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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Stephan Müller-Stegner, Dr. rer. nat.
- Número de teléfono: +49 89 289 24494
- Correo electrónico: Stephan.Mueller@mri.tum.de
Copia de seguridad de contactos de estudio
- Nombre: Katharina Timper, Prof. Dr. med.
- Número de teléfono: +49 89 289 24930
- Correo electrónico: Katharina.Timper@mri.tum.de
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in concentration performance and processing speed
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Katharina Timper, Prof. Dr. med., Klinikum der Technischen Universität München (TUM Klinikum)
- Investigador principal: StephanStephan Müller-Stegner, Dr. rer. nat., Klinikum der Technischen Universität München (TUM Klinikum)
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Trastornos Nutricionales
- Sobrenutrición
- Peso corporal
- Trastornos del sueño y la vigilia
- Exceso de peso
- Trastornos del Sueño Intrínsecos
- Disomnias
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Obesidad
- Fatiga
- Trastornos de iniciación y mantenimiento del sueño
- Aminoácidos, péptidos y proteínas
- Proteínas
- Receptor de péptido-1 tipo glucagón
- Receptores de péptidos tipo glucagón
- Receptores, acoplados a la proteína G
- Receptores, superficie celular
- Proteínas de membrana
- Receptores, hormona gastrointestinal
- Receptores, péptido
- Tirzepatide
Otros números de identificación del estudio
- 2026-342-S-CT
- RESIST-26-HAL-0150-I (Otro identificador: TUM Klinikum - protocol code of parent trial RESIST)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .