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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Stephan Müller-Stegner, Dr. rer. nat.
- 전화번호: +49 89 289 24494
- 이메일: Stephan.Mueller@mri.tum.de
연구 연락처 백업
- 이름: Katharina Timper, Prof. Dr. med.
- 전화번호: +49 89 289 24930
- 이메일: Katharina.Timper@mri.tum.de
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
|
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). |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in concentration performance and processing speed
기간: 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)
|
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Change in food-related cognition
기간: 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
기간: 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
기간: 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)
|
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Change in fatigue
기간: 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)
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Change in subjective sleep quality
기간: 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)
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Change in work ability and work productivity - working participants only
기간: 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)
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Change in self-concordance index of exercise motivation
기간: 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)
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Katharina Timper, Prof. Dr. med., Klinikum der Technischen Universität München (TUM Klinikum)
- 수석 연구원: StephanStephan Müller-Stegner, Dr. rer. nat., Klinikum der Technischen Universität München (TUM Klinikum)
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 2026-342-S-CT
- RESIST-26-HAL-0150-I (기타 식별자: TUM Klinikum - protocol code of parent trial RESIST)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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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