Rehabilitation for Improved Cognition (RECO)

March 2, 2017 updated by: Umeå University

Effects on Cognitive Function, Estimated as a Global Brain Score, by Cognitive and Physical Fitness Training Added to a Multimodal Rehabilitation Program for Patients With Exhaustion Disorder

Many patients with exhaustion disorders continue to have significant difficulties with attention and memory function which reduce their work ability. This randomized study investigates whether the addition of a 12-week period of specific cognitive training or physical fitness training could further enhance cognitive function in patients with exhaustion disorder participating in a multimodal rehabilitation program.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study was performed at The Stress Rehabilitation Clinic at the University hospital of Umeå. In total 161 patients with diagnosed exhaustion disorder were recruited consecutively to the study from March 2010 until June 2013. Participants were all in age span 18-60 years old, had an ongoing employment and were assessed as suitable for a 24-week multimodal rehabilitation, which consisted of cognitive behavioural therapy in group (maximum eight persons), prescription of physical activity/exercise (FaR©) and vocational measures with rehabilitation meetings. A randomization by group was performed after 12 weeks of multimodal rehabilitation to one of three conditions; A/ continued multimodal rehabilitation, B/ addition of a computer-based cognitive training, and C/ addition of physical fitness training. The added training was performed during the last 12 weeks of rehabilitation (week 12 to 24) and with three weekly training occasions. Primary endpoint was change in cognitive functioning, estimated as a global brain score. Secondary endpoints were changes in different specific neuropsychological tasks, estimated psychological wellbeing, physical capacity, work ability, health-related quality of life and cost-effectiveness. A long-term follow-up was performed one year after termination of the interventions (at week 76).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
161

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Umea, Sweden, 90333
        • Stress Rehabilitation Clinic, Umeå university hospital, Västerbotten county council

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed exhaustion disorder according to criteria established by the Swedish National Board of Health and Welfare
  • 18 - 60 years of age
  • Current employment
  • Considered suitable for multimodal rehabilitation in group

Exclusion Criteria:

