Clinical Trials Directory

Trials / Completed

CompletedNCT03073772

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
Phase
N/A
Study type
Interventional
Enrollment
161 (actual)
Sponsor
Umeå University · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
BEHAVIORALComputer-based cognitive trainingA 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.
BEHAVIORALPhysical fitness trainingA 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.

Timeline

Start date
2010-04-01
Primary completion
2014-12-31
Completion
2014-12-31
First posted
2017-03-08
Last updated
2017-03-08

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT03073772. Inclusion in this directory is not an endorsement.