Functional, Cognitive, and Behavioral Correlates of Resistance Training During Tirzepatide-Induced Weight Loss (RESIST-MIND)
Functional, Cognitive, and Behavioral Correlates of Resistance Training During Tirzepatide-Induced Weight Loss in Adults With Obesity - An Ancillary Study to the RESIST Trial
This study is an ancillary study to the RESIST trial, in which adults with obesity receive the weight-loss medication tirzepatide and are randomly assigned to a structured resistance training program or to usual care for 24 weeks.
RESIST-MIND explores whether resistance training during tirzepatide treatment is associated with changes in attention and concentration, food-related thoughts ("food noise") and food craving, fatigue, sleep quality, everyday functioning, work ability, and motivation for exercise. It also explores whether preserving muscle mass and strength during weight loss is related to these changes. Participants complete questionnaires and a computer-based attention test at the start (Week 0) and at the end (Week 24) of the RESIST treatment period. No additional visits, interventions, or biological samples are part of this ancillary study.
研究概览
详细说明
RESIST-MIND is a prospective, observational, monocentric ancillary study conducted at the TUM Klinikum, Munich, Germany. Active participation in the RESIST trial (protocol code RESIST-26-HAL-0150-I; EU CT number 2026-526200-69-00) is a prerequisite for enrolment. RESIST is a randomized, controlled, open-label Phase IV trial evaluating a structured resistance training program versus usual care in 150 adults with obesity treated with tirzepatide (Mounjaro®) over 24 weeks. RESIST-MIND involves no investigational medicinal product, no intervention, and no randomization. Assignment to resistance training or usual care occurs exclusively within the RESIST trial.
RESIST-MIND adds validated self-administered questionnaires (MFI-20, PSQI, WHODAS 2.0 12-item, FNQ, FCQ-T-reduced, SSK scale; WAI and WPAI in working participants only) and the electronic d2-R Test of Attention at the RESIST baseline visit (V1, Week 0) and end-of-treatment visit (V7, Week 24). Muscle, strength, body composition, anthropometric and patient-reported data are obtained from the RESIST trial database. All endpoints are exploratory and equally ranked, defined as change from V1 to V7. Between-group differences (resistance training vs. usual care) are estimated using linear models adjusted for baseline. Associations between changes in body composition and changes in the ancillary endpoints are examined across both groups using correlation and multiple linear regression. No formal power calculation or multiplicity adjustment is performed.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Stephan Müller-Stegner, Dr. rer. nat.
- 电话号码：+49 89 289 24494
- 邮箱：Stephan.Mueller@mri.tum.de
研究联系人备份
- 姓名：Katharina Timper, Prof. Dr. med.
- 电话号码：+49 89 289 24930
- 邮箱：Katharina.Timper@mri.tum.de
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Participants of the RESIST trial at the TUM Klinikum, Munich:
adults aged 18-60 years with obesity (BMI ≥ 30 kg/m²) without manifest type 2 diabetes or structural cardiovascular disease, eligible for pharmacological weight-loss therapy and suitable for a structured resistance training program. Sufficient command of German is required.
