Aging, Cardiovascular Health Status, Immunology, Nutritional Interventions, Physical Training, Respiratory Health
Conditions
Keywords
Elderly, resistance training, metabolism, hemodynamic processes, body composition
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.
Interventions
DIETARY_SUPPLEMENTWhey protein supplementation.
Protein supplementation will be provided through isolated whey protein, commonly known as whey protein isolate, which was generously donated by the Heroes Science Institute (HSI), as stated in the attached declaration. This whey protein isolate, with a vanilla flavor, is packaged in 25-gram sachets, each providing a total of 20 grams of protein per dose/sachet.
BEHAVIORALResistance training
The resistance training protocol in the study included seven exercises: high pull, leg extension, leg curl, bicep curl, triceps pushdown, lateral raise, and machine bench press, taking about 60 minutes per session. The first week focused on familiarizing participants with the exercises to ensure proper execution before intensive training began. Training occurred three times a week for 12 weeks, with each exercise performed in 3 sets of 8 to 12 repetitions and rest periods of 1 to 2 minutes. The load was progressively increased by 2% to 10% weekly, based on participants' ability to complete repetitions with full range of motion. Assessments were conducted before training and 24 hours after the final session to evaluate the effects on physical and functional parameters.
OTHERGroup Control
The control group will not participate in any of the interventions proposed in the study, meaning it will not receive supplementation or undergo resistance training, serving as a reference to compare the results of the other intervention groups.
Sponsors
Fundação de Amparo a Pesquisa do Estado de Goias (FAPEG)
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Brazil
Outcome results
None listed