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

NCT06682221 | Enrolling By Invitation Phase 3

• 2 other identifiers: 6.095.284202310267000648
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Cardiovascular Health Status; Physical Training; Nutritional Interventions; Respiratory Health; Immunology

Keywords

Elderly; resistance training; metabolism; hemodynamic processes; body composition

Outcome Measures

Primary Outcomes (2)

• Lung function

  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).

  Three months

• Pulmonary fibrotic biomarkers

  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).

  Three months

Study Arms (4)

Whey protein supplementation.

EXPERIMENTAL

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.

Dietary Supplement: Whey protein supplementation.

Resistance training

EXPERIMENTAL

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.

Behavioral: Resistance training

Whey protein supplementation and Resistance training

SHAM COMPARATOR

The participants would simultaneously apply both protocols, involving both supplementation and resistance training, to assess the combined effects of these interventions on their health and physical conditioning.

Dietary Supplement: Whey protein supplementation.; Behavioral: Resistance training

Control

SHAM COMPARATOR

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.

Other: Group Control

Interventions

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.

Whey protein supplementation and Resistance training; Whey protein supplementation.

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.

Resistance training; Whey protein supplementation and Resistance training

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.

Control

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Fundação de Amparo a Pesquisa do Estado de Goias (FAPEG): collaborator

Study Sites (1)

Evangelical University of Goiás - UniEVANGÉLICA

Anápolis, Goiás, 75.083-515, Brazil

Location

MeSH Terms

Interventions

Resistance Training; Control Groups

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BSc., MSc., PhD.

Model Details: 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).

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: February 16, 2024
• Primary Completion: December 16, 2024
• Study Completion: December 9, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Beginning: 11 December 2024. End: 31 January 2025.
• Access Criteria: The principal investigator will have access to IPS and all data through data bank used in the Laboratory of Pulmonary and Exercise Immunology.

Locations

BR (1)