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Sarcopenia, Active Aging and Oral Microbiota. Effects of HIIT in Older Adults

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
HIIT
MICT
Sponsored by
University of Jaén
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 65 years
  • SARC-F ≥4 or handgrip strength <16 kg for women and < 27 kg for men.
  • Not being afflicted by any condition preventing physical activity.
  • Not being engaged in regular physical activity >20 minutes and >3 days/week.
  • Being able to communicate without difficulty.
  • Being able to read and understand the informed consent form as well as the goals of the study.

Exclusion Criteria:

  • Acute or terminal illness.
  • Unstable cardiovascular conditions.
  • Conditions or medical treatments affecting the normal production of saliva (i.e. autoimmune disorders such as Sjögren's syndrome or medications like anxiolytics or antidepressants).
  • Being or having been medicated with antibiotics up to one month prior to the taking of samples.
  • Alcohol abuse or regular drug abuse.
  • Severe visual or auditory impairment.
  • Being involved in a different research group with the potential to interfere in our results.

Sites / Locations

  • Andina Area University Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

HIIT Group

MICT Group

Control Group

Arm Description

This group receives a training in which intervals of intense work and periods of active rest are combined using a cycle ergometer with an intensity of 85-95% of the maximum heart rate [MHR], followed by intervals of active rest of 3 minutes duration. at 50-70% MCF.

The participants will perform a training on the cycle ergometer with an intensity close to 70% FCM maintained for 40 minutes and will be controlled individually.

The participants will receive advice on the general positive effects of the regular practice of physical activity, and will be given the guide of recommendations for the promotion of physical activity.

Outcomes

Primary Outcome Measures

Handgrip Strength
Dynamometer will be employed to assess handgrip Strength
Relative abundance
Determination of the % of specific bacteria in each of the taxonomic levels (phylum, family, genus and species).
Biodiversity
Alpha and beta diversity, have a great effect on our health, since greater microbiota diversity is related with health.
ABC-16 (Activities Specific Balance Confidence Scale)
Questionnaire that assesses balance confidence in performing activities of daily living. It is calculated by adding up the 16 responses of the questionnaire, with 0 being the minimum score and 100 being the maximum score. The higher value represents a better result.
FES-I (Falls Efficacy Scale-International)
Questionnaire that evaluates the fear of falling. The score ranges from 7 to 28 points. Higher values indicate more concern related to falls.
PSQI (Pittsburgh Sleep Quality Index)
A simple and valid evaluation of both the quality of sleep and the alterations that may affect it. It consists of a total of 19 questions, grouped into 10 questions. The 19 questions are combined to form seven domains (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep discomfort, medication use, and daytime dysfunction, adding up to a total score) with their corresponding score, each one of which shows a range between 0 and 3 points. The higher value represents a worse result. The higher value represents a worse result. Higher bases indicate poorer sleep.
HADS (The Hospital Anxiety And Depression)
A reliable, valid and practical screening tool for identifying and quantifying anxiety and/or depression in non-patients. The test contains 14 items with a score from 0 to 3, of which 7 items refer to depression and 7 to anxiety. The total score is 0-21, where a higher score corresponds to worse symptoms of anxiety and depression.
Percent of Body Fat (%)
Indicates the percentage of body fat to body weight.

Secondary Outcome Measures

BMI (Body Mass Index)
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat.
TUG (Timed Up and Go test)
Is a simple test used to assess a person's mobility and physical function.
Short Physical Performance Battery (SPPB)
It is an instrument that evaluates three aspects of mobility: balance, gait speed and strength of the lower limbs or limbs to get up from a chair.
Stabilometric Platform
instrument composed of resistive pressure sensors, used to measure the static or postural balance. The test was performed under both eyes-open and eyes-closed conditions.
FSS (Fatigue Severity Scale)
A self-report scale describing the severity of fatigue and the impact of fatigue on activities of daily living. The test is made up of 9 items with 7 response possibilities, so that 1 and 7 correspond to the minimum and maximum severity respectively. The total score corresponds to the sum of all the items with a total score range that goes from 9 to 63.
SF-36 (The Short Form-36 Health Survey)
Used extensively for assessing health-related quality of life. The test consists of 36 items that detect both positive and negative health states. The total score ranges from 0 to 100, where 0 represents the worst quality of life and 100 the best.
Percent of Body Fat (%)
Indicates the percentage of body fat to body weight.