描述
Inclusion Criteria:
- Provisional eligibility for randomization into the RESIST trial (based on all RESIST screening assessments available at the time of informed consent for this ancillary study)
- Written informed consent for this ancillary study
Exclusion Criteria:
- Non-randomization into the RESIST trial for any reason
Key eligibility criteria of the RESIST trial (for context only; full criteria see RESIST protocol RESIST-26-HAL-0150-I):
- Age 18-60 years
- Obesity (BMI ≥ 30 kg/m²)
- No manifest type 2 diabetes
- No structural cardiovascular disease
- Not pregnant or breastfeeding
- Sufficient command of the German language
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Resistance training + tirzepatide
RESIST participants randomized to the structured resistance training arm of the RESIST trial, receiving tirzepatide and individualized diet and physical activity counselling. Assignment occurs within RESIST, not within this ancillary study. |
Machine-based structured resistance training over 24 weeks (approx. 3 sessions per week), delivered within the RESIST trial (not part of this ancillary study). Progressive program with an acclimation phase (weeks 1-4) and a target phase (weeks 5-24; 8-12 repetitions at approx. 70-75% 1-RM, with additional eccentric overload from week 9). Sessions are intended to be fully supervised during the first 6 weeks whenever feasible, thereafter at least one supervised session after each interim visit; remaining sessions at the trial site or at partner fitness facilities. Once-weekly subcutaneous injection over 24 weeks, starting at 2.5 mg/week and increased by 2.5 mg every 4 weeks as tolerated up to a maximum of 10 mg/week, in accordance with the SmPC. Administered within the RESIST trial (not part of this ancillary study). |
|
Usual care + tirzepatide
RESIST participants randomized to the usual care arm of the RESIST trial, receiving tirzepatide and individualized diet and physical activity counselling. Assignment occurs within RESIST, not within this ancillary study. |
Once-weekly subcutaneous injection over 24 weeks, starting at 2.5 mg/week and increased by 2.5 mg every 4 weeks as tolerated up to a maximum of 10 mg/week, in accordance with the SmPC. Administered within the RESIST trial (not part of this ancillary study). |
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 concentration performance and processing speed
大体时间：Baseline (Week 0) and end of treatment (Week 24)
|
Concentration performance and processing speed computed per the d2-R manual from the electronic administration. |
Baseline (Week 0) and end of treatment (Week 24)
|
|
Change in food-related cognition
大体时间：Baseline (Week 0) and end of treatment (Week 24)
|
Total score, calculated as the sum of all items. |
Baseline (Week 0) and end of treatment (Week 24)
|
|
Change in trait food craving
大体时间：Baseline (Week 0) and end of treatment (Week 24)
|
Total score, calculated as the sum of all items; higher scores indicate stronger trait food craving (worse outcome). |
Baseline (Week 0) and end of treatment (Week 24)
|
|
Change in general functioning
大体时间：Baseline (Week 0) and end of treatment (Week 24)
|
Total score, calculated as the sum of all items; higher scores indicate greater disability (worse outcome). |
Baseline (Week 0) and end of treatment (Week 24)
|
|
Change in fatigue
大体时间：Baseline (Week 0) and end of treatment (Week 24)
|
Five subscale scores (general fatigue, physical fatigue, reduced motivation, reduced activity, mental fatigue), each the sum of its four items; higher scores indicate more fatigue (worse outcome). |
Baseline (Week 0) and end of treatment (Week 24)
|
|
Change in subjective sleep quality
大体时间：Baseline (Week 0) and end of treatment (Week 24)
|
Global score (2-week recall), sum of the seven component scores, range 0-21, analysed as a continuous variable; higher scores indicate worse sleep quality. Analysed as a continuous variable. |
Baseline (Week 0) and end of treatment (Week 24)
|
|
Change in work ability and work productivity - working participants only
大体时间：Baseline (Week 0) and end of treatment (Week 24)
|
WAI items 1, 2, 6 and 7 (raw responses, analysed individually); WPAI scores: % absenteeism, % presenteeism, % work productivity impairment, % activity impairment. Working participants only. |
Baseline (Week 0) and end of treatment (Week 24)
|
|
Change in self-concordance index of exercise motivation
大体时间：Baseline (Week 0) and end of treatment (Week 24)
|
Self-concordance index of the Self-Concordance of Sport- and Exercise-related Goals scale (SSK), scored according to the original instructions. Higher scores indicate more self-concordant motivation. |
Baseline (Week 0) and end of treatment (Week 24)
|
合作者和调查者
调查人员
- 首席研究员：Katharina Timper, Prof. Dr. med.、Klinikum der Technischen Universität München (TUM Klinikum)
- 首席研究员：StephanStephan Müller-Stegner, Dr. rer. nat.、Klinikum der Technischen Universität München (TUM Klinikum)
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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
- 2026-342-S-CT
- RESIST-26-HAL-0150-I (其他标识符：TUM Klinikum - protocol code of parent trial RESIST)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Individual participant data will not be shared outside the sponsor institution. Aggregated or fully anonymized data may be made available to researchers upon reasonable request to the Principal Investigators.
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