  • Need of other treatment or rehabilitation
  • Abuse of alcohol or drugs
  • Participation in another intervention study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Continued multimodal rehabilitation
No addition of extra training in this group. Only ordinary continued multimodal rehabilitation.
Active Comparator: Computer-based cognitive training
This arm also consisted of continued multimodal rehabilitation.
Behavioral: Computer-based cognitive training
A total of 36 training sessions, approximately 20 minutes long each. Five different tasks were used in training all tapping different aspects of cognitive control such as updating, shifting, visuo-spatial working memory and episodic memory binding.
Active Comparator: Physical fitness training
This arm also consisted of continued multimodal rehabilitation.
Behavioral: Physical fitness training
A total of 36 training sessions, approximately 40 minutes long each, with physical fitness training performed as group indoor cycling. The participants were instructed to attain a load of approximately 65-80% of their maximum heart rate.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Short-term change in global brain score
Time Frame: Week 12 and 24
The global brain score was calculated from ten neuropsychological tasks covering different domains in cognitive functioning
Week 12 and 24
Long-term change in global brain score
Time Frame: Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects
The global brain score was calculated from ten neuropsychological tasks covering different domains in cognitive functioning
Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Short-term change in "letter memory running span task"
Time Frame: Week 12 and 24
A measure of the updating functioning
Week 12 and 24
Long-term change in "letter memory running span task"
Time Frame: Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects
A measure of the updating functioning
Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects
Short-term change in "3-back task"
Time Frame: Week 12 and 24
A measure of the updating functioning
Week 12 and 24
Long-term change in "3-back task"
Time Frame: Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects
A measure of the updating functioning
Week 12, 24 and 76, mixed model with several time points used to estimate long-term effects
Short-term change in the "colour word interference test (the Stroop test)"
Time Frame: Week 12 and 24
A measure of the inhibition functioning, from D-KEFS
Week 12 and 24
Long-term change in the "colour word interference test (the Stroop test)"
Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
A measure of the inhibition functioning, from D-KEFS
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Short-term change in the "trail making test"
Time Frame: Week 12 and 24
A measure of attentional shifting, from D-KEFS
Week 12 and 24
Long-term change in the "trail making test"
Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
A measure of attentional shifting, from D-KEFS
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Short-term change in the "digit span forward test"
Time Frame: Week 12 and 24
A measure of the working memory, from WAIS-R
Week 12 and 24
Long-term change in the "digit span forward test"
Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
A measure of the working memory, from WAIS-R
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Short-term change in the "digit span backward test"
Time Frame: Week 12 and 24
A measure of the working memory, from WAIS-R
Week 12 and 24
Long-term change in the "digit span backward test"
Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
A measure of the working memory, from WAIS-R
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Short-term change in the "letter-number sequencing" test
Time Frame: Week 12 and 24
A measure of the working memory, from WAIS-III
Week 12 and 24
Long-term change in the "letter-number sequencing" test
Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
A measure of the working memory, from WAIS-III
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Short-term change in the "recall of concrete nouns" test (Buschke's selective reminding procedure)
Time Frame: Week 12 and 24
A measure of the episodic memory
Week 12 and 24
Long-term change in the "recall of concrete nouns" test (Buschke's selective reminding procedure)
Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
A measure of the episodic memory
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Short-term change in the "digit symbol" test
Time Frame: Week 12 and 24
A measure of perceptual speed, from WAIS-R
Week 12 and 24
Long-term change in the "digit symbol" test
Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
A measure of perceptual speed, from WAIS-R
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Short-term change in "Raven's advanced progressive matrices"
Time Frame: Week 12 and 24
A measure of non-verbal reasoning ability
Week 12 and 24
Long-term change in "Raven's advanced progressive matrices"
Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
A measure of non-verbal reasoning ability
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Short-term change in Shirom Melamed Burnout Questionnaire
Time Frame: Week 12 and 24
A burnout measure
Week 12 and 24
Long-term change in Shirom Melamed Burnout Questionnaire
Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
A burnout measure
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Short-term change in Short Form 36 item Health Questionnaire
Time Frame: Week 12 and 24
Health-related quality of life estimate
Week 12 and 24
Long-term change in Short Form 36 item Health Questionnaire
Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Health-related quality of life estimate
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Short-term change in Checklist Individual Strength Questionnaire
Time Frame: Week 12 and 24
Measure of fatigue
Week 12 and 24
Long-term change in Checklist Individual Strength Questionnaire
Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Measure of fatigue
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Short-term change in Hospital Anxiety and Depression Scale, HAD-S
Time Frame: Week 12 and 24
A measure of anxiety and depression
Week 12 and 24
Long-term change in Hospital Anxiety and Depression Scale, HAD-S
Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
A measure of anxiety and depression
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Short-term change in aerobic capacity
Time Frame: Week 12 and 24
A submaximal cycle ergometer test performed to estimate maximal oxygen uptake
Week 12 and 24
Long-term change in aerobic capacity
Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
A submaximal cycle ergometer test performed to estimate maximal oxygen uptake
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Short-term change in work ability
Time Frame: Week 12 and 24
Work Ability Index questionnaire, short version
Week 12 and 24
Long-term change in work ability
Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Work Ability Index questionnaire, short version
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Long-term total sick leave change
Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Information about sick leave from registers at the Social Insurance Agency in Sweden
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Long-term cost-effectiveness
Time Frame: Week 12, 24 and 76, mixed model with several time points to estimate long-term effects
Estimation of Changes in Quality Adjusted Life Years by using the Short Form-(36) Health Survey
Week 12, 24 and 76, mixed model with several time points to estimate long-term effects

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Umeå University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Västerbotten County Council, Sweden
Swedish Social Insurance Agency

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lisbeth Slunga Järvholm, MD, Ass Prof, Umeå University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 8, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REHSAM 99368-2009/RS09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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