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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Stephan Müller-Stegner, Dr. rer. nat.
- Номер телефона: +49 89 289 24494
- Электронная почта: Stephan.Mueller@mri.tum.de
Учебное резервное копирование контактов
- Имя: Katharina Timper, Prof. Dr. med.
- Номер телефона: +49 89 289 24930
- Электронная почта: Katharina.Timper@mri.tum.de
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
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.
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
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). |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in concentration performance and processing speed
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Katharina Timper, Prof. Dr. med., Klinikum der Technischen Universität München (TUM Klinikum)
- Главный следователь: StephanStephan Müller-Stegner, Dr. rer. nat., Klinikum der Technischen Universität München (TUM Klinikum)
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания нервной системы
- Психические расстройства
- Расстройства питания
- Переедание
- Масса тела
- Расстройства сна и бодрствования
- Избыточный вес
- Расстройства сна, внутренние
- Диссомнии
- Патологические состояния, признаки и симптомы
- Пищевые и метаболические заболевания
- Признаки и симптомы
- Ожирение
- Усталость
- Нарушения засыпания и поддержания сна
- Аминокислоты, пептиды и белки
- Белки
- Глюкагоноподобный рецептор пептида-1
- Глюкагоноподобные пептидные рецепторы
- Рецепторы, G-белок связаны
- Рецепторы, клеточная поверхность
- Мембранные белки
- Рецепторы, желудочно -кишечный гормон
- Рецепторы, пептид
- Тирзепатид
Другие идентификационные номера исследования
- 2026-342-S-CT
- RESIST-26-HAL-0150-I (Другой идентификатор: TUM Klinikum - protocol code of parent trial RESIST)
Планирование данных отдельных участников (IPD)
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Описание плана IPD
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.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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