Physical EXercise as an Adjunct Treatment for Depression

Major Depressive Disorder Clinical Trial

— PEXAT  

Official title:

Efficacy of Exercise as an Adjunct Treatment for Clinically Depressed Inpatients During the Initial Stages of Antidepressant Therapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612142
• Other study ID #: EPSMM-2011
• Status: Completed
• Phase: N/A
• First received: November 19, 2015
• Last updated: November 21, 2015
• Start date: June 2011
• Est. completion date: July 2015

Study information

• Verified date: November 2015
• Source: Université de Reims Champagne-Ardenne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministère de l'Enseignement supérieur et de la Recherche
• Study type: Interventional

Clinical Trial Summary

35 participants diagnosed with major depressive disorder were randomized in 3 intervention groups: (1) aerobic exercise (AE) ; (2) placebo (stretching) exercise (ST); and (3) no intervention (control group; NI). The intervention length was 10 consecutive days. In groups 1 (aerobic exercise) and 2 (sham exercise), participants exercised for 30 minutes each day. Depressive symptoms were assessed the day before the beginning of intervention and the day after the end of intervention for participants of both groups.

Description:

In the aerobic exercise (AE) group, the intervention consisted of 30 minutes of daily brisk walking or jogging. This was done individually and supervised. Participants who missed > 2 training sessions were considered as non-completers. Exercise intensity had to be maintained within 65%-75% of age-predicted maximal heart rate, as commonly prescribed in studies using aerobic exercise to alleviate depression. Heart rate monitoring devices were used.

Participants in the stretching (ST) group also performed a daily 30 minutes exercise program but this was "sham" exercise, consisting of stretching exercises. Several muscle groups (thighs, calves, gluteal, shoulders, back) were stretched for 60 seconds, with equivalent resting intervals between stretching series. These activities were also individual and supervised. As was the case for the AE intervention, participants who missed > 2 training sessions were considered as non-completers.

Participants in the control (NI) group received no intervention other than prescribed medication.

All participants started antidepressants within less than 2 weeks before study entry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of major depressive disorder (MDD)

• antidepressant drug therapy initiated for less than 2 weeks

• score of 29 or more on the Beck depression inventory

Exclusion Criteria:

• medical contraindication for exercise practice

• inability to understand written French

• beta-blocking drugs or another forms of antidepressant therapy (sleep deprivation, electroconvulsive therapy)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• physical exercise
endurance-training or stretching (sham exercise)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Université de Reims Champagne-Ardenne

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score change on the 21-item Beck depression inventory (BDI-II). Each item has a set of severity-graded self-evaluative statements that are rated 0 (neutral) to 3 (maximum severity).		Baseline and 10 days	No