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Lifestyle physical activity counselling for in-patients with major depressive disorder

Lifestyle Physical Activity Counselling for IN-PATients with major depressive disorder: Randomized controlled trial on physical activity, cardiorespiratory fitness, depression, and cardiovascular health risk markers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10469580
Enrollment
334
Registered
2018-09-03
Start date
2018-10-15
Completion date
Unknown
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression Mental and Behavioural Disorders Major depressive disorder (MDD)

Interventions

Patients will be randomly assigned (stratified by age, gender, and depression severity) to an extended personalised physical activity and exercise counselling program (intervention group) or to genera

Sponsors

Swiss National Science Foundation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years 2. Major depressive disorders according to ICD-10 diagnostic criteria (F31 type II, F32 or F33) 3. 17-item Hamilton Rating Scale for Depression (HAMD17) score =17 (moderate depression) 4. Beck's Depression Inventory II (BDI-II) score =17 (borderline clinical depression) 5. Currently not meeting the American College of Sports Medicine's physical activity recommendations (International Physical Activity Questionnaire (IPAQ) <150 minutes/week of moderate-to-vigorous physical activity) 6. Read and signed written informed consent 7. Ability to read and speak German

Exclusion criteria

Exclusion criteria: 1. History of bipolar disorder type I (F31 type I) 2. History of schizophrenia or schizoaffective disorder 3. Current active alcohol or drug abuse or dependence 4. Pathological electrocardiogram (ECG) 5. Any significant medical condition that contraindicates safe participation in physical activity 6. Pregnancy or breastfeeding 7. Active suicidal intent 8. Evidence of significant cardiovascular, neuromuscular or endocrine disorders limiting regular physical activity as per American College of Sports Medicine absolute contraindications to exercise

Design outcomes

Primary

MeasureTime frame
1. Objective physical activity, assessed using an Actigraph accelerometer for a seven day period with a sampling epoch of 10 seconds. Time spent in moderate physical activity and vigorous physical activity will be determined based on the accelerometer counts and the ActiLife® computer software. Only days with at least 13 hours of wear time will be considered as a valid measure of daily activity. Participants will need at least five valid days, = 4 weekdays and = 1 a weekend day, for the data to be included in the data analyses. This will be assessed at the baseline (1-2 weeks after hospitalisation), 6 weeks after hospitalisation and at the follow-up (12 months after hospitalisation) 2. Physical activities during which the accelerometer cannot be worn (i.e. swimming), assessed using a non-wear time sheet

Secondary

MeasureTime frame
The following will be assessed at the baseline (1-2 weeks after hospitalisation), 6 weeks after hospitalisation and at the follow-up (12 months after hospitalisation): 1. Self-reported physical activity, assessed using the Simple Physical Activity Questionnaire (SIMPAQ) 2. Cardiorespiratory fitness, assessed using the Åstrand indirect test of maximal oxygen uptake (VO2max) 3. Autonomic function, assessed using electrocardiography (ECG) 4. Cognitive and social determinants of exercise, assessed using various validated questionnaires: 4.1. 1-item proxy for perceived fitness 4.2. 3 items regarding exercise-related self-efficacy 4.3. 16 items regarding exercise-related outcome expectancies 4.4. 1 item regarding exercise intention 4.5. 12 item SSK-Scale for self-concordance 4.6. 10 items regarding action and coping planning 4.7. 19 items regarding perceived exercise barriers 4.8. 7 items regarding exercise-related social support 5. Depression severity, assessed using: 5.1. Hamilton Rating Scale for Depression 17-item (HAMD17) 5.2. Beck Depression Inventory (BDI) 6. Self-perceived physical and psychological health, assessed using the Medical Outcomes Study 12-item Short Form Health Survey (SF-12) 7. Insomnia symptoms, assessed using the 7-item Insomnia Severity Index (ISI) 8. Cognitive function, assessed using the Test of Attentional Performance 9. Cardiovascular health risk markers: 9.1. Blood pressure, assessed using an Omron® digital blood pressure monitor 9.2. Body mass index (BMI) assessed by body weight (measured using a digital weighing scale BC-545, Tanita, USA) and body height (measured using a stadiometer) using the formula BMI = weight (kg) / (standing height (meters) squared) 9.3. Percentage body fat, assessed using bioelectrical impedance analysis using a digital weighing scale (BC-545) 9.4. Waist circumference, assessed using flexible tape at the natural waist 9.5. Total/LDL/HDL cholesterol, triglycerides and HbA1c, assessed using antecubital vein blood test

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026