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Rehabilitation for Improved Cognition

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03073772
Acronym
RECO
Enrollment
161
Registered
2017-03-08
Start date
2010-04-01
Completion date
2014-12-31
Last updated
2017-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burnout Syndrome, Exhaustion; Syndrome

Brief summary

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.

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).

Interventions

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.

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.

Sponsors

Västerbotten County Council, Sweden
CollaboratorOTHER_GOV
Swedish Social Insurance Agency
CollaboratorOTHER_GOV
Umeå University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Short-term change in global brain scoreWeek 12 and 24The global brain score was calculated from ten neuropsychological tasks covering different domains in cognitive functioning
Long-term change in global brain scoreWeek 12, 24 and 76, mixed model with several time points used to estimate long-term effectsThe global brain score was calculated from ten neuropsychological tasks covering different domains in cognitive functioning

Secondary

MeasureTime frameDescription
Short-term change in letter memory running span taskWeek 12 and 24A measure of the updating functioning
Long-term change in letter memory running span taskWeek 12, 24 and 76, mixed model with several time points used to estimate long-term effectsA measure of the updating functioning
Short-term change in 3-back taskWeek 12 and 24A measure of the updating functioning
Long-term change in 3-back taskWeek 12, 24 and 76, mixed model with several time points used to estimate long-term effectsA measure of the updating functioning
Short-term change in the colour word interference test (the Stroop test)Week 12 and 24A measure of the inhibition functioning, from D-KEFS
Long-term change in the colour word interference test (the Stroop test)Week 12, 24 and 76, mixed model with several time points to estimate long-term effectsA measure of the inhibition functioning, from D-KEFS
Short-term change in the trail making testWeek 12 and 24A measure of attentional shifting, from D-KEFS
Long-term change in the trail making testWeek 12, 24 and 76, mixed model with several time points to estimate long-term effectsA measure of attentional shifting, from D-KEFS
Short-term change in the digit span forward testWeek 12 and 24A measure of the working memory, from WAIS-R
Long-term change in the digit span forward testWeek 12, 24 and 76, mixed model with several time points to estimate long-term effectsA measure of the working memory, from WAIS-R
Short-term change in the digit span backward testWeek 12 and 24A measure of the working memory, from WAIS-R
Long-term change in the digit span backward testWeek 12, 24 and 76, mixed model with several time points to estimate long-term effectsA measure of the working memory, from WAIS-R
Short-term change in the letter-number sequencing testWeek 12 and 24A measure of the working memory, from WAIS-III
Long-term change in the letter-number sequencing testWeek 12, 24 and 76, mixed model with several time points to estimate long-term effectsA measure of the working memory, from WAIS-III
Short-term change in the recall of concrete nouns test (Buschke's selective reminding procedure)Week 12 and 24A measure of the episodic memory
Long-term change in the recall of concrete nouns test (Buschke's selective reminding procedure)Week 12, 24 and 76, mixed model with several time points to estimate long-term effectsA measure of the episodic memory
Short-term change in the digit symbol testWeek 12 and 24A measure of perceptual speed, from WAIS-R
Long-term change in the digit symbol testWeek 12, 24 and 76, mixed model with several time points to estimate long-term effectsA measure of perceptual speed, from WAIS-R
Short-term change in Raven's advanced progressive matricesWeek 12 and 24A measure of non-verbal reasoning ability
Long-term change in Raven's advanced progressive matricesWeek 12, 24 and 76, mixed model with several time points to estimate long-term effectsA measure of non-verbal reasoning ability
Short-term change in Shirom Melamed Burnout QuestionnaireWeek 12 and 24A burnout measure
Long-term change in Shirom Melamed Burnout QuestionnaireWeek 12, 24 and 76, mixed model with several time points to estimate long-term effectsA burnout measure
Short-term change in Short Form 36 item Health QuestionnaireWeek 12 and 24Health-related quality of life estimate
Long-term change in Short Form 36 item Health QuestionnaireWeek 12, 24 and 76, mixed model with several time points to estimate long-term effectsHealth-related quality of life estimate
Short-term change in Checklist Individual Strength QuestionnaireWeek 12 and 24Measure of fatigue
Long-term change in Checklist Individual Strength QuestionnaireWeek 12, 24 and 76, mixed model with several time points to estimate long-term effectsMeasure of fatigue
Short-term change in Hospital Anxiety and Depression Scale, HAD-SWeek 12 and 24A measure of anxiety and depression
Long-term change in Hospital Anxiety and Depression Scale, HAD-SWeek 12, 24 and 76, mixed model with several time points to estimate long-term effectsA measure of anxiety and depression
Short-term change in aerobic capacityWeek 12 and 24A submaximal cycle ergometer test performed to estimate maximal oxygen uptake
Long-term change in aerobic capacityWeek 12, 24 and 76, mixed model with several time points to estimate long-term effectsA submaximal cycle ergometer test performed to estimate maximal oxygen uptake
Short-term change in work abilityWeek 12 and 24Work Ability Index questionnaire, short version
Long-term change in work abilityWeek 12, 24 and 76, mixed model with several time points to estimate long-term effectsWork Ability Index questionnaire, short version
Long-term total sick leave changeWeek 12, 24 and 76, mixed model with several time points to estimate long-term effectsInformation about sick leave from registers at the Social Insurance Agency in Sweden
Long-term cost-effectivenessWeek 12, 24 and 76, mixed model with several time points to estimate long-term effectsEstimation of Changes in Quality Adjusted Life Years by using the Short Form-(36) Health Survey

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026