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

NCT05481346 | Unknown DMC

• 1 other identifier: UALBIO2022/011
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia; Memory Loss; Muscular Atrophy; Cardiovascular Diseases; Frailty

Keywords

older adults; Healthy aging; Resistance training; cognitive training; cardiovascular training

Outcome Measures

Primary Outcomes (5)

• Body Weight in Kilograms

  was measured after removal of shoes and heavy outer clothing, using a Tanita BC-418 MA or InBody equipment to the nearest 0.1 kg.

  Change from Baseline body weight (kg) at 18 weeks

• Height in Meters

  Standing height without shoes was measured using a Seca 202 stadiometer (Seca, Hamburg, Germany) to the nearest 0.1 cm.

  Change from Baseline standing height (cm) at 18 weeks

• Body Mass Index (BMI)

  was calculated as the ratio of weight to squared height in kg/m\^2

  Change from Baseline Body Mass Index (BMI): (kg/m^2) at 18 weeks

• % Fat Mass

  % fat mass was measured after removal of shoes and heavy outer clothing, using a Tanita BC-418 MA or InBody equipment to the nearest 0.1 kg.

  Change from Baseline bioelectrical impedance % fat mass at 18 weeks

• Muscle quality sarcopenia

  Sarcopenia will be assessed taking into account the reference values established for muscle quality. The muscle quality will be measure by hand grip strength test. This test will be performance with manual dynamometry (TKK 5401; Scientific Instruments Co., Ltd., Tokyo, Japan). Maximal isometric upper limb strength will be performance by maximal isometric strength. Upper strength will be register by kilogrammes. Higher value show high strength.

  Change from Baseline to 18 weeks

Secondary Outcomes (16)

• Change Blood pressure

  Change from Baseline to 18 weeks

• Change Chair stand test

  Change from Baseline to 18 weeks

• Change Upper and Lower strength

  Change from Baseline to 18 weeks

• Health-related quality

  Change from Baseline to 18 weeks

• Cardiorrespiratory 6 minutes walk test

  Change from Baseline to 18 weeks

Study Arms (2)

Multidomain training group

EXPERIMENTAL

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.

Procedure: Multidomain training

Control group

NO INTERVENTION

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

Interventions

Multidomain training 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.

Multidomain training group

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Perform high-intensity aerobic exercise on a consistent basis (\>180 min-week).
• Be performing some other regular and systematic strength training program during the intervention in the first half of 2022.
• Have a body mass index greater than 35.
• Have a diagnosis of ischemic heart disease.
• Have a diagnosis of severe aortic stenosis, uncontrolled arrhythmias, decompensated heart failure or acute myocarditis.
• Possess uncontrolled blood pressure (TAS \>180 and TAD \>110).
• Stroke.
• Severe peripheral arterial disease.
• 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.
• Other pathologies that contraindicate the practice of physical exercise, collected in the previous medical examination that all participants must undergo.

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

Pablo Jorge Marcos Pardo

Almería, Spain

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Memory Disorders; Muscular Atrophy; Cardiovascular Diseases; Frailty

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurobehavioral Manifestations; Pathologic Processes

Study Officials

• Pablo Jorge Marcos Pardo, PhD

  Universidad de Almeria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pablo Jorge Marcos Pardo, PhD

CONTACT

+34 950214791; pjmarcos@ual.es

Pablo Jorge Marcos Pardo, PhD

CONTACT

+34 950214791; pablomarcospardo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: July 28, 2022
• Primary Completion: September 18, 2022
• Study Completion: December 30, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)