Aerobic Exercise as add-on Treatment for Inpatients With Depression

Aerobic Exercise as add-on Treatment for Inpatients With Depression: Effects and Biomarkers

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Aerobic exercise; Behavioral: Placebo control

Detailed Description

Patients are randomly assigned to the intervention group (IG) or control group (CG). The IG will train 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. CG will absolve a basic stretching and mobilisation program 3 times per week, also under supervision for 6 consecutive weeks. 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.

All patients will participate in the multimodal treatment program of the depression ward, which includes pharmacotherapy, psychotherapy and specialized therapies such as art therapy and ergotherapy.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4012
    • Psychiatric University Hospital
  • Solothurn, Switzerland, 4503
    • Psychiatric Services Solothurn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Any physical condition that prohibits endurance exercise
• 3 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Exercise (IG); 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
PLACEBO_COMPARATOR: Control (CG); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortisol awakening response (CAR)	Change of Salivary cortisol increase (Area under the curve, measured at awakening, +10, +20 and +30 minutes) from baseline until 6 months follow-up	Baseline (pre), 2 weeks, 6 weeks (post), 6 months (follow-up)
Brain derived neurotrophic factor (Serum-BDNF)	Change of Serum-BDNF	Baseline (pre), 2 weeks, 6 weeks (post), 6 months (followup)
Sleep (Subjective sleep Quality)	Change of Score of Pittsburgh sleep quality index (PSQI) from baseline until follow-up	Baseline (pre), 6 weeks (post), 6 months (followup)
Sleep (Polysomnography)	Change in sleep stages between baseline and follow-up	Baseline (pre), 6 weeks (post)
Cognition	Change in performance in Executive functions (alertness, working memory, flexibility, go/nogo, divided attention) measured by "Testbatterie zur Aufmerksamkeitsprüfung" (TAP)	Baseline (pre), 6 weeks (post), 6 months (followup)
Social stress - cortisol	Change of Salivary cortisol-course (Area under the curve) during Trier Social Stress Test (TSST)	Baseline (pre), 6 weeks (post)
Social stress - heartrate	Change of heartrate-course during Trier Social Stress Test (TSST)	Baseline (pre), 6 weeks (post)
Psychological symptoms	Change of scores in Symptom Checklist (SCL-90R) from baseline until follow-up	Baseline (pre), 6 weeks (post), 6 months (follow-up)
Mental Toughness	Change in score in Mental Toughness Questionnaire (MTQ18)from baseline until follow-up	Baseline (pre), 6 weeks (post), 6 months (followup)
Physical activity	Change of weekly physical activity as self reported by the International Physical Activity Questionnaire - Short Version (IPAQ-short)	Baseline (pre), 6 months (follow-up)
Sleep related personality traits	Change in Focussing and Rumination subscores of the "Fragebogen zur Erfassung von Persönlichkeitsmerkmalen Schlafgestörter" (FEPS II)	Baseline (pre), 6 weeks (post), 6 months (followup)
Body Mass Index (BMI)	Change(BMI)	Baseline (pre), 6 weeks (post), 6 months (followup)
Resting Heartrate (HR)	Change of HR	Baseline (pre), 6 weeks (post), 6 months (followup)
Blood Pressure (BP)	Change of BP	Baseline (pre), 6 weeks (post), 6 months (followup)
TNF-Alpha (additional value assessed/Amendment 1)	Change of TNF-alpha	Baseline (pre), 2 weeks (post), 6 weeks (post)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: University of Basel; Psychiatric Hospital of the University of Basel; Solothurner Spitäler AG
• Investigators: Principal Investigator: Christian Imboden, MD, Dr., Solothurner Spitäler AG

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ACTUAL): March 1, 2017

Study Registration Dates

• First Submitted: January 26, 2016
• First Submitted That Met QC Criteria: February 5, 2016
• First Posted (ESTIMATE): February 10, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 11, 2017
• Last Update Submitted That Met QC Criteria: April 10, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: EKBB 62/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO