Frail Elderly SyndromeNCT04376463
Effects of a Multicomponent Exercise and Supplementation of BCAA´s in Immunity System Dwelling Elderly
A study testing Branched Chain Aminoacid in people with Frail Elderly Syndrome and Physical Exercise, run by University of Coimbra at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly Syndrome, Physical Exercise
- What is being tested?
- Branched Chain Aminoacid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 13 Apr 2019to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Fried criteria
Who cannot join
- Dementia
- Morbid obesity, and the use of medications that may cause great attention impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Multicomponent Exercise and Supplementation of Branched Chain Aminoacids Health Parameters in the Dwelling Elderly
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
Read the 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
- Being tested
- Branched Chain Aminoacid
- Keywords
- Branched Chain Aminoacids Supplementation, Frail Elderly, Dwelling Elderly, Multicomponent Exercise, Immunology
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Branched Chain AminoacidDietary supplement
Also called Physical Exercise
It is an experimental design, controlled with 8 months of supplementation combined with exercise and washout 2 months, totalling 10 month intervention.
| Study group | Role | What they receive |
|---|---|---|
| Mood state and aminoacids supplementation | Experimental | 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. Receives: Dietary Supplement: Branched Chain Aminoacid |
| Physical Tests | Experimental | 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. Receives: Dietary Supplement: Branched Chain Aminoacid |
| Psychometrics evaluated | Experimental | Through the combination of bcaa supplementation and physical exercise, it is able to improve moods and cognition of the elderly. Receives: Dietary Supplement: Branched Chain Aminoacid |
| Fried Scale Phenotype | Experimental | 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). Receives: Dietary Supplement: Branched Chain Aminoacid |
What is being measured
The primary outcome is the main question the study is designed to answer.
THE INDEPENDENT AND COMBINED EFFECTS OF A 16-WEEK EXERCISE AND BCAA SUPPLEMENTATION ON FRAILTY MARKERS AND MOOD STATES OF OLDER WOMEN
Physical function and muscle strength Short physical performance battery (SPPB) was used to assess gait speed, chair stand, and balance tests. This SPPB test is composed of 3 subdimensions: i) static balance (composed of 3 tests), ii) muscular strength of the lower limb, which consist of get up and seat in a chair, 5 times, with arms crossed at the chest, and iii) 3-meter test, that marks the time to travels the 3-meter course, in the usual speed (Guralnik et al., 1994).
Measured: up to 24 weeks
Geriatric Depression Scale
The GDS-15, (Yesavage, 1982) consisting of 15 direct questions with yes or no answers, which evaluate e classify the psychological condition related to depression and its symptoms. The score result has 3 response modes 0 to 5 points indicates normal psychological condition, (no symptoms of depression), 6 to 10 points indicates (mild depressive symptoms), 11 to 15 indicates (symptoms of serious depression). The scale GDS was translate in Portuguese by (Apóstolo, 2014).
Measured: up to 24 weeks
Secondary outcomes (3)
Profile of Mood State short version (POMS-sv)
Profile of Mood State (McNair, 1971) is a test to evaluated individual's mood state. This tool, self-related and easy to use, is able to verify a transient profile. A short version (Raglin \& Morgan, 1989) was applied to facilitate use. POMS consist of 22 Likert-type question, divided in six dimensions with scales from 0 to 4. The final score consists of a sum of all negative dimensions subtracting the positive dimension of Vigour. Total Mood Disturbance (TMD) scores of Profile of Mood States (T+D+H+F+C)-V), (Tension-anxiety, depression-melancholia, Hostility-anger, Fatigue-inertia, Confusion, and Vigour), (Viana, Almeida, \& Santos, 2001).
Measured: through study completion, an average of 1 year
Mini Nutritional Assessment
Mini Nutritional Assessment The Mini Nutritional Assessment is calculated with a maximum total score of 30 points, in which the result of 17 points and below is characterized as malnourished, between 17 to 23.5 points, indicates a risk of malnutrition, and a score above 23.5 is normal nutritional status. A normal nutritional status was used to evaluate the nutritional status and the participants were classified as: Total points in the MNA® evaluation section (maximum 16 points). The results found will be sent to a nutritionist, (Loureiro, 2008). All participants were provided with similar diets, in terms of caloric intake and nutrients, controlled by a local nutritionist during the intervention period.
Measured: through study completion, an average of 1 year questionnaire of nutrition
The Charlson Comorbidity Index
The Charlson comorbidity index was used to classify comorbid conditions based on the registry of each individual comorbidity and was combined with age and gender to form a single index (Charlson et al., 1987).
Measured: through study completion, an average of 1 year (questionnaire) physiological parameter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start13 Apr 2019
- Primary completion14 Sep 2019
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adriana Caldo, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376463
- Sponsor's protocol ID
- UC
- Status last verified
- May 2020
- First submitted
- 13 Apr 2020
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a controlled longitudinal study experimental design, with 8 months of supplementation combined with exercise and washout 2 months, totalling 10 months intervention. Participants will receive a code number according to the order of recruitment. 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. The collection of data for the different variables will be 1-baseline, 2-post intervention (after 4 months of intervention), 3-washout period (after 2 months "detraining"), 4-final period (after 4 months intervention).