Full Information

First Posted
December 16, 2021
Last Updated
April 25, 2022
Sponsor
University of Jaén
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1. Study Identification

Unique Protocol Identification Number
NCT05220670
Brief Title
Sarcopenia, Active Aging and Oral Microbiota. Effects of HIIT in Older Adults
Official Title
Sarcopenia, Active Aging and Oral Microbiota in Older Adults. Effects of a High Intensity Exercises Program by Intervals
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
January 10, 2022 (Actual)
Study Completion Date
April 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To analyze the effects of a high intensity exercises program by intervals on sarcopenia, active aging and oral microbiota in older adults.
Detailed Description
All participants will be advised to lead healthy lifestyle habits according to the recommendations of the "Plan for the Promotion of Physical Activity and Balanced Eating of the Junta de Andalucía" http://www.juntadeandalucia.es/educacion/webporta/ishareservlet/content/86cf9950-abaa-403b-9fc3 9bc5ecae4614. A submaximal stress test will be performed at the beginning and end of the intervention. Before the test, the participants will become familiar with the measuring instrument with a warm-up that allowed them a gain in understanding the gear system. The test will start with a pedaling cadence of 50 revolutions, with an output power of 0 W, increasing by 25 W every 2 minute period. During the test there will be a continuous recording of blood pressure, heart rate and maximum oxygen consumption (VO2max). With this stress test, the aerobic and anaerobic threshold of each participant will be determined to mark the intensity of work at which each subject must perform physical activity in the intervention period. The interventions of the 2 experimental groups are carried out with a frequency of 3 weekly trainings, for a total period of 16 weeks. The intensity of the training will be assigned to each subject individually based on the stress test performed in the previous phase. Experimental group 1 (HIIT): The HIIT protocol will be carried out after a 10-minute warm-up period with joint mobility exercises and dynamic stretching. The intervention will consist of training in which intense work intervals and active rest periods are combined using a cycle ergometer. The session will be divided into 4 intervals of 4 minutes duration at an intensity of 85-95% of the maximum heart rate [HRM], individually controlled during all sessions (Polar Team pro®), followed by active rest intervals 3 minute duration at 50-70% FCM. After the training, there will be a 10-minute cool down of gentle pedaling and joint range exercises. Experimental group 2 (MICT): Heating phase identical to the previous one. Subsequently, the participants will perform a training on the cycle ergometer with an intensity close to 70% FCM maintained for 40 minutes and will be controlled individually (Polar Team pro®). The session will conclude with a cool down phase identical to the previous one. Control group (CTRL): The participants will receive general advice on the positive effects of the regular practice of physical activity, and they will be given the guide of recommendations for the promotion of physical activity published by the Junta de Andalucía: http: // www.juntadeandalucia.es/salud/servicios/contenidos/andaluciaessalud/docs/130/Guia_Recomendaciones_AF.pdf

