Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06682221

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Aging Cardiovascular Health Status Immunology Nutritional Interventions Physical Training Respiratory Health

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Evangelical University of Goiás - UniEVANGÉLICA

Anápolis, Goiás, 75.083-515, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whey protein supplementation.

Dietary Supplement

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.

Resistance training

Behavioral

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.

Group Control

Other

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.

Primary outcomes

  1. Lung function

    Time frame: 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).

  2. Pulmonary fibrotic biomarkers

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Research Support Foundation of the State of Goiás

Registry information

Official study title

EFFECTS of RESISTANCE TRAINING and PROTEIN SUPPLEMENTATION on CARDIORESPIRATORY, METABOLIC, IMMUNOLOGICAL, RENAL and BODY COMPOSITION VARIABLES in ELDERLY INDIVIDUALS

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.