Effects of a Multicomponent Exercise and Supplementation of BCAA´s in Immunity System Dwelling Elderly

NCT ID: NCT04376463

Last Updated: 2020-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-13
• Study Completion Date: 2020-12-15

Brief Summary

The frailty syndrome (FS) is characterized by a multifactorial clinical syndrome, which includes 5 items, 1 - Change in body composition, 2 - Holding force, 3 - Fatigue reported, 4 - Reduction of walking speed, 5 - Low physical activity. The cumulative effect of deficits on the physiological functions caused by the syndrome results in early physical and cognitive loss. It is known that physical exercise, associated with protein supplementation are examples of non-pharmacological treatments that can promote functional and structural adaptive responses of the skeletal muscle system. One of the factors related to frailty is the reduction of body and muscle mass. Branched-chain amino acids, especially leucine, are nutrients that influence the adaptative response of muscle. It is intended through a physical exercise program (multicomponent = exercise of strength + aerobic exercise), to attenuate the effects of ageing and mainly of physical and cognitive frailty, evaluating the health parameters of frail elderly, alone or together with supplementation (BCAA), branched-chain amino acids, modulation of immune markers, markers of malnutrition and the skeletal muscle system in frail and pre-frail dwelling elderly people living in the city of Coimbra. To achieve that, the following parameters will be evaluated: biosocial indicators, anthropometric evaluation and body composition, indicators of global health and functional physical fitness, inflammatory biomarkers, neuroendocrine, signs of skeletal muscle function, evaluation of quality of life related to emotional state, cognitive profile and frailty-trait evaluation. The results obtained from the indicators, markers and questionnaires used are expected to contribute to the attenuation of frailty, improving the health and quality of life of the elderly.

Keywords: frail elderly, multicomponent exercise, branched chain amino acid, healthy life

Detailed Description

This investigation was conducted in accordance with the guidelines laid down in the Declaration of Helsinki. All procedures were approved by the University Faculty Research Ethics Committee and written informed consent was obtained from all participants. This PhD project is inserted in the thematic line of the (CIDAF) Research Centre in Physical Activity and Ageing; Ageing: Is It Ever Too Late to be Active and Healthy / Fit? This project will also be sent to the homes of all the participants in the study to sign a term so that they can sign a consent for the implementation of the study at their premises.

During the period of the intervention of the exercise and after the experimental period, an interview will be done through questionnaires, biosocial and overall health status. The main results will be the cognitive, biosocial and overall health status. There will be a session to administer a test battery on the overall health status, cognitive status (screening of cognition), and screening for mobility. Secondary measures include psychological well-being, cognition, anthropometric, immunological, and neurological parameters.

Experimental design (supplementation time)

It is an experimental design, controlled with 6 months of supplementation combined with exercise. Participants will receive a code number according to the order of recruitment. The participants sample was non-randomization, sample was convenience, will be performed using the assignment list and code number after recruitment for the study. Initially the elderly will be divided into 4 groups: Multicomponent Exercise + BCAA (ME+BCAA) group 1, Multicomponent Exercise (ME) group 2, BCAA group 3, Control non-exercise (CONTROL) group 4. Data collection was performed at 4 moments,1-Initial time (baseline), 2-After 16 weeks training period, 3-After 8 weeks detraining period and 4-After 16 weeks period, totaling 4 collections throughout the project and 40 weeks.

The supplement was supplied through the company and has about 95% purity and trade certification in the EU. The subjects ingested 1 sachet (0,21g/kg/session) prepared after to finish exercise by mixing the contents of each sachet with 200mL water and consuming as follows: first beverage during the morning after breakfast and before lunch.

Conditions

Frail Elderly Syndrome; Physical Exercise

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Mood state and aminoacids supplementation

The aim of this study was to analyse the isolated and combined effects of BCAA supplementation and exercise on physical frailty status and mood states in pre-frail institutionalized older women.

Group Type: EXPERIMENTAL

Branched Chain Aminoacid

Intervention Type: DIETARY_SUPPLEMENT

It is an experimental design, controlled with 8 months of supplementation combined with exercise and washout 2 months, totalling 10 month intervention.

Physical Tests

Through the combination of bcaa supplementation and physical exercise is able to improve the functional capacity of the elderly, through the SPPB test battery, short performance physical battery.

Group Type: EXPERIMENTAL

Branched Chain Aminoacid

Intervention Type: DIETARY_SUPPLEMENT

It is an experimental design, controlled with 8 months of supplementation combined with exercise and washout 2 months, totalling 10 month intervention.

Psychometrics evaluated

Through the combination of bcaa supplementation and physical exercise, it is able to improve moods and cognition of the elderly.

Group Type: EXPERIMENTAL

Branched Chain Aminoacid

Intervention Type: DIETARY_SUPPLEMENT

It is an experimental design, controlled with 8 months of supplementation combined with exercise and washout 2 months, totalling 10 month intervention.

Fried Scale Phenotype

Primary outcomes include Physical Frailty evaluated according to Fried's Frailty Phenotype2): Shrinking assessed by self-report of unintentional weight loss of four kilograms or more in the last six months; Self-reported exhaustion evaluated by concordance of two questions (7 and 20) of the Center for Epidemiology-Depression (CES-D) scale; Weakness analyzed using the handgrip strength test; Slowness measured by the 4.6 meters walking test; levels of Physical Activity assessed by the (IPAQ).

Group Type: EXPERIMENTAL

Branched Chain Aminoacid

Intervention Type: DIETARY_SUPPLEMENT

It is an experimental design, controlled with 8 months of supplementation combined with exercise and washout 2 months, totalling 10 month intervention.

Interventions

Branched Chain Aminoacid

It is an experimental design, controlled with 8 months of supplementation combined with exercise and washout 2 months, totalling 10 month intervention.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Physical Exercise

Eligibility Criteria

Inclusion Criteria

• Fried criteria

Exclusion Criteria

• Dementia
• Morbid obesity, and the use of medications that may cause great attention impairment.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Coimbra

OTHER

Sponsor Role: lead

Responsible Party

Adriana Caldo

Researcher, principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Adriana Caldo

Coimbra, , Portugal

Countries

Portugal

Other Identifiers

UC

Identifier Type: -

Identifier Source: org_study_id