AgingBDNFNCT04314921
10-week Yoga Practice Effect on Cognitive and Motor Function in Older Adults
A study testing Yoga trainings in people with Aging and Healthy Aging, run by Lithuanian Sports University at 1 site in Lithuania.
Trial summary
Thirty-three healthy elderly people, who were classified into two age groups, participated in this study. All participants had not practiced yoga before and were asked not to perform any sports activities while the research was ongoing. Read more about this study
- Who is it for?
- Ages 60 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Healthy Aging
- What is being tested?
- Yoga trainings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Oct 2018to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age, from 60 years old
- a statement by a local family physician about general good physical health
- never tired to practice yoga before
Who cannot join
- cardiovascular diseases
- musculoskeletal system diseases (osteoporosis, osteochondrosis, hernias)
- neurodegenerative diseases
- oncological diseases
- glaucoma
- injuries and surgeries in last 3 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 10-week Yoga Practice Effect in Older Adults
Thirty-three healthy elderly people, who were classified into two age groups, participated in this study. All participants had not practiced yoga before and were asked not to perform any sports activities while the research was ongoing. In the experimental group, participants (n = 18) had to participate in 10 weeks of yoga classes. In the control group, participants (n = 15) did not perform any exercises or other changes in their daily living life.
Experimental measurements: Brunel, PSS-14 and HAD questionnaires
- Conditions
- Aging, Healthy Aging
- Being tested
- Yoga trainings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga trainingsOther
10-week yoga sessions, 2 times per week, 90 min per session.
| Study group | Role | What they receive |
|---|---|---|
| 10-week Yoga | Experimental | Eighteen healthy elderly people, who were classified into two age groups, participated in this study. All participants had not practiced yoga before and were asked not to perform any sports activities while the research was ongoing. In the experimental group, participants (n = 18) had to participate in 10 weeks of yoga classes. In the control group, participants (n = 15) did not perform any exercises or other changes in their daily living life. All experimental group subjects participated in Himalayan yoga classes, which lasted 10 weeks: 2 times per week, 90 min per session. Yoga classes were conducted by 16-year-old qualified yoga instructor from Yoga Academy, Kaunas. Receives: Other: Yoga trainings |
| Control | No intervention | In the control group, participants (n = 15) did not perform any exercises or other changes in their daily living life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brunel mood scale (BRUMS)
The Lithuanian translated version of the Brunel Mood Scale (BRUMS) was used in the present study. It was based on the originally developed to serve as a brief measure of mood before and after yoga intervention. The BRUMS (1) scale has 24 items arranged into six subscales: anger, confusion, depression, fatigue, tension and vigor. Each subscale has a numerical rating scale (0 = not at all, 1 = a bit, 2 = moderate, 3 = enough; 4 = extremely) from which research participant select the one best represents at that time. The results within subscale is summed and a score range from 0 to 16
Measured: 10 weeks
Hospital anxiety and depression scale (HADS)
To determine the level of anxiety and depression of subjects was used HADS scale. The scale consists of totally 14 questions with the answers valued from 0 to 3. Half of questions addressed to estimate anxiety and rest - depression. The total scoring and conclusion for the both categories of questions: 0-7 = Normal; 8-10 = Borderline abnormal (borderline case); 11-21 = Abnormal (case)
Measured: 10 weeks
Perceived stress scale -14
The purpose of this scale is to assess the degree of stress in subjects' lives. It consists of questions about the frequency of feeling and thoughts during the past time period. Potential answers: 0-never; 1-almost never; 2-sometimes; 3-fairly often and 4-very often. The scores are obtained by reversing the scores on the four positive items: for example, 0=4, 1=3, 2=2, etc. and then summing across all items. Scores for the 14-item form range from 0 to 56, with higher scores indicating greater perceived stress
Measured: 10 weeks
Human Free BDNF
Venous blood samples from median antecubital vein were collected in 5 ml vacuum tubes with a gel separator and was separated by centrifugation (15 min at 1200g) to make blood serum. Samples were aliquoted and stored at -800C until analysis. The serum concentration of Human Free BDNF was measured using an enzyme-linked immunoassay kit (R\&D Systems, Minneapolis, USA)
Measured: 10 weeks
Measurement of cognitive functions
Automated Neuropsychological Assessment Metrics Version 4 (ANAM-4; Vista Life, USA) was used to measure neurocognitive skills: mental flexibility, verbal working memory, inhibition control, visuospatial processing.
Measured: 10 weeks
Psychomotor function evaluation
Participants were assessed by Dynamic Parameter Analyzer (DPA-1). Its measure motor functions: accuracy, reaction speed-accuracy.
Measured: 10 weeks
Heart rate variability
R-R intervals were recorded using a Polar H7 sensor with a chest strap (Kempele, Finland).
Measured: 10 weeks
Balance procedure
Postural sway activity was measured by a posturography method with a single piezoelectric force plate (Kistler, Slimline System 9286, Switzerland).
