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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Stephan Müller-Stegner, Dr. rer. nat.
- 電話番号：+49 89 289 24494
- メール：Stephan.Mueller@mri.tum.de
研究連絡先のバックアップ
- 名前：Katharina Timper, Prof. Dr. med.
- 電話番号：+49 89 289 24930
- メール：Katharina.Timper@mri.tum.de
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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). |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in concentration performance and processing speed
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
捜査官
- 主任研究者：Katharina Timper, Prof. Dr. med.、Klinikum der Technischen Universität München (TUM Klinikum)
- 主任研究者：StephanStephan Müller-Stegner, Dr. rer. nat.、Klinikum der Technischen Universität München (TUM Klinikum)
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2026-342-S-CT
- RESIST-26-HAL-0150-I (その他の識別子：TUM Klinikum - protocol code of parent trial RESIST)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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