Effects of Multidomain Training of Health With Aging (Train-Old)

NCT ID: NCT05481346

Last Updated: 2022-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-28

Study Completion Date

2022-12-30

Brief Summary

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The current study aims to determine the effect of a multidomain intervention (physical fitness, motivational and cognitive training) on body composition, sarcopenia, cardiovascular health, physical fitness, functional capacity, quality of life, frailty, emotional state and cognitive status in elderly participants, through a randomized controlled trial, to determine its suitability and recommend it as a preventive and health strategy for community-dwelling older adults.

Detailed Description

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Conditions

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Sarcopenia Memory Loss Muscular Atrophy Cardiovascular Diseases Frailty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to an experimental group that will perform the physical exercise program and a control group that will perform nothing and continue with their normal lifestyle routines, without any physical activity.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Multidomain training group

Participants will use free weights and functional materials to work the main muscle groups. In addition, they will perform cardiorespiratory training and cognitive training with proposed tasks. Participants will follow the planned training progression. The researchers will record the number of sets completed and the load lifted for each exercise for each participant and the perception of effort in each class.

Group Type EXPERIMENTAL

Multidomain training

Intervention Type PROCEDURE

The training program has a duration of 18 weeks with 2 training sessions per week. The training will have a gradual progression of intensity. One day they train two blocks of strength and one block of cognitive exercises and on the second day, they train one block of power, one block of strength+cognitive and one block of aerobic training.

All sessions are 60 minutes long (10 minutes of warm-up, 40 minutes of training and 10 minutes of cool-down). Classes are in small groups of no more than 8 members.

Control group

The control group did not receive a training program and were asked not to modify their physical activity habits.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Multidomain training

The training program has a duration of 18 weeks with 2 training sessions per week. The training will have a gradual progression of intensity. One day they train two blocks of strength and one block of cognitive exercises and on the second day, they train one block of power, one block of strength+cognitive and one block of aerobic training.

All sessions are 60 minutes long (10 minutes of warm-up, 40 minutes of training and 10 minutes of cool-down). Classes are in small groups of no more than 8 members.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Subject has provided written and dated informed consent to participate in the study.
2. Subject is a male or female between 55 and 90 years of age, inclusive.
3. Subject is in good health as determined by a health history questionnaire and has been provided clearance from their personal physician.
4. Subject is untrained in resistance and aerobic exercise (does not participate in structured physical activity, including walking, more than 3 times per week).
5. Ability to walk independently without any gait aid

Exclusion Criteria

1. Perform high-intensity aerobic exercise on a consistent basis (\>180 min-week).
2. Be performing some other regular and systematic strength training program during the intervention in the first half of 2022.
3. Have a body mass index greater than 35.
4. Have a diagnosis of ischemic heart disease.
5. Have a diagnosis of severe aortic stenosis, uncontrolled arrhythmias, decompensated heart failure or acute myocarditis.
6. Possess uncontrolled blood pressure (TAS \>180 and TAD \>110).
7. Stroke.
8. Severe peripheral arterial disease.
9. Other illnesses such as recent thromboembolic disease, aortic aneurysm, clinically significant renal or hepatic insufficiency, severe COPD, clinically significant acute infections, severe psychiatric illness, uncontrolled metabolic disease, limiting locomotor pathology or musculoskeletal disease worsened by exercise, hormone therapy at the time or one year prior, being a woman with surgical menopause.
10. Other pathologies that contraindicate the practice of physical exercise, collected in the previous medical examination that all participants must undergo.
Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Almeria

OTHER

Sponsor Role lead

Responsible Party

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Pablo Jorge Marcos Pardo

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pablo Jorge Marcos Pardo, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Almeria

Locations

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Pablo Jorge Marcos Pardo

Almería, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Pablo Jorge Marcos Pardo, PhD

Role: CONTACT

+34 950214791

Pablo Jorge Marcos Pardo, PhD

Role: CONTACT

+34 950214791

Facility Contacts

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Pablo Jorge Marcos Pardo, PhD

Role: primary

Antonio Jesús Casimiro Andújar, PhD

Role: backup

Other Identifiers

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UALBIO2022/011

Identifier Type: -

Identifier Source: org_study_id

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