
- Ejercicio
- Entrenamiento de resistencia
Otros números de identificación del estudio
- STUDY25090068
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
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.
Tipo de información de apoyo para compartir IPD
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .