Clinical trial NCT04376463: Effects of a Multicomponent Exercise and Supplementation of BCAA´s in Immunity System Dwelling Elderly
Official title: Effects of a Multicomponent Exercise and Supplementation of Branched Chain Aminoacids Health Parameters in the Dwelling Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frail Elderly Syndrome
Physical Exercise
Keywords: Branched Chain Aminoacids Supplementation
Frail Elderly
Dwelling Elderly
Multicomponent Exercise
Immunology
Lead sponsor: University of Coimbra
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It was an experimental design, controlled, non-randomized, with a convenience sample of 16-week supplementation combined or not with exercise. All participants in the groups ME+BCAA and BCAA received at the beginning of the protocol a bottle with assigned codes with flavourless powder (BCAA), and a dosage of 0.21g/kg/session. They took the supplement with 200 ml of water immediate after exercise, in the ME+BCAA group, and at the same time in the BCAA group (Ispoglou et al., 2016). Throughout the intervention period, all tests and intervention were done after breakfast and before lunch (supplementation, physical exercise, data collection, questionnaires, physical tests), and 30-60 minutes before lunch. The ME group just folowed the exercice protocol, and CGne group did not alter their usual routine.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* Fried criteria

Exclusion Criteria:

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

Primary outcomes:
measure: THE INDEPENDENT AND COMBINED EFFECTS OF A 16-WEEK EXERCISE AND BCAA SUPPLEMENTATION ON FRAILTY MARKERS AND MOOD STATES OF OLDER WOMEN
timeFrame: up to 24 weeks
measure: Geriatric Depression Scale
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Profile of Mood State short version (POMS-sv)
timeFrame: through study completion, an average of 1 year
measure: Mini Nutritional Assessment
timeFrame: through study completion, an average of 1 year questionnaire of nutrition
measure: The Charlson Comorbidity Index
timeFrame: through study completion, an average of 1 year (questionnaire) physiological parameter
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Adriana Caldo
Study officials:
References: