Clinical trial NCT06682221: Effects of Resistance Training and Supplementation in Elderly: Cardiorespiratory and Metabolic Variables
Official title: EFFECTS of RESISTANCE TRAINING and PROTEIN SUPPLEMENTATION on CARDIORESPIRATORY, METABOLIC, IMMUNOLOGICAL, RENAL and BODY COMPOSITION VARIABLES in ELDERLY INDIVIDUALS
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Aging
Cardiovascular Health Status
Physical Training
Nutritional Interventions
Respiratory Health
Immunology
Keywords: Elderly
resistance training
metabolism
hemodynamic processes
body composition
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: FundaÃ§Ã£o de Amparo a Pesquisa do Estado de Goias (FAPEG)
First posted: 2024-11-12
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The elderly participants will be between 60 and 85 years old and will be randomly assigned to one of four groups, with n = 40 in each group: Control Group (CG; untrained and unsupplemented; n = 40), Supplemented Group (SG; untrained and supplemented; n = 40), Trained Group (TG; trained and unsupplemented; n = 40), and Trained and Supplemented Group (TSG; trained and supplemented; n = 40).
Primary purpose: TREATMENT

Brief summary: Aging causes losses in strength, lean mass, and cardiovascular health in the elderly due to metabolic changes and alterations in body composition. To investigate whether nutritional interventions and physical training can mitigate these effects, a randomized clinical trial will be conducted at the Evangelical University of Goiás with elderly individuals aged 60 to 85. Participants will be divided into four groups: control, protein supplementation, physical training, and a combination of both. The study will last for 12 months, with evaluations every four months, covering cardiovascular, pulmonary, immunological, renal, muscular, and hematological parameters. The analyses will seek statistical significance, and it is expected that the interventions will significantly improve the participants\&#39; health.

Detailed description: The aging process is associated with declines in strength, lean mass (LM), and cardiovascular (CV) and cardiorespiratory (CR) health due to metabolic, hemodynamic, and body composition changes in the elderly. The implications of these changes can potentially be mitigated through nutritional intervention and physical training. To test this hypothesis, a randomized clinical trial will be conducted at the Evangelical University of Goiás (UniEVANGÉLICA), where elderly volunteers (aged 60 to 85) will be randomized (n = 40/group) into control groups (no protein supplementation and no physical training), supplementation group (only protein supplementation), training group (only physical training), and a combined group (physical training + protein supplementation). The supplementation and training protocols will be conducted for 12 months, with evaluations occurring before the protocol begins and every four months thereafter. Numerous cardiovascular, pulmonary, immunological, renal, muscular, and hematological parameters will be assessed. Analyses will be expressed as mean and standard deviation, with a significance level of p≤0.05 for paired t-tests and multiparametric analyses. It is expected that the effects of the resistance training and protein supplementation protocols, together or separately, will significantly improve the described parameters, yielding positive results for the participants.

Eligibility criteria: Inclusion Criteria:

- Individuals who volunteer to participate in the study must sign the Informed Consent Form (ICF), be willing to participate in all assessments, and maintain a minimum attendance of 75% in the classes.

Exclusion Criteria:

* Individuals with neurological diseases that prevent them from participating in the assessments and the physical training program will not be eligible.

Primary outcomes:
measure: Lung function
timeFrame: Three months
measure: Pulmonary fibrotic biomarkers
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Anapolis
country: Brazil
facility: Evangelical University of Goiás - UniEVANGÉLICA
state: GO
Study officials:
References: