Impact of Resistance Training Volume on Cognitive Function and Physical Performance in Cognitively Impaired Individuals

NCT06528951 | Active Not Recruiting

• 1 other identifier: Universidade da Beira Interior
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

This research project aims to analyze the effects of different resistance training volumes on cognitive function, oxidative stress, inflammatory markers, lipid profile, glycemic status, muscle damage, hemodynamic response, and physical performance in cognitively impaired participants. First, the participants will perform six weeks of resistance training using the same volume for all participants (control phase). The total training volume (sets x repetitions) will be 232 repetitions in the leg press and 160 repetitions in the chest press, with relative intensities ranging from 40% to 70% of 1RM. In week 7, the participants will perform the pre-test, and the outcome measures will be cognitive function, oxidative stress, inflammatory markers, lipid profile, glycemic status, muscle damage, hemodynamic response, and physical performance. After the pre-test, the participants will be randomly assigned into two training groups to perform a 10-week intervention. One group will increase the training volume by 15% concerning the training program performed in the control phase, while the other group will increase the volume by 30%. Participants will perform a control test one week after the intervention to assess hemodynamic parameters and physical performance. One week after the control test, the participants will perform another 10-week resistance training program, where the group that performed a volume of 15% will perform 30%, and the group that performed 30% will perform 45%. One week after the intervention, the participants will perform the post-test, and the outcome measures will be cognitive function, oxidative stress, inflammatory markers, lipid profile, glycemic status, muscle damage, hemodynamic response, and physical performance. The investigators hypothesize that both training volumes will induce similar adaptations in cognitive function, oxidative stress, immune response, lipid profile, glycemic status, muscle damage, hemodynamics, and physical performance in cognitively impaired individuals.

Conditions

Cognitive Impairment

Keywords

Dementia; Physical exercise; Volume; Functional performance; Healthy aging

Outcome Measures

Primary Outcomes (3)

• Short Physical Performance Battery

  The SPPB will determine the overall level of functional performance through three tests: balance (feet side by side, semi-tandem, tandem), 4-meter walking, and 5-repetition sit-to-stand.

  Change from baseline until week 29

• Dementia Rating Scale-2 (DRS-2)

  The DRS-2 questionnaire will be applied to analyze the overall level of cognitive function through five subscales: attention, initiation/perseveration, construction, conceptualization, and memory.

  Change from baseline until week 29

• Brain-Derived Neurotrophic Factor (BDNF)

  The BDNF protein levels will be analyzed through specific blood testing kits.

  Change from baseline until week 29

Secondary Outcomes (14)

• 1-kg Medicine Ball Throw (MBT)

  Change from baseline until week 29

• Handgrip strength (HGS)

  Change from baseline until week 29

• Ten-meters walking

  Change from baseline until week 29

• 1RM leg press and chest press

  Change from baseline until week 29

• Six-minute walking test

  Change from baseline until week 29

Study Arms (6)

Control Phase (6 Weeks)

EXPERIMENTAL

All recruited participants will perform 6 weeks of resistance training with the same volume. The total training volume (sets x repetitions) will be 232 repetitions in the leg press and 160 repetitions in the chest press, with relative intensities ranging from 40% to 70% of 1RM.

Other: Control Phase ( 6Weeks)

15% increase in resistance training volume (10 Weeks)

EXPERIMENTAL

The participants will perform 10 weeks of resistance training, increasing their initial volume by 15%.

Other: 15% increase in resistance training volume (10 Weeks)

30% increase in resistance training volume (10 Weeks)

EXPERIMENTAL

The participants will perform 10 weeks of resistance training, increasing their initial volume by 30%.

Other: 30% increase in resistance training volume (10 Weeks)

15% + 15% increase in resistance training volume (10 Weeks)

EXPERIMENTAL

The participants will perform 10 weeks of resistance training. The group that performed the 15% volume will increase to 30%.

Other: One group that performed 15% more volume and increased to 30% (10 Weeks)

30% + 15% increase in resistance training volume (10 Weeks)

EXPERIMENTAL

The participants will perform 10 weeks of resistance training. The group that performed the 30% volume will increase to 15%.

Other: One group that performed 30% more volume and increased to 45% (10 Weeks).

Control group ( 29 Weeks)

EXPERIMENTAL

The participants will not perform any form of physical exercise during the intervention period of twenty-nine weeks.

Other: Control group ( 29 Weeks)

Interventions

Control Phase ( 6Weeks) OTHER

The participants will perform a control phase of six weeks of resistance training using the same volume for the upper (160 repetitions) and lower limbs (230 repetitions), with relative intensities ranging from 40% to 70% of 1RM. The training sequence will be the following: i) 10 minutes of warmup walking on the treadmill, ii) 1-3 sets of 5-10 repetitions at 50-70% of 1RM in the leg press, iii) 1-3 sets of 5-10 repetitions at 40-60% 1RM in the chest press, iv) 1-3 sets of 6-10 repetitions in the sit-to-stand exercise, v) 1-3 sets of 5-7 repetitions in the 1- kg medicine ball throw, and vi) 5 minutes walking on the treadmill.

