CAPE (caffeine and physical performance in mental illness)

Recruiting

• Conditions: F32.1; Moderate depressive episode

• Registration Number: DRKS00033793
• Lead Sponsor: Klinik für Psychiatrie, Psychotherapie und Psychosomatik der Universität Augsburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Sufficient knowledge of German
Ability to consent
Voluntary treatment
Diagnosis of a depressive episode
No diagnosed, current addiction disorder (nicotine, alcohol, illegal drugs)
No contraindication to exercise
Stable long-term medication (one week)
BMI < 30 kg/m²
No known high consumption of other caffeinated drinks or foods (> 1 cup of black or green tea/day, daily consumption of energy drinks or dietary supplements containing caffeine

Exclusion Criteria

Age < 18 years or > 65 years
Lack of knowledge of German
Lack of ability to consent
Involuntary treatment
Diagnosed current addiction disorder (nicotine, alcohol, illegal drugs)
Contraindications to physical exercise
Pregnancy and breast feeding period
Taking steroids during the study period
Known high consumption of other caffeinated drinks or
Food (> 1 cup of black or green tea/day, daily consumption of energy drinks or dietary supplements with caffeine)
Relevant orthopedic or internal diseases that prevent cardiopulmonary exercise

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is VO2max (maximum oxygen uptake) and is measured using spiroergometry. Spiroergometry is a diagnostic procedure in which the reaction of the heart, circulation, breathing and metabolism as well as performance is examined by measuring respiratory gases during physical exertion. This parameter is collected at the baseline visit at the beginning and at the follow-up visit after the 12-week intervention.

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints are mentioned below and the respective measurement method is mentioned in brackets:<br>Strength (hand dynamometry, standing broad jump)<br>Muscular endurance (bent arm hang, sit-ups)<br>Speed (Plate Tapping)<br>Flexibility (Sit and Reach Test)<br>Balance (Flamingo Balance Test)<br>(objective) physical activity & mobility (IPAQ, pedometer Actigraph)<br>Vital signs (blood pressure monitor, body scale)<br>Body fat measurement (Caliper)<br>Functional Level & Quality of Life (GAF)<br>Mood (BDI, HAMD, PANAS, PHQ-9)<br>Cognition (TMT A/B)<br>Nutrition/caffeine (protocol management)<br>Endocrinological (blood value Apelin (EDTA))<br>Cardiological (long-term ECG, echo)<br><br>All parameters are collected at the baseline visit at the beginning and at the follow-up visit after the 12-week intervention.