Publications
Rodrigues RN, Furtado G, Carballeira E, Sanchez-Sanchez JL, Herrero AC, Silva FM, Abreu C, Teixeira AM. Protective effects of elastic band training-detraining on Fall risk, power, body composition, and cognition in older adults with mild cognitive impairment: A 40-week trial. J Bodyw Mov Ther. 2025 Jun;42:23-33. doi: 10.1016/j.jbmt.2024.11.022. Epub 2024 Nov 23.
PubMed 40325674
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multicomponent Exercise and Supplementation of Branched Chain Aminoacids Health Parameters in the Dwelling Elderly
- ClinicalTrials.gov ID
- NCT04376463
- Acronym / sponsor ID
- UC
- Conditions
- Frail Elderly Syndrome, Physical Exercise
- Keywords
- Branched Chain Aminoacids Supplementation, Frail Elderly, Dwelling Elderly, Multicomponent Exercise, Immunology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- 13 Apr 2019 (actual)
- Primary completion
- 14 Sep 2019 (actual)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mood state and aminoacids supplementation | Experimental | Dietary Supplement: Branched Chain AminoacidThe 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. |
| Physical Tests | Experimental | Dietary Supplement: Branched Chain AminoacidThrough 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. |
| Psychometrics evaluated | Experimental | Dietary Supplement: Branched Chain AminoacidThrough the combination of bcaa supplementation and physical exercise, it is able to improve moods and cognition of the elderly. |
| Fried Scale Phenotype | Experimental | Dietary Supplement: Branched Chain AminoacidPrimary 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). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Fried criteria
Key exclusion criteria (2 listed)
- Dementia
- Morbid obesity, and the use of medications that may cause great attention impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Branched Chain AminoacidAlso: Physical ExerciseIt is an experimental design, controlled with 8 months of supplementation combined with exercise and washout 2 months, totalling 10 month intervention. | Dietary supplement | Fried Scale Phenotype, Mood state and aminoacids supplementation, Physical Tests, Psychometrics evaluated |
Primary outcome
THE INDEPENDENT AND COMBINED EFFECTS OF A 16-WEEK EXERCISE AND BCAA SUPPLEMENTATION ON FRAILTY MARKERS AND MOOD STATES OF OLDER WOMEN
Time frame: up to 24 weeks
Physical function and muscle strength Short physical performance battery (SPPB) was used to assess gait speed, chair stand, and balance tests. This SPPB test is composed of 3 subdimensions: i) static balance (composed of 3 tests), ii) muscular strength of the lower limb, which consist of get up and seat in a chair, 5 times, with arms crossed at the chest, and iii) 3-meter test, that marks the time to travels the 3-meter course, in the usual speed (Guralnik et al., 1994).
Geriatric Depression Scale
Time frame: up to 24 weeks
The GDS-15, (Yesavage, 1982) consisting of 15 direct questions with yes or no answers, which evaluate e classify the psychological condition related to depression and its symptoms. The score result has 3 response modes 0 to 5 points indicates normal psychological condition, (no symptoms of depression), 6 to 10 points indicates (mild depressive symptoms), 11 to 15 indicates (symptoms of serious depression). The scale GDS was translate in Portuguese by (Apóstolo, 2014).
3 secondary outcomes
Profile of Mood State short version (POMS-sv)
Time frame: through study completion, an average of 1 year
Mini Nutritional Assessment
Time frame: through study completion, an average of 1 year questionnaire of nutrition
The Charlson Comorbidity Index
Time frame: through study completion, an average of 1 year (questionnaire) physiological parameter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Derived from this study: PubMed 40325674Rodrigues RN, Furtado G, Carballeira E, Sanchez-Sanchez JL, Herrero AC, Silva FM, Abreu C, Teixeira AM. Protective effects of elastic band training-detraining on Fall risk, power, body composition, and cognition in older adults with mild cognitive impairment: A 40-week trial. J Bodyw Mov Ther. 2025 Jun;42:23-33. doi: 10.1016/j.jbmt.2024.11.022. Epub 2024 Nov 23.
- Individual participant dataSharing planned: No. This is a controlled longitudinal study experimental design, with 8 months of supplementation combined with exercise and washout 2 months, totalling 10 months intervention. Participants will receive a code number according to the order of recruitment. 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. The collection of data for the different variables will be 1-baseline, 2-post intervention (after 4 months of intervention), 3-washout period (after 2 months "detraining"), 4-final period (after 4 months intervention).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Branched Chain Aminoacid in people with Frail Elderly Syndrome and Physical Exercise, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
THE INDEPENDENT AND COMBINED EFFECTS OF A 16-WEEK EXERCISE AND BCAA SUPPLEMENTATION ON FRAILTY MARKERS AND MOOD STATES OF OLDER WOMEN (time frame: up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04376463, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.