Aerobic Exercise as add-on Treatment for Inpatients With Depression

NCT02679053 | Completed

• 1 other identifier: EKBB 62/13
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study is to evaluate the effect of 6 weeks of aerobic endurance exercise as adon treatment for moderately to severely depressed inpatients. Endpoints are symptom severity, psychological variables, cognitive symptoms, sleep, hypothalamic-pituitary-adrenal axis (HPA-axis), Brain-derived neurotrophic factor (BDNF) and heartrate variability (HRV). Amendment 1 (Nov. 2016): additional evaluation of TNF-alpha at baseline, +2 weeks and post (+6weeks) in already existing blood samples.

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

• Depressive Symptoms self rated

  Change in Score of Hamilton Depression Rating Scale (HDRS-17) from baseline until 6 months follow-up

  Baseline (pre), 1 week, 2 weeks, 6 weeks (post), 6 months (followup)

• Depressive Symptoms physician rated

  Change in Score of Beck Depression Inventory (BDI) from baseline until 6 months follow-up

  Baseline (pre), 1 week, 2 weeks, 6 weeks (post), 6 months (follow-up)

Secondary Outcomes (15)

• Cortisol awakening response (CAR)

  Baseline (pre), 2 weeks, 6 weeks (post), 6 months (follow-up)

• Brain derived neurotrophic factor (Serum-BDNF)

  Baseline (pre), 2 weeks, 6 weeks (post), 6 months (followup)

• Sleep (Subjective sleep Quality)

  Baseline (pre), 6 weeks (post), 6 months (followup)

• Sleep (Polysomnography)

  Baseline (pre), 6 weeks (post)

• Cognition

  Baseline (pre), 6 weeks (post), 6 months (followup)

Study Arms (2)

Exercise (IG)

EXPERIMENTAL

Aerobic exercise three times per week on indoor bicycles at 60 to 75% of maximal heartrate aiming at a weekly total of 17.5kcal/kg bodyweight for 6 consecutive weeks. The exercise will take place under supervision. At the end of every week physical fitness is evaluated by the queens step test.No other activities with moderate or high intensity are allowed throughout the intervention time.

Behavioral: Aerobic exercise

Control (CG)

PLACEBO COMPARATOR

Basic stretching and mobilisation program 3 times per week each for approx. 40 minutes, also under supervision for 6 consecutive weeks. At the end of every week physical fitness is evaluated by the queens step test.At the end of every week physical fitness is evaluated by the queens step test.No other activities with moderate or high intensity are allowed throughout the intervention time.

Behavioral: Placebo control

Interventions

Aerobic exercise BEHAVIORAL

Exercise (IG)

Placebo control BEHAVIORAL

Control (CG)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Inpatient treatment on the Depression ward
• International Classification of Diseases (ICD)-10: F32, F33 or F31
• HDRS-17\>16 Points
• written informed consent

You may not qualify if:

• Any physical condition that prohibits endurance exercise
• or more cardiovascular risk factors (hypertonia, family history, smoking, hypertriglyceridemia, diabetes)
• pathological ECG
• BMI \> 35 kg/m2
• Pregnancy
• acute suicidal Ideation
• comorbid substance dependence (except nicotine)
• Major comorbid psychiatric disorder
• regular high intensity exercise prior to treatment

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Psychiatric Hospital of the University of Basel: collaborator
• University of Basel: collaborator
• Solothurner Spitäler AG: collaborator

Study Sites (2)

Psychiatric University Hospital

Basel, Basel, 4012, Switzerland

Location

Psychiatric Services Solothurn

Solothurn, Canton of Solothurn, 4503, Switzerland

Location

Related Publications (1)

• Imboden C, Gerber M, Beck J, Eckert A, Puhse U, Holsboer-Trachsler E, Hatzinger M. Effects of Aerobic Exercise as Add-On Treatment for Inpatients With Moderate to Severe Depression on Depression Severity, Sleep, Cognition, Psychological Well-Being, and Biomarkers: Study Protocol, Description of Study Population, and Manipulation Check. Front Psychiatry. 2019 Apr 25;10:262. doi: 10.3389/fpsyt.2019.00262. eCollection 2019.

  PMID: 31073292 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Christian Imboden, MD, Dr.

  Solothurner Spitäler AG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: February 10, 2016
• Study Start: October 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 11, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)