- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04314921
10-week Yoga Practice Effect on Cognitive and Motor Function in Older Adults (BDNF)
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
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kaunas, Lithuania, 44221
- Lithuanian Sports Unviersity
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age, from 60 years old
- a statement by a local family physician about general good physical health
- never tired to practice yoga before
Exclusion Criteria:
- cardiovascular diseases
- musculoskeletal system diseases (osteoporosis, osteochondrosis, hernias)
- neurodegenerative diseases
- oncological diseases
- glaucoma
- injuries and surgeries in last 3 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 10-week Yoga
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.
|
10-week yoga sessions, 2 times per week, 90 min per session.
|
No Intervention: Control
In the control group, participants (n = 15) did not perform any exercises or other changes in their daily living life.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
10 weeks
|
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)
|
10 weeks
|
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
|
10 weeks
|
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)
|
10 weeks
|
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.
|
10 weeks
|
Psychomotor function evaluation
Time Frame: 10 weeks
|
Participants were assessed by Dynamic Parameter Analyzer (DPA-1).
Its measure motor functions: accuracy, reaction speed-accuracy.
|
10 weeks
|
Heart rate variability
Time Frame: 10 weeks
|
R-R intervals were recorded using a Polar H7 sensor with a chest strap (Kempele, Finland).
|
10 weeks
|
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).
|
10 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LithuanianSportsU-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aging
-
Tuba MadenCompletedAging | Aging Problems | Aging Disorder
-
Radboud University Medical CenterNot yet recruitingAging | Aging Well | Immuno Aging
-
University of Santiago de CompostelaEuropean Regional Development Fund; Center for Industrial Technological Development...Completed
-
TruDiagnosticBlushield USANot yet recruitingAging | Aging Well
-
San Diego State UniversityCompleted
-
Amazentis SAproDERM GmbHCompleted
-
University of West AtticaNot yet recruiting
-
University of Santiago de CompostelaAgencia Estatal de Investigación, SpainRecruiting
-
Beijing HospitalBGI-ShenzhenCompletedAging | Healthy Aging
-
Northumbria UniversityUniversity of East AngliaSuspendedSleep | Aging | Healthy AgingUnited Kingdom
Clinical Trials on Yoga trainings
-
University School of Physical Education in WroclawKessler Foundation; Wrocław University of Science and Technology; Nencki Institute... and other collaboratorsUnknown
-
Central Institute of Mental Health, MannheimCompletedNeuroplasticity | SensorimotorGermany
-
Prof. Dr. Dr. Thomas HilbergPfizerCompletedSports Physical Therapy | HaemophiliaGermany
-
Haramaya UnversityUniversity of Copenhagen; Leiden University Medical Center; Laerdal FoundationRecruitingObstetric Complication | Perinatal Death | Maternal Death | Stillbirth | Perinatal MorbidityEthiopia
-
Lithuanian Sports UniversityCompletedHealthy Aging | Cognitive Function | Motor LearningLithuania
-
Makerere UniversityCompleted
-
NYU Langone HealthCompletedDiabetes Prevention
-
University of California, San FranciscoNational Institute on Minority Health and Health Disparities (NIMHD); Florida...RecruitingSexually Transmitted Diseases | Human Immunodeficiency Virus | Human Immunodeficiency Virus TransmissionUnited States
-
Karadeniz Technical UniversityNot yet recruitingCardiopulmonary Resuscitation | Basic Life SupportTurkey
-
University of FloridaUnited States Agency for International Development (USAID)CompletedNutritionBurkina Faso