Plain English Summary
Background and study aims
Depressive symptom are associated with poor cognitive function (mental capacity) and subsequent cognitive decline. Physical activity may be one of multiple therapies for improvement, maintenance and development of cognitive functions. The aim of this study is to evaluate the effect of group exercising on mood and cognitive functions in persons with depression.
Who can participate?
Adults aged 25-80 years who are diagnosed with depression disorder.
What does the study involve?
Participants are randomly allocated to one of four groups. Those in the first group receive physical activity sessions three times a week. Those in the second group receive physical activity sessions three times a week. Participants in the third group participate in the active video games physical activity session three times a week. Participants in the first three groups have their cognitive function measured before and after the programme. Those in the last group only have their cognitive function measured at the same times of the other groups.
What are the possible benefits and risks of participating?
There are direct benefit of participating in the research because participants will have acute improvement of the mood after each session and better thinking and attention possibilities (cognitive functions) after 4weeks. There are no direct risks with participating.
Where is the study run from?
Kėdainiai Hospital (Lithuania)
When is the study starting and how long is it expected to run for?
June 2017 to February 2019
Who is funding the study?
Lithuanian Sports University (Lithuania)
Who is the main contact?
Mrs Aiste Leleikiene (Scientific)
Physical activity impact on mental capacity for patients with depressive dissorder
The physical activity sessions (group exercises, strength exercises and active video games) can improve the cognitive functions of patients with depression.
Kaunas regional biomedical research ethics committee, 22/12/2017, ref: Nr. BE-2-18
Interventional randomised controlled study
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Participants are randomly allocated to one of four groups during hospitalisation:
First group: Participants are asked to participate in the group physical activity sessions (durations 45 minutes, 3 times a week). Cognitive functions are evaluated before and after 12 sessions of physical activity.
Second group: Participants are asked to participate in the strength physical activity sessions (durations 45 minutes, 3 times a week). Cognitive functions are evaluated before and after 12 sessions of physical activity.
Third group: Participants are asked to participate in the active video games physical activity sessions (durations 45 minutes, 3 times a week). Cognitive functions are evaluated before and after 12 sessions of physical activity.
Control group: Participants are asked to participate in the trial, and their cognitive functions are evaluated two times (first day and after 4 weeks).
Participants are followed up to measure their cognitive function before the intervention and after four weeks.
Primary outcome measures
Cognitive function is measured using the computerized automated neuropsychological assessment metrics version (ANAM4 ™ TBI Battery) at baseline and 4 weeks.
Secondary outcome measures
1. Mood is measured using Yvesage geriatric scale at baseline and 4 weeks
2. Level of physical activity measured using Modified Baecke Questionnaire at baseline
3 Mood measured using visual analogue scale at before and after each physical activity session
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Diagnosed depression disorder
2. Don't have usual physical activity
3. Don't have acute psychosis
4. Don't have mental retardation
5. Don't have severe somatic disorder
6. Aged between 25-80 years old
Target number of participants
Participant exclusion criteria
1. Usual physical activity
2. Acute psychosis
3. Mental retardation
4. Have severe somatic disorder
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Lithuanian Sports University
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal. The protocol and statistical analysis plan is in Lithuanian language and can be sent upon request.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Aistė Leleikienė - email@example.com
Intention to publish date
Participant level data
Available on request
Results - basic reporting