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

Sarcopenia Clinical Trial

Official title:

Sarcopenia, Active Aging and Oral Microbiota in Older Adults. Effects of a High Intensity Exercises Program by Intervals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05220670
• Other study ID #: University_Jaen
• Status: Completed
• Phase: N/A
• Start date: December 20, 2021
• Est. completion date: April 11, 2022

Study information

• Verified date: April 2022
• Source: University of Jaén
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To analyze the effects of a high intensity exercises program by intervals on sarcopenia, active aging and oral microbiota in older adults.

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-9f c3 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_Recomendaci ones_AF.pdf

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 11, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Other:
• HIIT
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.
• MICT
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.

Locations

Country	Name	City	State
Spain	Andina Area University Foundation	Pereira	Colombia

Sponsors (1)

Lead Sponsor	Collaborator
University of Jaén

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Handgrip Strength	Dynamometer will be employed to assess handgrip Strength	Up to twelve weeks
Primary	Relative abundance	Determination of the % of specific bacteria in each of the taxonomic levels (phylum, family, genus and species).	Up to twelve weeks
Primary	Biodiversity	Alpha and beta diversity, have a great effect on our health, since greater microbiota diversity is related with health.	Up to twelve weeks
Primary	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.	Up to twelve weeks
Primary	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.	Up to twelve weeks
Primary	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.	Up to twelve weeks
Primary	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.	Up to twelve weeks
Primary	Percent of Body Fat (%)	Indicates the percentage of body fat to body weight.	Up to twelve weeks
Secondary	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.	Up to twelve weeks
Secondary	TUG (Timed Up and Go test)	Is a simple test used to assess a person's mobility and physical function.	Up to twelve weeks
Secondary	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.	Up to twelve weeks
Secondary	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.	Up to twelve weeks
Secondary	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.	Up to twelve weeks
Secondary	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.	Up to twelve weeks
Secondary	Percent of Body Fat (%)	Indicates the percentage of body fat to body weight.	Up to twelve weeks