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Completed

NCT Number: NCT02612142

Physical EXercise as an Adjunct Treatment for Depression

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Physical exercise

Behavioral

endurance-training or stretching (sham exercise)

Primary outcomes

  1. 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).

    Time frame: Baseline and 10 days

Sponsors and collaborators

Lead sponsor

Université de Reims Champagne-Ardenne

Other

Registry information

Official study title

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

Acronym: PEXAT

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 23, 2015
Registry last updated
Nov 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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