Clinical trial NCT05481346: Effects of Multidomain Training of Health With Aging (Train-Old)
Official title: Psycho-physiological Effects of Multidomain Training in Adults and Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Memory Loss
Muscular Atrophy
Cardiovascular Diseases
Frailty
Keywords: older adults
Healthy aging
Resistance training
cognitive training
cardiovascular training
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Body Weight in Kilograms
timeFrame: Change from Baseline body weight (kg) at 18 weeks
measure: Height in Meters
timeFrame: Change from Baseline standing height (cm) at 18 weeks
measure: Body Mass Index (BMI)
timeFrame: Change from Baseline Body Mass Index (BMI): (kg/m^2) at 18 weeks
measure: % Fat Mass
timeFrame: Change from Baseline bioelectrical impedance % fat mass at 18 weeks
measure: Muscle quality sarcopenia
timeFrame: Change from Baseline to 18 weeks
Secondary outcomes:
measure: Change Blood pressure
timeFrame: Change from Baseline to 18 weeks
measure: Change Chair stand test
timeFrame: Change from Baseline to 18 weeks
measure: Change Upper and Lower strength
timeFrame: Change from Baseline to 18 weeks
measure: Health-related quality
timeFrame: Change from Baseline to 18 weeks
measure: Cardiorrespiratory 6 minutes walk test
timeFrame: Change from Baseline to 18 weeks
measure: Change heart rate
timeFrame: Change from Baseline to 18 weeks
measure: Gait speed
timeFrame: Change from Baseline to 18 weeks
measure: Time up and go test change
timeFrame: Change from Baseline to 18 weeks
measure: Short physical performance battery (SPPB)
timeFrame: Change from Baseline to 18 weeks
measure: Fragility
timeFrame: Change from Baseline to 18 weeks
measure: Satisfaction with life
timeFrame: Change from Baseline to 18 weeks
measure: Depression
timeFrame: Change from Baseline to 18 weeks
measure: Cognitive flexibility
timeFrame: Change from Baseline to 18 weeks
measure: Attention test
timeFrame: Change from Baseline to 18 weeks
measure: PSQ test
timeFrame: Change from Baseline to 18 weeks
measure: TMMS-24
timeFrame: Change from Baseline to 18 weeks
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Pablo Jorge Marcos Pardo
Study officials:
affiliation: Universidad de Almeria
name: Pablo Jorge Marcos Pardo, PhD
role: PRINCIPAL_INVESTIGATOR
References: