Physical activity impact on cognitive functions for patients with depressive disorder
| ISRCTN | ISRCTN91388658 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91388658 |
| Secondary identifying numbers | 1(V-5) |
- Submission date
- 13/02/2018
- Registration date
- 15/02/2018
- Last edited
- 15/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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)
Contact information
Scientific
Lithuanian Sports University
Sporto g. 6
Kaunas
44221
Lithuania
Study information
| Study design | Interventional randomised controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Physical activity impact on mental capacity for patients with depressive dissorder |
| Study objectives | The physical activity sessions (group exercises, strength exercises and active video games) can improve the cognitive functions of patients with depression. |
| Ethics approval(s) | Kaunas regional biomedical research ethics committee, 22/12/2017, ref: Nr. BE-2-18 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/06/2017 |
| Completion date | 23/02/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 90 |
| Key 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 |
| Key exclusion criteria | 1. Usual physical activity 2. Acute psychosis 3. Mental retardation 4. Have severe somatic disorder |
| Date of first enrolment | 23/12/2017 |
| Date of final enrolment | 30/03/2018 |
Locations
Countries of recruitment
- Lithuania
Study participating centre
LT-57164
Lithuania
Sponsor information
University/education
Sporto g. 6
Kaunas
LT-44221
Lithuania
"ROR" |
https://ror.org/00hxk7s55 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Aistė Leleikienė - digimaite@yahoo.com |
