NCT00695552

Brief Summary

This trial investigates the biological effect of exercise training on depression. Participants will randomly be allocated to either a aerobic exercise group performing exercise on stationary bikes or a group performing low-impact exercise such as stretching exercises. Both groups will attend sessions three times per week for 3 months. Before and after the intervention the investigators will measure the severity of depression using the Hamilton depression rating scale (HAM-D17).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

2.3 years

First QC Date

June 10, 2008

Last Update Submit

May 9, 2023

Conditions

Major Depression

Keywords

Major depression, exercise

Outcome Measures

Primary Outcomes (1)

  • HAM-D17

    Before and after 3 months intervention

Secondary Outcomes (1)

  • Remission from depression (not fulfilling the DSM-IV criteria for depression and a hamilton rating below 8)

    Before and after 3 months intervention

Study Arms (2)

1

EXPERIMENTAL

Aerobic exercise on stationary bikes. Three sessions/week for 3 three months. First month the workload is equivalent to 65% of HRmax, the second month the workload is equivalent to 70% of HRmax, and the third month the workload is equivalent to 75% of HRmax

Behavioral: Aerobic exercise

2

PLACEBO COMPARATOR

Participants meets 3 times/week for 3 months. They will engage in low impact activities such as stretching exercises.

Behavioral: Low impact exercise

Interventions

Aerobic exerciseBEHAVIORAL

Aerobic exercise on stationary bikes. Three sessions/week for 3 three months. First month the workload is equivalent to 65% of HRmax, the second month the workload is equivalent to 70% of HRmax, and the third month the workload is equivalent to 75% of HRmax

1
Low impact exerciseBEHAVIORAL

Participants meets 3 times/week for 3 months. They will engage in low impact activities such as stretching exercises

2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • Major depression according to DSM-IV
  • Living within 30 km of training facilities
  • Able to read and understand informed consent

You may not qualify if:

  • Recreational or current drug abuse
  • Having used antidepressant medication within the last 2 months
  • Contraindications to physical exercise
  • Recreational exercise\> 1 hour per week
  • Medication for diabetes, hypertension, or any kidney disease
  • Suicidal behaviour (ham-d17 item3 \> 2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Center Bispebjerg

Copenhagen, 2400, Denmark

Location

Related Publications (2)

  • Krogh J, Rostrup E, Thomsen C, Elfving B, Videbech P, Nordentoft M. The effect of exercise on hippocampal volume and neurotrophines in patients with major depression--a randomized clinical trial. J Affect Disord. 2014 Aug;165:24-30. doi: 10.1016/j.jad.2014.04.041. Epub 2014 Apr 23.

    PMID: 24882173DERIVED

  • Krogh J, Videbech P, Thomsen C, Gluud C, Nordentoft M. DEMO-II trial. Aerobic exercise versus stretching exercise in patients with major depression-a randomised clinical trial. PLoS One. 2012;7(10):e48316. doi: 10.1371/journal.pone.0048316. Epub 2012 Oct 31.

    PMID: 23118981DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jesper Krogh, M.D

    Psychiatric Center Bispebjerg, Bispebjerg University Hospital, Copenhagen Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 10, 2008

First Posted

June 12, 2008

Study Start

September 1, 2008

Primary Completion

January 1, 2011

Study Completion

April 1, 2011

Last Updated

May 11, 2023

Record last verified: 2023-05

Locations

DK(1)