Yoga and Diet on Cognitive, Nutritional Status, Mental and Functional Abilities in Older Adults

October 18, 2024 updated by: Agustín Aibar Almazán, University of Jaén

Effects of a Yoga Program Combined With Diet on Cognitive, Nutritional Status, Mental and Functional Abilities in Older Adults.

Yoga has emerged as a powerful therapeutic practice for enhancing physical and mental health across all age groups, including older adults and younger individuals. For seniors, yoga aids in maintaining flexibility, muscle strength, balance, and posture, thereby reducing the risk of falls and injuries. It also alleviates chronic pain, enhances sleep quality, and mitigates stress and anxiety, contributing to improved overall mental and emotional well-being in this demographic. As individuals age, they undergo physical and mental changes that impact their quality of life. Yoga offers tailored benefits for older adults by preserving joint mobility and flexibility, lowering the risk of falls, and easing chronic pain associated with conditions like arthritis and osteoporosis. Moreover, it fosters stress reduction, anxiety relief, and depression mitigation, fostering emotional equilibrium. The practice of yoga from a young age yields numerous advantages for both physical and mental health, including enhanced concentration, attention, and memory-beneficial qualities for university students. Moreover, yoga aids in stress and anxiety reduction, fosters positive body image, and bolsters self-esteem, contributing to vitality and active aging. Yoga is efficacious in enhancing quality of life and facilitating healthy aging by offering adaptable, gentle exercise that caters to individual needs and limitations. Its mindfulness and body awareness aspects foster a stronger mind-body connection, fostering overall well-being and balance. With its adaptability and accessibility, yoga transcends socioeconomic barriers and physical conditions, making it a viable option for people of all backgrounds. In a society marked by rising stress and lifestyle-related ailments, yoga emerges as an invaluable therapeutic avenue for promoting health and well-being. Its holistic approach and adaptability to individual needs make it an appealing option for individuals seeking sustainable improvements in physical and mental health. Thus, the integration and promotion of yoga as a therapeutic modality in health and wellness domains are warranted. Also, Nutrition plays a fundamental role in the health and well-being of individuals at all stages of life, but it is especially crucial in old age due to the physiological and metabolic changes that occur during the aging process. Maintaining a healthy and balanced diet is essential for providing the necessary nutrients for proper body function, strengthening the immune system, and maintaining the health of bone and cardiovascular structures. Specifically, the Mediterranean diet is a traditional dietary pattern based on foods commonly consumed in Mediterranean regions such as Greece, Italy, and Spain. It is characterized by high consumption of fruits, vegetables, legumes, nuts, whole grains, fish, and olive oil, along with moderate intake of dairy and red wine, and limited con-sumption of red meat and processed products. This eating style has been the subject of numerous scientific studies highlighting its multiple health benefits. Apart from the physical health benefits for older adults, the Mediterranean diet has consistently been associated with positive effects such as reduced risk of cardiovascular pathologies, de-creased chronic diseases and pro-inflammatory factors, as well as contributing to the prevention of obesity and cognitive decline.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Jaén, Spain, 23007
        • Agustín Aibar Almazán

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

To participate in the study, participants will be required to:

  • Who are over 65 years old.
  • Who do not participate in any physical exercise program.
  • Have sufficient physical autonomy to participate in the physical activities required by the study and are able to understand the instructions, programs and protocols of this project.

Exclusion Criteria:

  • All participants with contraindications for performing the physical tests will be excluded.
  • Diseases that limit cognitive performance and physical activity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
The control group (CG) will not undergo treatment, which will be evaluated in the pre- and post-phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity, and they will be given the guide of recommendations for the promotion of physical activity.
Experimental: Experimental Group
The experimental group (EG), after an initial evaluation, will be subjected to a physical training program based on the yoga method, for 12 weeks with 2 weekly sessions (Tuesday and Thursday), with a duration of 45 minutes per session. Once the intervention is finished, you will undergo a final evaluation again to see if there is a difference or not with the results obtained at the beginning. In addition to the yoga intervention, the experimental group received a Mediterranean diet protocol.
Other: Yoga and Mediterranean Diet intervention

It will last 12 weeks with a frequency of 2 sessions per week and each lasting 50 minutes.

  • Warm-up phase (10 minutes): Conscious and gentle breathing. Gentle movements of the neck, shoulders, arms and legs to increase blood circulation and flexibility.
  • Training phase (30 minutes): Series of gentle postures adapted to the needs of older adults. Includes standing, sitting and lying postures for relaxation and stretching. It will begin with basic postures and breathing techniques and will gradually advance as participants gain confidence.
  • Return to calm (10 minutes): Deep relaxation in a lying position to integrate the benefits of the practice and promote total relaxation of the body and mind.

The Mediterranean diet consisted of: i) carbohydrates constitute 50% of the daily intake; ii) fats represented 35%; and iii) proteins represented 15%.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Handgrip Strength
Time Frame: Up to twelve weeks
Dynamometer will be employed to assess hand grip strength.
Up to twelve weeks
Sleep quality
Time Frame: Up to twelve weeks
Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 self-assessment questions or items and 5 more to be completed by the person with whom the participant shares a bed or room (although the latter is only used to provide clinical information). These items generate a total score and 7 components or domains: sleep quality; sleep latency; sleep duration; sleep efficiency; sleep disorders; use of sleeping medications; daytime dysfunction. The PSQI total score ranges from 0 to 21, with a higher score indicating poorer sleep quality.
Up to twelve weeks
TMT (Trail Making Test)
Time Frame: Up to twelve weeks
It is used to assess executive function. It measures timed motor and visual tasks, and is divided into two tests: Part A (TMTA), which assesses speed and psychomotor attention and requires connecting consecutively numbered circles; and Part B (TMTB), which tests executive function and requires connecting alternating circles of numbers and letters. Longer completion times indicate poor performance.
Up to twelve weeks
SFT (Senior Fitness Test)
Time Frame: Up to twelve weeks
Instrument used to assess functional abilities. It consists of the following tests: muscle strength (upper and lower limbs), aerobic endurance, flexibility (upper and lower limbs) and agility, 6-minute walk test, Sit-to-foot test using a chair (measures flexibility of the lower body, Try to clasp hands behind your back, Try to get up, walk 8 feet and sit back.
Up to twelve weeks
Mindful Attention Awareness Scale (MAAS)
Time Frame: Up to twelve weeks
It evaluates, in a global way, the dispositional capacity of an individual to be attentive and aware of the experience of the present moment in everyday life. The scale is a 15-item univariate self-report with a view of the mindfulness construct centered on the attention / consciousness variable.
Up to twelve weeks
Anxiety and Depression
Time Frame: Up to twelve weeks
Hospital Anxiety and Depression Scale (HADS). This scale consists of 14 items with 4 response alternatives ranging from 0 to 3 for a total of 0 to 21 points. It has 2 subscales and the score is obtained by adding the scores of each item that make it up, the interpretation criteria being the following: Range of normality (0-7), Possible case of anxiety or depression (8-10) and Case of anxiety or depression (11-21).
Up to twelve weeks
Digit symbol substitution test (DSST)
Time Frame: Up to twelve weeks
Paper-and-pencil cognitive test presented on a single sheet of paper that requires a subject to match symbols to numbers according to a key located at the top of the page. The subject copies the symbol in spaces below a row of numbers. The number of correct symbols within the time allowed, usually 90 to 120 seconds, constitutes the score.
Up to twelve weeks
D2 test
Time Frame: Up to twelve weeks
The test measures the speed of processing, the following of instructions and the goodness of execution in a task of discrimination of similar visual stimuli and which, therefore, allow the estimation of attention and concentration. The resulting scores are: - TR, total responses: number of elements attempted in the 14 lines. - TA, total correct answers: number of relevant elements correct. - Or, omissions: numbers of relevant elements attempted but not marked. - C, commissions: number of irrelevant elements marked. - TOT, total effectiveness in the test, that is, TR-(O+C). - CON, concentration index or TA-C. - TR+, line with the highest number of elements attempted. - TR-, line with the lowest number of elements attempted. - VAR, variation or difference index (TR+)-(TR-). The D2 is a useful instrument in research showing a high degree of validity and reliability.
Up to twelve weeks
Isaac test
Time Frame: Up to twelve weeks
Participants have 60 seconds to generate as many words as possible within a given semantic category (animals, colors, fruits, and cities). The maximum score is 40 points (with a maximum of 10 per category). The higher the score, the better the level of verbal fluency.
Up to twelve weeks
Balance
Time Frame: Up to twelve weeks
The Tinetti scale was used to measure physical variables of balance, gait, and fall risk [38,39]. This scale is divided into two parts, one measuring static and dynamic balance with 9 items and a maximum score of 17 points, and another measuring gait with 7 items, with a highest score of 12 points. The sum of the two parts is used to assess fall risk. A higher score indicates a lower risk of falling, with 29 being the maximum score achievable. Scores between 19 and 24 points indicate a risk of falls, while scores below 19 indicate low risk.
Up to twelve weeks
Nutritional status
Time Frame: Up to twelve weeks
Changes in participants' nutritional status were assessed using the Mini Nutritional As-sessment (MNA), which is a validated tool for detecting and evaluating malnutrition and the risk of malnutrition in older adults (≥65 years). It consists of 18 questions divided into 4 domains: anthropometric assessment (weight, height, BMI, and arm and calf circum-ferences), global assessment (lifestyle, medication, and mobility), dietary assessment (number of meals and food and liquid intake), and subjective perception of health and nutrition. Each item has a numerical value, and the total score has a maximum value of 30. The MNA classifies nutritional status as adequate (score of 24 to 30), at risk of malnutrition (score of 17 to 23.5), and poor (score less than 17).
Up to twelve weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Jaén

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 5, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • University of Jaén_24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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