Condition category
Mental and Behavioural Disorders
Date applied
13/02/2018
Date assigned
15/02/2018
Last edited
15/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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)

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Aiste Leleikiene

ORCID ID

Contact details

Lithuanian Sports University
Sporto g. 6
Kaunas
44221
Lithuania

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1(V-5)

Study information

Scientific title

Physical activity impact on mental capacity for patients with depressive dissorder

Acronym

Study hypothesis

The physical activity sessions (group exercises, strength exercises and active video games) can improve the cognitive functions of patients with depression.

Ethics approval

Kaunas regional biomedical research ethics committee, 22/12/2017, ref: Nr. BE-2-18

Study design

Interventional randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Depressive disorder

Intervention

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.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

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

01/06/2017

Overall trial end date

23/02/2019

Reason abandoned (if study stopped)

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

90

Participant exclusion criteria

1. Usual physical activity
2. Acute psychosis
3. Mental retardation
4. Have severe somatic disorder

Recruitment start date

23/12/2017

Recruitment end date

30/03/2018

Locations

Countries of recruitment

Lithuania

Trial participating centre

Kėdainiai Hospital
Kėdainiai
LT-57164
Lithuania

Sponsor information

Organisation

Lithuanian Sports University

Sponsor details

Sporto g. 6
Kaunas
LT-44221
Lithuania

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Lithuanian Sports University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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 - digimaite@yahoo.com

Intention to publish date

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes