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Physical EXercise as an Adjunct Treatment for Depression (PEXAT)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
physical exercise
Sponsored by
Université de Reims Champagne-Ardenne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Sham Comparator

    No Intervention

    Arm Label

    aerobic exercise (AE)

    stretching exercise (ST)

    no intervention (NI)

    Arm Description

    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).

    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).

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

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    November 19, 2015
    Last Updated
    November 21, 2015
    Sponsor
    Université de Reims Champagne-Ardenne
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02612142
    Brief Title
    Physical EXercise as an Adjunct Treatment for Depression
    Acronym
    PEXAT
    Official Title
    Efficacy of Exercise as an Adjunct Treatment for Clinically Depressed Inpatients During the Initial Stages of Antidepressant Therapy.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2011 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Université de Reims Champagne-Ardenne

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    aerobic exercise (AE)
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    stretching exercise (ST)
    Arm Type
    Sham Comparator
    Arm Description
    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).
    Arm Title
    no intervention (NI)
    Arm Type
    No Intervention
    Arm Description
    No behavioral intervention. All participants were treated with either paroxetine (20-50mg/day), fluoxetine (20-80mg/day) or bupropion (100-200mg/day).
    Intervention Type
    Behavioral
    Intervention Name(s)
    physical exercise
    Intervention Description
    endurance-training or stretching (sham exercise)
    Primary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zodi Imad, MD
    Organizational Affiliation
    Etablissement Public de Santé Mentale de la Marne
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Physical EXercise as an Adjunct Treatment for Depression

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