NCT02541136

Brief Summary

Stress-related disorders have a profound impact on public health. The World Health Organisation (WHO) found major depressive disorder (MDD) to be one of the most important human health problems with a prevalence of about 10%. In the current proposal the aim is to investigate mechanisms of resilience against stress-related disorders and to examine changes in quality of life, health, brain structure and brain function in individuals performing a "resilience" programme. Therefore, the investigators will recruit forty healthy subjects from the hospital staff exposed to "normal" day-to-day stress and not participating already in a fitness programme. Half of the subjects will be randomised to a cognitive behavioural self-experience and exercise programme for 20 weeks carried out by experienced supervisors, coaches and trainers. Clinical psychological and psychiatric examinations will be carried out weekly and a range of sophisticated neuroimaging techniques - high angular resolution diffusion imaging (HARDI) and functional MRI (fMRI) - will be conducted before and after the "resilience" program in order to investigate its effectiveness on brain structure and function. The stress system will also be tested by examining cortisol awaking response (CAR) and daily rhythms of cortisol secretion. These techniques are all well established in our laboratories. The proposed research will likely stimulate the development of new prevention strategies for this common and important disorder, and in the future could be applied to other illnesses. Moreover, when successful it could be patented and offered for implementation in the daily routine of median to large companies.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
Last Updated

September 4, 2015

Status Verified

September 1, 2015

Enrollment Period

3 years

First QC Date

August 28, 2015

Last Update Submit

September 3, 2015

Conditions

Keywords

exerciseresiliencephysiotherapyfMRI

Outcome Measures

Primary Outcomes (1)

  • Resting state functional MRI

    Magnetic resonance images from each participant were obtained with a Philips Achieva MRI scanner (Philips Medical System, Veenphuis 4-6, 5684 PC Best, The Netherlands) operating at 3 Tesla. The functional images were collected in single runs using a gradient echo (TE=28ms; TR=2000; field of view=131mm, flip angle=90°) sensitive to blood oxygenation level-dependent (BOLD) contrast (T2\* weighting). A total of 37 contiguous 3.2 mm-thick slices were acquired parallel to the anterior posterior commissure plane (3mm approximately isotropic resolution), providing complete brain coverage. The fMRI run included 220 volumes acquired continuously lasting 7.2 min in total. Structural data (for definitive atlas transformation) included a high resolution sagittal, 3D T1-weighted Turbo Gradient Echo Sequence (TE=3.9ms, TR=8.5ms, TI=1060ms, flip angle=8°), 256×240 acquisition matrix, 1×1×1 mm voxels) scan. Resting state data were analysed using the software programs SPM8 and CONN

    16 weeks

Secondary Outcomes (3)

  • Questionnaire for mental well being

    16 weeks

  • Questionnaire on physical activity

    16 weeks

  • Questionnaire on physical health

    16 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

Participants in this arm took part in the aerobic exercise component of the study and attended St. James's Hospital in Dublin twice a week for 16 weeks. Furthermore, exercising participants were asked to engage in recorded aerobic activity outside of the class, which followed a standardised progression from 1-3 additional sessions, at the same intensity as the week's class.

Behavioral: Aerobic Exercise

Control

NO INTERVENTION

Participants in the control group didn't change their sedentary habits.

Interventions

Each exercise class consisted of a warm-up, an aerobic and a cool-down phase, supervised by a physiotherapist. The warm up and cool down phases consisted of 5-7 minutes of low intensity aerobic exercise, \< 40% Heart Rate Reserve (HHR), to allow the cardiopulmonary and musculoskeletal systems to adapt and recover, respectively. The aerobic component initially consisted of 21 minutes at an intensity of 40-59% HRR and was progressed to 42 minutes at 55-75% HRR by week 8 until programme completion. All participants worked at the same intensity and duration at the various time points throughout the study. Continuous, rhythmic exercise using large muscle groups was prescribed using treadmills, cycle ergometers and other aerobic exercise that increased heart rate to its prescribed level.

Exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy participants

You may not qualify if:

  • internal or neurological disorders
  • substance or alcohol abuse
  • substance or alcohol dependency in the past
  • cortisol therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Prince M, Patel V, Saxena S, Maj M, Maselko J, Phillips MR, Rahman A. No health without mental health. Lancet. 2007 Sep 8;370(9590):859-77. doi: 10.1016/S0140-6736(07)61238-0.

    PMID: 17804063BACKGROUND
  • Duman RS. Pathophysiology of depression: the concept of synaptic plasticity. Eur Psychiatry. 2002 Jul;17 Suppl 3:306-10. doi: 10.1016/s0924-9338(02)00654-5.

    PMID: 15177086BACKGROUND
  • Frodl TS, Koutsouleris N, Bottlender R, Born C, Jager M, Scupin I, Reiser M, Moller HJ, Meisenzahl EM. Depression-related variation in brain morphology over 3 years: effects of stress? Arch Gen Psychiatry. 2008 Oct;65(10):1156-65. doi: 10.1001/archpsyc.65.10.1156.

    PMID: 18838632BACKGROUND
  • Frodl T, Reinhold E, Koutsouleris N, Donohoe G, Bondy B, Reiser M, Moller HJ, Meisenzahl EM. Childhood stress, serotonin transporter gene and brain structures in major depression. Neuropsychopharmacology. 2010 May;35(6):1383-90. doi: 10.1038/npp.2010.8. Epub 2010 Feb 10.

    PMID: 20147891BACKGROUND
  • Dichter GS, Felder JN, Smoski MJ. The effects of Brief Behavioral Activation Therapy for Depression on cognitive control in affective contexts: An fMRI investigation. J Affect Disord. 2010 Oct;126(1-2):236-44. doi: 10.1016/j.jad.2010.03.022. Epub 2010 Apr 24.

    PMID: 20421135BACKGROUND
  • Frodl T, Bokde AL, Scheuerecker J, Lisiecka D, Schoepf V, Hampel H, Moller HJ, Bruckmann H, Wiesmann M, Meisenzahl E. Functional connectivity bias of the orbitofrontal cortex in drug-free patients with major depression. Biol Psychiatry. 2010 Jan 15;67(2):161-7. doi: 10.1016/j.biopsych.2009.08.022.

    PMID: 19811772BACKGROUND
  • Frodl T, Strehl K, Carballedo A, Tozzi L, Doyle M, Amico F, Gormley J, Lavelle G, O'Keane V. Aerobic exercise increases hippocampal subfield volumes in younger adults and prevents volume decline in the elderly. Brain Imaging Behav. 2020 Oct;14(5):1577-1587. doi: 10.1007/s11682-019-00088-6.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Thomas Frodl, MD

    University of Dublin, Trinity College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 28, 2015

First Posted

September 4, 2015

Study Start

October 1, 2011

Primary Completion

October 1, 2014

Study Completion

April 1, 2015

Last Updated

September 4, 2015

Record last verified: 2015-09