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start1 Oct 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian Sports University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314921
- Sponsor's protocol ID
- LithuanianSportsU-3
- Acronym
- BDNF
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 10-week Yoga Practice Effect in Older Adults
- ClinicalTrials.gov ID
- NCT04314921
- Acronym / sponsor ID
- BDNF / LithuanianSportsU-3
- Conditions
- Aging, Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Lithuanian Sports UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thirty-three healthy elderly people, who were classified into two age groups, participated in this study. All participants had not practiced yoga before and were asked not to perform any sports activities while the research was ongoing. In the experimental group, participants (n = 18) had to participate in 10 weeks of yoga classes. In the control group, participants (n = 15) did not perform any exercises or other changes in their daily living life.
Experimental measurements: Brunel, PSS-14 and HAD questionnaires
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10-week Yoga | Experimental | Other: Yoga trainingsEighteen healthy elderly people, who were classified into two age groups, participated in this study. All participants had not practiced yoga before and were asked not to perform any sports activities while the research was ongoing. In the experimental group, participants (n = 18) had to participate in 10 weeks of yoga classes. In the control group, participants (n = 15) did not perform any exercises or other changes in their daily living life. All experimental group subjects participated in Himalayan yoga classes, which lasted 10 weeks: 2 times per week, 90 min per session. Yoga classes were conducted by 16-year-old qualified yoga instructor from Yoga Academy, Kaunas. |
| Control | No intervention | –In the control group, participants (n = 15) did not perform any exercises or other changes in their daily living life. |
Who may qualify
- Ages
- 60 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age, from 60 years old
- a statement by a local family physician about general good physical health
- never tired to practice yoga before
Key exclusion criteria (6 listed)
- cardiovascular diseases
- musculoskeletal system diseases (osteoporosis, osteochondrosis, hernias)
- neurodegenerative diseases
- oncological diseases
- glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga trainings10-week yoga sessions, 2 times per week, 90 min per session. | Other | 10-week Yoga |
Primary outcome
Brunel mood scale (BRUMS)
Time frame: 10 weeks
The Lithuanian translated version of the Brunel Mood Scale (BRUMS) was used in the present study. It was based on the originally developed to serve as a brief measure of mood before and after yoga intervention. The BRUMS (1) scale has 24 items arranged into six subscales: anger, confusion, depression, fatigue, tension and vigor. Each subscale has a numerical rating scale (0 = not at all, 1 = a bit, 2 = moderate, 3 = enough; 4 = extremely) from which research participant select the one best represents at that time. The results within subscale is summed and a score range from 0 to 16
Hospital anxiety and depression scale (HADS)
Time frame: 10 weeks
To determine the level of anxiety and depression of subjects was used HADS scale. The scale consists of totally 14 questions with the answers valued from 0 to 3. Half of questions addressed to estimate anxiety and rest - depression. The total scoring and conclusion for the both categories of questions: 0-7 = Normal; 8-10 = Borderline abnormal (borderline case); 11-21 = Abnormal (case)
Perceived stress scale -14
Time frame: 10 weeks
The purpose of this scale is to assess the degree of stress in subjects' lives. It consists of questions about the frequency of feeling and thoughts during the past time period. Potential answers: 0-never; 1-almost never; 2-sometimes; 3-fairly often and 4-very often. The scores are obtained by reversing the scores on the four positive items: for example, 0=4, 1=3, 2=2, etc. and then summing across all items. Scores for the 14-item form range from 0 to 56, with higher scores indicating greater perceived stress
Human Free BDNF
Time frame: 10 weeks
Venous blood samples from median antecubital vein were collected in 5 ml vacuum tubes with a gel separator and was separated by centrifugation (15 min at 1200g) to make blood serum. Samples were aliquoted and stored at -800C until analysis. The serum concentration of Human Free BDNF was measured using an enzyme-linked immunoassay kit (R\&D Systems, Minneapolis, USA)
Measurement of cognitive functions
Time frame: 10 weeks
Automated Neuropsychological Assessment Metrics Version 4 (ANAM-4; Vista Life, USA) was used to measure neurocognitive skills: mental flexibility, verbal working memory, inhibition control, visuospatial processing.
Psychomotor function evaluation
Time frame: 10 weeks
Participants were assessed by Dynamic Parameter Analyzer (DPA-1). Its measure motor functions: accuracy, reaction speed-accuracy.
Heart rate variability
Time frame: 10 weeks
R-R intervals were recorded using a Polar H7 sensor with a chest strap (Kempele, Finland).
Balance procedure
Time frame: 10 weeks
Postural sway activity was measured by a posturography method with a single piezoelectric force plate (Kistler, Slimline System 9286, Switzerland).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga trainings in people with Aging and Healthy Aging, run by Lithuanian Sports University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brunel mood scale (BRUMS) (time frame: 10 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.