Effects of Resistance Training and Supplementation in Elderly: Cardiorespiratory and Metabolic Variables

Phase 3

• Conditions: Aging; Cardiovascular Health Status; Physical Training; Nutritional Interventions; Respiratory Health; Immunology

• Registration Number: NCT06682221
• Lead Sponsor: Federal University of São Paulo

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\' 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.

Study Timeline

• Study Start: 2024-02-16
• Status Verified: 2024-09
• Study First Submitted: 2024-11-07
• Study First Submitted QC: 2024-11-07
• Last Update Submitted: 2024-11-07
• Study First Posted: 2024-11-11
• Last Update Posted: 2024-11-11
• Primary Completion: 2024-12-16
• Study Completion: 2025-12-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lung function	Three months	Pulmonary function will be assessed using a Master Screen spirometer (Jaeger, Germany), employing the forced maneuver in accordance with the standards set by the Brazilian Society of Pneumology and Tisiology. All participants will undergo spirometric testing before and after the administration of a rapid-acting bronchodilator (Salbutamol 400 mcg). The parameters to be evaluated will include Forced Vital Capacity (FVC), Forced Expiratory Volume in the first second (FEV1), the FEV1/FVC ratio, Peak Expiratory Flow (PEF), and Expiratory Flow between 25% and 75% of FVC (FEF25-75).
Pulmonary fibrotic biomarkers	Three months	The condensed air will be obtained through tidal breathing in a tube called RTube (Respiratory Research, USA), where the volunteer will breathe for a period of 15 minutes. After this period, the condensed air will be collected and stored at -86ºC for the analysis of cytokine levels, growth factors, and anti-fibrotic proteins, as already standardized in our laboratory (Moraes-Ferreira et al., 2022).

Trial Locations

Locations (1)

Evangelical University of Goiás - UniEVANGÉLICA; 🇧🇷 Anapolis, GO, Brazil