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Physical EXercise as an Adjunct Treatment for Depression

NCT ID: NCT02612142

Last Updated: 2015-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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aerobic exercise (AE)

Intervention type: Behavioral. Intervention name: Aerobic exercise Intervention description: 10 days of daily aerobic exercise (brisk walking, jogging); duration: 30 minutes per session; intensity: 65%-75% of age-predicted maximal heart rate. All participants were treated with either paroxetine (20-50mg/day), fluoxetine (20-80mg/day) or bupropion (100-200mg/day).

Group Type EXPERIMENTAL

physical exercise

Intervention Type BEHAVIORAL

endurance-training or stretching (sham exercise)

stretching exercise (ST)

Intervention type: Behavioral. Intervention name: Stretching exercise Intervention description: 10 days of daily stretching exercise; duration: 30 minutes per session. All participants were treated with either paroxetine (20-50mg/day), fluoxetine (20-80mg/day) or bupropion (100-200mg/day).

Group Type SHAM_COMPARATOR

physical exercise

Intervention Type BEHAVIORAL

endurance-training or stretching (sham exercise)

no intervention (NI)

No behavioral intervention. All participants were treated with either paroxetine (20-50mg/day), fluoxetine (20-80mg/day) or bupropion (100-200mg/day).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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physical exercise

endurance-training or stretching (sham exercise)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Reims Champagne-Ardenne

OTHER

Sponsor Role lead

Responsible Party

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Fabien Legrand

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zodi Imad, MD

Role: PRINCIPAL_INVESTIGATOR

Etablissement Public de Santé Mentale de la Marne

Other Identifiers

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EPSMM-2011

Identifier Type: -

Identifier Source: org_study_id