NCT04314921

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

12 months

First QC Date

March 17, 2020

Last Update Submit

March 18, 2020

Conditions

Outcome Measures

Primary Outcomes (8)

  • 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

    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)

    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

    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)

    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.

    10 weeks

  • Psychomotor function evaluation

    Participants were assessed by Dynamic Parameter Analyzer (DPA-1). Its measure motor functions: accuracy, reaction speed-accuracy.

    10 weeks

  • Heart rate variability

    R-R intervals were recorded using a Polar H7 sensor with a chest strap (Kempele, Finland).

    10 weeks

  • Balance procedure

    Postural sway activity was measured by a posturography method with a single piezoelectric force plate (Kistler, Slimline System 9286, Switzerland).

    10 weeks

Study Arms (2)

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.

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.

Interventions

10-week yoga sessions, 2 times per week, 90 min per session.

10-week Yoga

Eligibility Criteria

Age60 Years - 76 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age, from 60 years old
  • a statement by a local family physician about general good physical health
  • never tired to practice yoga before

You may not qualify if:

  • cardiovascular diseases
  • musculoskeletal system diseases (osteoporosis, osteochondrosis, hernias)
  • neurodegenerative diseases
  • oncological diseases
  • glaucoma
  • injuries and surgeries in last 3 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lithuanian Sports Unviersity

Kaunas, 44221, Lithuania

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 19, 2020

Study Start

October 1, 2018

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

March 20, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations