NCT06189430

Brief Summary

During the aging process, concrete changes such as loss of function in organs and systems resulting from biological, physiological and psychological negativities and difficulty in participating in daily life activities occur. Frailty, one of the geriatric syndromes, is a complex condition that increases vulnerability to stressors and causes a decrease in the physiological reserve necessary to maintain homeostasis in most organs. When examined pathophysiologically, it is thought that frailty is not only evaluated as physical, but psychological and social fragility may also contribute to this situation. It is thought that physical activity that includes strength training to maintain or improve muscle mass throughout aging may reduce muscle loss, an important risk factor for frailty. To treat physical frailty, supervised exercise is recommended as an effective strategy. Yoga; It is a holistic practice that encourages healing through breathing, movement, strength, flexibility and achieving integrity of spirit, body and mind. Being a meditative practice distinguishes yoga from other typical forms of physical exercise, despite having similar metabolic intensity. Regular yoga has the potential to improve flexibility, balance and muscle strength in older individuals. It is also known that yoga improves cognitive function in the elderly, helps manage chronic conditions, reduces pain due to osteoarthritis, improves sleep, increases subjective well-being and health-related quality of life. During the healthy aging process, people may need to be guided according to their individual and health characteristics. By supporting this situation with appropriate nursing care, losses can be reduced and optimum health can be maintained. One of the biggest advantages of yoga applied within the scope of nursing care is that the individual's progress is ensured in a controlled manner by preparing a flow in line with appropriate asana selections, taking into account the individual's health condition. Nursing, by its nature, requires a holistic approach to people. Similarly, the practice of yoga is considered a practice that integrates not only physical health but also the mind, body and soul. This study was planned as a randomized controlled, double-blind and experimental study to evaluate the effect of vinyasa yoga on frailty and anthropometric measurements in elderly individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2023

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

December 6, 2023

Last Update Submit

December 19, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Groningen Frailty Index

    "Groningen Frailty Scale" is a scale used to identify frail elderly individuals.The Cronbach's alpha coefficient of the scale was found to be 0.72.GFI is a 15-item screening tool that measures physical, cognitive, psychosocial and polypharmacy frailty in the form of professional and self-report to determine the level of frailty. Eight items have two response categories (yes / no), six items have three response categories (yes / sometimes / no), and one item has a Likert type response category (1-10). A high GFI total score indicates a high level of frailty. The total score obtained from the scale varies between 0 and 15, and higher scores indicate more fragility. The answer to each item has 0 or 1 point; 1 indicates a problem with vulnerability and fondness.

    Repeated measurements were made; Groningen Frailty Scale 0.,4.,8. and at the end of the 12. week, it was done 4 times in total.

  • Skeletal muscle and appendicular muscle mass measurement from anthropometric (physiological parameter) measurements with Bioelectrical Impedance Analysis

    It is the measurement of tissues in the body, such as muscle and fat, which are rich in liquid electrolytes, with a portable device. Although there is no direct tissue measurement, accurate results can be achieved within the framework of certain standards that affect the conductivity state.With BIA measurements, skeletal muscle mass (Skeletal Muscle Mass = SMM), appendicular muscle mass (Apendicular skeletal muscle mass = ASM) and the indices SMI and ASMI, which are formed by dividing the square meter of these measurements to the height, can be measured. ASM is 15 kg and above in a healthy adult woman; For men, it should be 20 kg and above. For ASMI, 7 kg/m2 and above in men and 5.5 kg/m2 and above in women are considered normal values. Both low muscle strength and low muscle mass suggest a diagnosis of sarcopenia in individuals.

    These measurements were applied as pretest and posttest. It was applied at week 0 and week 12.

  • Hand Grip Test

    The isokinetic dynamometer measurement test, which is considered the gold standard in the evaluation of muscle strength, is performed by examining the highest force realized with the flexion of all hands and fingers under biokinetic conditions.

    These measurements were applied as pretest and posttest. It was applied at week 0 and week 12.

  • 4-Meter Walk Gait Speed Test

    In the 4 meter walking test; The individual is expected to walk a distance of 4 meters in less than 5 seconds.

    These measurements were applied as pretest and posttest. It was applied at week 0 and week 12.

Study Arms (2)

Yoga Group

EXPERIMENTAL

Individuals in the yoga group of the study had 10 minutes of meditation, 10 minutes of warm-up, and 40 minutes of vinyasa yoga practice, 2 days a week face-to-face and 1 day online, for a total of 12 weeks.Yoga practice was standardized throughout the study to avoid the risk of intervention variability. The basic structure of each yoga session is meditation, breathing exercises (pranayama), and after a warm-up, yoga practice includes asanas (postures) for strength, balance and mobility, and finally ends with relaxation.

Other: Yoga

Control Group

ACTIVE COMPARATOR

In order to better understand the effectiveness of Vinyasa yoga, individuals in the control group will perform moderate-intensity standard exercise (50-70% MHR: maximum pulse rate) for the same duration and at the same hours.

Other: Standard exercise

Interventions

YogaOTHER

Yoga practice was standardized throughout the study to avoid the risk of intervention variability. The basic structure of each yoga session is meditation, breathing exercises (pranayama), and after a warm-up, yoga practice includes asanas (postures) for strength, balance and mobility, and finally ends with relaxation. The yoga intervention we recommend was created within the framework of the asanas that the elderly can do in the literature and by taking the expert opinion of a sports physician.

Also known as: Vinyasa Yoga
Yoga Group

It is a type of exercise similar in intensity to vinyasa yoga. (50-70% MHR: maximum pulse rate)

Control Group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • A student at Ege 3rd Age University
  • Those who are between the ages of 65-85,
  • Agreeing to participate in the research,
  • Open to communication,
  • Those with a score of 25 or above according to the mini mental test

You may not qualify if:

  • Those who are older than 85 and younger than 65,
  • Have been meditating regularly in the last year,
  • Having attended a 200-hour yoga training program and previously received a certificate,
  • Having a chronic disease that will prevent/limit yoga, such as COPD, Asthma, Coronary
  • Artery Disease, Heart Failure, and create exercise restrictions.
  • Having had a Mini Mental Test within 15 days
  • Known history of neoplasia and/or being in the treatment process,
  • Having advanced rheumatic or muscular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Related Publications (6)

  • Lau C, Yu R, Woo J. Effects of a 12-Week Hatha Yoga Intervention on Metabolic Risk and Quality of Life in Hong Kong Chinese Adults with and without Metabolic Syndrome. PLoS One. 2015 Jun 25;10(6):e0130731. doi: 10.1371/journal.pone.0130731. eCollection 2015.

  • DiBenedetto M, Innes KE, Taylor AG, Rodeheaver PF, Boxer JA, Wright HJ, Kerrigan DC. Effect of a gentle Iyengar yoga program on gait in the elderly: an exploratory study. Arch Phys Med Rehabil. 2005 Sep;86(9):1830-7. doi: 10.1016/j.apmr.2005.03.011.

  • Ni M, Mooney K, Richards L, Balachandran A, Sun M, Harriell K, Potiaumpai M, Signorile JF. Comparative impacts of Tai Chi, balance training, and a specially-designed yoga program on balance in older fallers. Arch Phys Med Rehabil. 2014 Sep;95(9):1620-1628.e30. doi: 10.1016/j.apmr.2014.04.022. Epub 2014 May 14.

  • Pina AA, Shadiow J, Tobi Fadeyi A, Chavez A, Hunter SD. The acute effects of vinyasa flow yoga on vascular function, lipid and glucose concentrations, and mood. Complement Ther Med. 2021 Jan;56:102585. doi: 10.1016/j.ctim.2020.102585. Epub 2020 Oct 7.

  • Miller SM, Hui-Lio C, Taylor-Piliae RE. Health Benefits of Tai Chi Exercise: A Guide for Nurses. Nurs Clin North Am. 2020 Dec;55(4):581-600. doi: 10.1016/j.cnur.2020.07.002. Epub 2020 Oct 13.

  • Shin S. Meta-Analysis of the Effect of Yoga Practice on Physical Fitness in the Elderly. Int J Environ Res Public Health. 2021 Nov 6;18(21):11663. doi: 10.3390/ijerph182111663.

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Meltem Adaiçi, PhD Student

    Ege University

    PRINCIPAL INVESTIGATOR
  • Nazmiye Çıray, Asst. Prof.

    Ege University

    STUDY DIRECTOR
  • Fisun Şenzun Aykar, Prof.

    Izmir Tinaztepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Research data were collected by one-on-one and face-to-face interviews using data collection tools and the statistician was blinded. Hrobjartsson et al. (2013) report that blinding the person performing the statistical analysis, which is frequently preferred in non-pharmaceutical research, has positive effects in terms of reducing bias in effect size estimates and is also useful if the measurements are subjective. It is emphasized that blinding those who measure subjective data, which can only be obtained from the individual and which generally constitute the main criteria of nursing studies, is a feasible and preferable method. For this reason, the data in our study was collected by another research assistant outside the study. For all tests performed, individuals were given nicknames and data entries were made.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study was planned as a randomized controlled, double-blind and experimental study to evaluate the effect of vinyasa yoga on frailty and anthropometric measurements in elderly individuals.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2023

First Posted

January 3, 2024

Study Start

March 8, 2023

Primary Completion

May 24, 2023

Study Completion

June 1, 2023

Last Updated

January 3, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Since it is a doctoral thesis study, it will be shared at the Turkish Higher Education Institution National Thesis Center when the thesis process is completed.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
It can be used in accordance with the time it was published in the Turkish National Thesis Center (YÖKTEZ).
Access Criteria
It is available as of the time it is published in the Turkish National Thesis Center (YÖKTEZ).
More information

Locations