Physical EXercise as an Adjunct Treatment for Depression (PEXAT)

U

Université de Reims Champagne-Ardenne

Status

Completed

Conditions

Major Depressive Disorder

Treatments

Behavioral: physical exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT02612142
EPSMM-2011

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

48 participants in 3 patient groups

aerobic exercise (AE)
Experimental group
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).
Treatment:
Behavioral: physical exercise
stretching exercise (ST)
Sham Comparator group
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).
Treatment:
Behavioral: physical exercise
no intervention (NI)
No Intervention group
Description:
No behavioral intervention. All participants were treated with either paroxetine (20-50mg/day), fluoxetine (20-80mg/day) or bupropion (100-200mg/day).

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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