Control Phase (6 Weeks)

15% increase in resistance training volume (10 Weeks) OTHER

The participants will perform ten weeks of resistance training, increasing their initial volume by 15% (upper limbs - 184 repetitions; lower limbs - 268 repetitions). The number of sets will range from 1 to 3, and the relative intensities from 40% to 70% 1RM. The training sequence will be the following: i) 10 minutes of warmup walking on the treadmill, ii) 1-3 sets of 3-10 repetitions at 50-70% of 1RM in the leg press, iii) 1-3 sets of 3-10 repetitions at 40-60% 1RM in the chest press, iv) 1-3 sets of 4-10 repetitions in the sit-to-stand exercise, v) 1-3 sets of 3-8 repetitions in the 1- kg medicine ball throw, and vi) 5 minutes walking on the treadmill.

15% increase in resistance training volume (10 Weeks)

30% increase in resistance training volume (10 Weeks) OTHER

The participants will perform ten weeks of resistance training, increasing their initial volume by 30% (upper limbs - 208 repetitions; lower limbs - 300 repetitions). The number of sets will range from 1 to 3, and the relative intensities from 40% to 70% 1RM. The training sequence will be the following: i) 10 minutes of warmup walking on the treadmill, ii) 1-3 sets of 4-10 repetitions at 50-70% of 1RM in the leg press, iii) 1-3 sets of 4-10 repetitions at 40-60% 1RM in the chest press, iv) 1-3 sets of 5-10 repetitions in the sit-to-stand exercise, v) 1-3 sets of 4-7 repetitions in the 1- kg medicine ball throw, and vi) 5 minutes walking on the treadmill.

30% increase in resistance training volume (10 Weeks)

One group that performed 15% more volume and increased to 30% (10 Weeks) OTHER

The participants will perform 10 weeks of resistance training. The group that performed a 15% volume will now increase more by 15% and perform 30% (upper limbs - 208 repetitions; lower limbs - 300 repetitions). The number of sets will range from 1 to 3, and the relative intensities from 40% to 70% 1RM. The training sequence will be the following: i) 10 minutes of warmup walking on the treadmill, ii) 1-3 sets of 4-10 repetitions at 50-70% of 1RM in the leg press, iii) 1-3 sets of 4-10 repetitions at 40-60% 1RM in the chest press, iv) 1-3 sets of 5-10 repetitions in the sit-to-stand exercise, v) 1-3 sets of 4-7 repetitions in the 1- kg medicine ball throw, and vi) 5 minutes walking on the treadmill.

15% + 15% increase in resistance training volume (10 Weeks)

One group that performed 30% more volume and increased to 45% (10 Weeks). OTHER

The participants will perform 10 weeks of resistance training. The group that performed a 30% volume will now increase more by 15% and perform 45% (upper limbs - 232 repetitions; lower limbs - 334 repetitions). The number of sets will range from 1 to 3, and the relative intensities from 40% to 70% 1RM. The training sequence will be the following: i) 10 minutes of warmup walking on the treadmill, ii) 1-3 sets of 3-10 repetitions at 50-70% of 1RM in the leg press, iii) 1-3 sets of 3-10 repetitions at 40-60% 1RM in the chest press, iv) 2-3 sets of 8 repetitions in the sit-to-stand exercise, v) 2-3 sets of 8 repetitions in the 1- kg medicine ball throw, and vi) 5 minutes walking on the treadmill.

30% + 15% increase in resistance training volume (10 Weeks)

Control group ( 29 Weeks) OTHER

The participants in the control group will maintain their regular daily activities without performing any form of physical exercise.

Control group ( 29 Weeks)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged ≥ 50 years old, diagnosed with cognitive impairment (mild, moderate, or severe) through the Dementia Rating Scale-2.
• SPPB score ≥ 3.
• Willingness to participate in training programs and collaborate with the research team.
• Able to provide informed consent (oral or written).

You may not qualify if:

• Severe comorbidity that negatively influences participation in the training program.
• Surgeries or fractures in the last 6 months.
• Bedridden or hospitalized individuals.

Sponsors & Collaborators

• University of Beira Interior: lead
• Research Center in Sports Sciences, Health Sciences and Human Development: collaborator

Study Sites (1)

University of Beira Interior

Covilha, Portugal

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Mário M; Marques, PhD

  University of Beira Interior

  PRINCIPAL INVESTIGATOR

• Dulce Esteves, PhD

  University of Beira Interior

  PRINCIPAL INVESTIGATOR

• Mikel Izquierdo, PhD

  Universidad Pública de Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (Outcomes assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 30, 2024
• Study Start: October 28, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 29, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)