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

2026年6月21日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

• 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.

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Jiyeon Yoon, M.S.
  • 电话号码：512-817-4601
  • 邮箱：jiy239@pitt.edu

学习地点

  • 美国
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15219
        • 招聘中
        • Physical Activity Research Center, University of Pittsburgh
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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
行为的：Resistance Exercise
60 min/session, all for 2 sessions/week for 12 weeks
药品：GLP-1 RAs
Participants will take GLP-1 RAs for 12 weeks
有源比较器：Standard Care
Participants will take GLP-1 RAs for 12 weeks as prescribed by regular treating provider
药品：GLP-1 RAs
Participants will take GLP-1 RAs for 12 weeks

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Body Composition
大体时间：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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Muscle Strength
大体时间：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
大体时间：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
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
Cardiovascular Fitness
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Pittsburgh

合作者

University of Pittsburgh Medical Center

调查人员

  • 首席研究员：Jiyeon Yoon, M.S.、University of Pittsburgh

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月25日

初级完成 (估计的)

2027年4月30日

研究完成 (估计的)

2027年5月31日

研究注册日期

首次提交

2026年1月11日

首先提交符合 QC 标准的

2026年6月10日

首次发布 (实际的)

2026年6月17日

研究记录更新

最后更新发布 (实际的)

2026年6月24日

上次提交的符合 QC 标准的更新

2026年6月21日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • STUDY25090068

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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 共享支持信息类型

  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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