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
The assignment to the groups will be of simple random type and hidden. Those responsible for admitting patients to the intervention phase will not know what group has been assigned each. This assignment will be made in advance by a researcher who will not intervene in the later stages of evaluation, intervention, data recording and elaboration of database. The assignment will be communicated through sealed and totally opaque envelopes.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIIT Group
Arm Type
Experimental
Arm Description
This group receives a training in which intervals of intense work and periods of active rest are combined using a cycle ergometer with an intensity of 85-95% of the maximum heart rate [MHR], followed by intervals of active rest of 3 minutes duration. at 50-70% MCF.
Arm Title
MICT Group
Arm Type
Experimental
Arm Description
The participants will perform a training on the cycle ergometer with an intensity close to 70% FCM maintained for 40 minutes and will be controlled individually.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The participants will receive advice on the general positive effects of the regular practice of physical activity, and will be given the guide of recommendations for the promotion of physical activity.
Intervention Type
Other
Intervention Name(s)
HIIT
Intervention Description
It will be carried out after a 10-minute warm-up period with joint mobility exercises and dynamic stretching. The intervention will consist of a training in which intense work intervals and active rest periods are combined using a cycle ergometer. The session will be divided into 4 intervals of 4 minutes duration at an intensity of 85-95% of the maximum heart rate [MHR], individually controlled during all sessions (Polar Team pro®), followed by active rest intervals of 3 minutes duration at 50-70% FCM. After training, a 10-minute cool-down of gentle pedaling and joint range exercises will be carried out.
Intervention Type
Other
Intervention Name(s)
MICT
Intervention Description
Heating phase identical to the previous one. Subsequently, the participants will perform training on the cycle ergometer with an intensity close to 70% FCM maintained for 40 minutes and will be individually controlled (Polar Team pro®). The session will conclude with a cool-down phase identical to the previous one.
Primary Outcome Measure Information:
Title
Handgrip Strength
Description
Dynamometer will be employed to assess handgrip Strength
Time Frame
Up to twelve weeks
Title
Relative abundance
Description
Determination of the % of specific bacteria in each of the taxonomic levels (phylum, family, genus and species).
Time Frame
Up to twelve weeks
Title
Biodiversity
Description
Alpha and beta diversity, have a great effect on our health, since greater microbiota diversity is related with health.
Time Frame
Up to twelve weeks
Title
ABC-16 (Activities Specific Balance Confidence Scale)
Description
Questionnaire that assesses balance confidence in performing activities of daily living. It is calculated by adding up the 16 responses of the questionnaire, with 0 being the minimum score and 100 being the maximum score. The higher value represents a better result.
Time Frame
Up to twelve weeks
Title
FES-I (Falls Efficacy Scale-International)
Description
Questionnaire that evaluates the fear of falling. The score ranges from 7 to 28 points. Higher values indicate more concern related to falls.
Time Frame
Up to twelve weeks
Title
PSQI (Pittsburgh Sleep Quality Index)
Description
A simple and valid evaluation of both the quality of sleep and the alterations that may affect it. It consists of a total of 19 questions, grouped into 10 questions. The 19 questions are combined to form seven domains (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep discomfort, medication use, and daytime dysfunction, adding up to a total score) with their corresponding score, each one of which shows a range between 0 and 3 points. The higher value represents a worse result. The higher value represents a worse result. Higher bases indicate poorer sleep.
Time Frame
Up to twelve weeks
Title
HADS (The Hospital Anxiety And Depression)
Description
A reliable, valid and practical screening tool for identifying and quantifying anxiety and/or depression in non-patients. The test contains 14 items with a score from 0 to 3, of which 7 items refer to depression and 7 to anxiety. The total score is 0-21, where a higher score corresponds to worse symptoms of anxiety and depression.
Time Frame
Up to twelve weeks
Title
Percent of Body Fat (%)
Description
Indicates the percentage of body fat to body weight.
Time Frame
Up to twelve weeks
Secondary Outcome Measure Information:
Title
BMI (Body Mass Index)
Description
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat.
Time Frame
Up to twelve weeks
Title
TUG (Timed Up and Go test)
Description
Is a simple test used to assess a person's mobility and physical function.
Time Frame
Up to twelve weeks
Title
Short Physical Performance Battery (SPPB)
Description
It is an instrument that evaluates three aspects of mobility: balance, gait speed and strength of the lower limbs or limbs to get up from a chair.
Time Frame
Up to twelve weeks
Title
Stabilometric Platform
Description
instrument composed of resistive pressure sensors, used to measure the static or postural balance. The test was performed under both eyes-open and eyes-closed conditions.
Time Frame
Up to twelve weeks
Title
FSS (Fatigue Severity Scale)
Description
A self-report scale describing the severity of fatigue and the impact of fatigue on activities of daily living. The test is made up of 9 items with 7 response possibilities, so that 1 and 7 correspond to the minimum and maximum severity respectively. The total score corresponds to the sum of all the items with a total score range that goes from 9 to 63.
Time Frame
Up to twelve weeks
Title
SF-36 (The Short Form-36 Health Survey)
Description
Used extensively for assessing health-related quality of life. The test consists of 36 items that detect both positive and negative health states. The total score ranges from 0 to 100, where 0 represents the worst quality of life and 100 the best.
Time Frame
Up to twelve weeks
Title
Percent of Body Fat (%)
Description
Indicates the percentage of body fat to body weight.
Time Frame
Up to twelve weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 65 years SARC-F ≥4 or handgrip strength <16 kg for women and < 27 kg for men. Not being afflicted by any condition preventing physical activity. Not being engaged in regular physical activity >20 minutes and >3 days/week. Being able to communicate without difficulty. Being able to read and understand the informed consent form as well as the goals of the study. Exclusion Criteria: Acute or terminal illness. Unstable cardiovascular conditions. Conditions or medical treatments affecting the normal production of saliva (i.e. autoimmune disorders such as Sjögren's syndrome or medications like anxiolytics or antidepressants). Being or having been medicated with antibiotics up to one month prior to the taking of samples. Alcohol abuse or regular drug abuse. Severe visual or auditory impairment. Being involved in a different research group with the potential to interfere in our results.
Facility Information:
Facility Name
Andina Area University Foundation
City
Pereira
State/Province
Colombia
Country
Spain

12. IPD Sharing Statement

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Sarcopenia, Active Aging and Oral Microbiota. Effects of HIIT in Older Adults

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