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

NCT05220670 | Completed

• 1 other identifier: University_Jaen
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (8)

• Handgrip Strength

  Dynamometer will be employed to assess handgrip Strength

  Up to twelve weeks

• Relative abundance

  Determination of the % of specific bacteria in each of the taxonomic levels (phylum, family, genus and species).

  Up to twelve weeks

• Biodiversity

  Alpha and beta diversity, have a great effect on our health, since greater microbiota diversity is related with health.

  Up to twelve weeks

• 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

• 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

• 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

• 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

• Percent of Body Fat (%)

  Indicates the percentage of body fat to body weight.

  Up to twelve weeks

Secondary Outcomes (7)

• BMI (Body Mass Index)

  Up to twelve weeks

• TUG (Timed Up and Go test)

  Up to twelve weeks

• Short Physical Performance Battery (SPPB)

  Up to twelve weeks

• Stabilometric Platform

  Up to twelve weeks

• FSS (Fatigue Severity Scale)

  Up to twelve weeks

Study Arms (3)

HIIT Group

EXPERIMENTAL

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.

Other: HIIT

MICT Group

EXPERIMENTAL

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.

Other: MICT

Control Group

NO INTERVENTION

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.

Interventions

HIIT OTHER

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.

HIIT Group

MICT OTHER

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.

MICT Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

Andina Area University Foundation

Pereira, Colombia, Spain

Location

Related Publications (1)

• Lavilla-Lerma ML, Aibar-Almazan A, Martinez-Amat A, Jimenez-Garcia JD, Hita-Contreras F. Moderate-intensity continuous training and high-intensity interval training modulate the composition of the oral microbiota of elderly adults: Randomized controlled trial. Maturitas. 2024 Jul;185:107973. doi: 10.1016/j.maturitas.2024.107973. Epub 2024 Mar 26.

  PMID: 38579579 DERIVED

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: February 2, 2022
• Study Start: December 20, 2021
• Primary Completion: January 10, 2022
• Study Completion: April 11, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

ES (1)