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NCT04376463
Effects of a Multicomponent Exercise and Supplementation of BCAA´s in Immunity System Dwelling Elderly
NA trial testing Branched Chain Aminoacid in Frail Elderly Syndrome in 50 participants. Status unknown.
14 September 2019
Quick facts
| Lead sponsor | University of Coimbra |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | health services research |
| Enrollment | 50 |
| Start date | 13 April 2019 |
| Primary completion | 14 September 2019 |
| Estimated completion | 15 December 2020 |
| Sites | 1 location across Portugal |
Drugs / interventions tested
- Branched Chain Aminoacid
Conditions studied
- Frail Elderly Syndrome — all drugs for Frail Elderly Syndrome →
- Physical Exercise — all drugs for Physical Exercise →
Sponsor
University of Coimbra
Who can join
65 and older, any sex, with Frail Elderly Syndrome or Physical Exercise. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Effect of Training-Detraining Phases of Multicomponent Exercises and BCAA Supplementation on Inflammatory Markers and Albumin Levels in Frail Older Persons.
Caldo-Silva A, Furtado GE, Chupel MU, Bachi ALL, et al · · 2021 · cited 21× · PMID 33800577 · DOI 10.3390/nu13041106 -
Empowering frail older adults: multicomponent elastic-band exercises and BCAA supplementation unleash physical health and preserve haematological biomarkers.
Caldo-Silva A, Furtado GE, Chupel MU, Letieri RV, et al · · 2023 · cited 12× · PMID 37720080 · DOI 10.3389/fspor.2023.1171220 -
The Effect of a Resistance Training, Detraining and Retraining Cycle on Postural Stability and Estimated Fall Risk in Institutionalized Older Persons: A 40-Week Intervention.
Rodrigues RN, Carballeira E, Silva F, Caldo-Silva A, et al · · 2022 · cited 5× · PMID 35627913 · DOI 10.3390/healthcare10050776
Verify or expand the search:
- PubMed search for NCT04376463
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Coimbra trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04376463 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Coimbra
- Last refreshed: 6 May 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04376463.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing