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

Cardiovascular Diseases Clinical Trial

— Train-Old  

Official title:

Psycho-physiological Effects of Multidomain Training in Adults and Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05481346
• Other study ID #: UALBIO2022/011
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2022
• Source: Universidad de Almeria
• Contact: Pablo Jorge Marcos Pardo, PhD
• Phone: +34 950214791
• Email: pjmarcos[@]ual.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 30, 2022
• Est. primary completion date: September 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Frailty
• Memory Disorders
• Memory Loss
• Muscular Atrophy
• Sarcopenia

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Spain	Pablo Jorge Marcos Pardo	Almería

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Almeria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	% 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
Primary	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	Change Blood pressure	Blood pressure and heart rate will be assessed by means of an automatic device (Colin BP 880, Inc., Tampa, FL). This is noninvasive technique. The result will be register in millimeters of mercury (bood pressure) and number of pulse per minutes (heart rate).	Change from Baseline to 18 weeks
Secondary	Change Chair stand test	Chair stand test measure the functional capacity. This is a easy physical test. This test measures the functionality of getting up and sitting down from a chair five times. The participant have to performance the test as faster as possible. The total time is recorded in seconds. A better time indicates better functional ability.	Change from Baseline to 18 weeks
Secondary	Change Upper and Lower strength	Maximal isometric upper limb strength will be performance by maximal isometric strength of knee extension and biceps flexion with load cell. Maximal isometric lower limb will be registered in newton. Higher value show high strength.	Change from Baseline to 18 weeks
Secondary	Health-related quality	SF-36 quality of life questionnaire	Change from Baseline to 18 weeks
Secondary	Cardiorrespiratory 6 minutes walk test	cardiorespiratory endurance test that evaluates the distance covered in 6 minutes.	Change from Baseline to 18 weeks
Secondary	Change heart rate	Heart rate will be assessed by means of an automatic device (Colin BP 880, Inc., Tampa, FL). This is noninvasive technique. The result will be register in number of pulse per minutes (heart rate).	Change from Baseline to 18 weeks
Secondary	Gait speed	Gait speed will be measure by 4. 6 and 10 meter test. This is easy physical test in with the participant have to walk 4. 6 and 10 metres as faster as possible. The result will be register in seconds. Less time indicates better functional ability.	Change from Baseline to 18 weeks
Secondary	Time up and go test change	Time up and go test measure the functional capacity of getting up, walking and sitting down form a chair. Participant have to performance this test as faster as possible. This is a easy physical test. Total seconds are records. Less seconds indicates better functional ability.	Change from Baseline to 18 weeks
Secondary	Short physical performance battery (SPPB)	Short physical performance battery (SPBB) include three test (balance, chair stand test and gait speed) and report a final score. Chair stand test and gait speed were describe in other outcome. Balance test is a easy physical test. The participant must maintain three balancing positions for 10 seconds to overcome it. Each test offers a different score. Higher score show better functional capacity.	Change from Baseline to 18 weeks
Secondary	Fragility	Frailty will be defined in relation to Fried's frailty phenotype (Fried et al., 2001), based on 5 criteria: unintentional weight loss, exhaustion, weakness, slow walking speed and low physical activity.	Change from Baseline to 18 weeks
Secondary	Satisfaction with life	The Satisfaction with Life Scale is a 4-item instrument with a Likert-type scale ranging from 1 to 7 points measuring overall subjective happiness by means of statements in which participants rate themselves or compare themselves with others. Two items ask people to describe themselves using absolute rating criteria of their lives or rating criteria with respect to others, while the other two items present brief descriptions of happy or unhappy people and respondents are asked to indicate the degree to which they identify with that description.	Change from Baseline to 18 weeks
Secondary	Depression	Depression will be measured through the Center for Epidemiological Studies Depression Scale-Revised (CESD-R) (Van Dam & Earleywine, 2011), is a 20-item questionnaire that can be used to measure levels of depressive symptoms among elderly participants. The CESD-R consists of 16 items of negative affect and 4 items of positive affect.	Change from Baseline to 18 weeks
Secondary	Cognitive flexibility	the Stroop test measures the ability to classify information selectively. It consists of 3 phases and requires discerning between colors and words without making mistakes.	Change from Baseline to 18 weeks
Secondary	Attention test	the Trail Making test will also assess flexibility of thought and visuospatial ability. It consists of joining numbers and words in a numerical sequence without error.	Change from Baseline to 18 weeks
Secondary	PSQ test	To evaluate the factors that influence the general state of health, specifically stress. It evaluates six factors: Tension-Instability-Fatigue; Social Acceptance of Conflict; Energy and Fun; Overload; Satisfaction for self-fulfillment; Fear and anxiety.	Change from Baseline to 18 weeks
Secondary	TMMS-24	Trait-Meta Mood Scale (TMMS) emotional states	Change from Baseline to 18 weeks