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

NCT ID: NCT06682221

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-16
• Study Completion Date: 2025-12-09

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Whey 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.

Group Type: EXPERIMENTAL

Whey protein supplementation.

Intervention Type: 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

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 Type: EXPERIMENTAL

Resistance training

Intervention Type: 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.

Whey protein supplementation and Resistance training

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.

Group Type: SHAM_COMPARATOR

Whey protein supplementation.

Intervention Type: 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

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Group Control

Intervention Type: 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.

Interventions

Whey 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.

Intervention Type: DIETARY_SUPPLEMENT

Resistance 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.

Intervention Type: BEHAVIORAL

Group 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo a Pesquisa do Estado de Goias (FAPEG)

UNKNOWN

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Rodolfo de Paula Vieira

BSc., MSc., PhD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Evangelical University of Goiás - UniEVANGÉLICA

Anápolis, Goiás, Brazil

Countries

Brazil

Other Identifiers

202310267000648

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

6.095.284

Identifier Type: -

Identifier Source: org_study_id