Resistance Training to Individuals for Cognitive Impairment With Dementia

NCT ID: NCT06185010

Last Updated: 2024-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This research project aims to analyze the effects of different resistance training volumes on cognitive function, oxidative stress, immunological response, lipid profile, glycemic status, liver function, muscle function, hemodynamic response, and physical performance in individuals with mild cognitive impairment. First the investigators will analyze the effects of a single resistance training session (acute effects) with one and three sets on hemodynamic and physical performance in individuals with mild cognitive impairment. After, the investigators will analyze the effects of an 8-week resistance training program with one or three sets on cognitive function, oxidative stress, immunological response, lipid profile, glycemic status, liver function, muscle function, hemodynamic response, and physical performance in individuals with mild cognitive impairment. The investigators hypothesize that a single resistance training session of one or three sets will increase the acute hemodynamic and physical performance stress in individuals with mild cognitive impairment, although with a higher magnitude in the session with three sets. Furthermore, we hypothesize that eight weeks of resistance training with one or three sets will induce similar improvements in cognitive function, oxidative stress, immunological response, lipid profile, glycemic status, liver function, muscle function, hemodynamic response, and physical performance in individuals with mild cognitive impairment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Following specific inclusion and exclusion criteria (see Eligibility Criteria), participants will be recruited from residential care facilities or day centers. For the acute effects study (cross-over study), participants will randomly perform two resistance training sessions separated by one week of rest: i) one session with one set and ii) another session of three sets. The intensity of the exercises, number of repetitions, type and order of exercises, movement velocity, and rest time between exercises will be the same in both groups. Before, immediately after, and 72 hours after the sessions, a battery of tests will be applied to evaluate the changes in blood pressure, heart rate, tympanic temperature, medicine ball throw distance, five-repetition sit-to-stand time, and handgrip strength. Afterward, participants will be randomly assigned into a one-set or three-set group to perform an eight-week resistance training intervention. As for the acute effects study, the prescription of the other acute training variables will be the same for both groups. A control group (without any form of physical exercise), recruited at the beginning of the research project, will also be part of the study. Before and after the intervention, a battery of tests will be applied to determine the training program's impact on cognitive function, oxidative stress, immunological response, lipid profile, glycemic status, liver function, muscle function, hemodynamic response, and physical performance in individuals with mild cognitive impairment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Cognitive Impairment Mild Dementia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

One Resistance Training Set (Single Session)

The participants will perform one resistance training session with one set.

Group Type EXPERIMENTAL

One Resistance Training Set (Single Session)

Intervention Type OTHER

The participants will perform a resistance training session with one set per exercise. The training sequence will be the following: i) 10 minutes of warm-up walking on the treadmill at 50% of maximal walking velocity, ii) 1 set of 10 repetitions at 60% of one-repetition maximum (1RM) in the leg press, iii) 1 set of 10 repetitions at 55% 1RM in the chest press, iv) 1 set of 10 repetitions in the sit-to-stand exercise, v) 1 set of 10 repetitions in the 1-kg medicine ball throw exercise, and vi) 5 minutes walking on the treadmill at 60% of maximal walking velocity.

Three Resistance Training Sets (Single Session)

The participants will perform one resistance training session with three sets.

Group Type EXPERIMENTAL

Three Resistance Training Sets (Single Session)

Intervention Type OTHER

The participants will perform a resistance training session with three sets per exercise. The training sequence will be the following: i) 10 minutes of warm-up walking on the treadmill at 50% of maximal walking velocity, ii) 3 sets of 10 repetitions at 60% of one-repetition maximum (1RM) in the leg press, iii) 3 sets of 10 repetitions at 55% 1RM in the chest press, iv) 3 sets of 10 repetitions in the sit-to-stand exercise, v) 3 sets of 10 repetitions in the 1-kg medicine ball throw exercise, and vi) 5 minutes walking on the treadmill at 60% of maximal walking velocity.

One Resistance Training Set (8 Weeks)

The participants will perform eight weeks of resistance training (two sessions per week, separated by 72 hours of rest) with one set.

Group Type EXPERIMENTAL

One Resistance Training Set (8 Weeks)

Intervention Type OTHER

The participants will perform eight weeks of resistance training with one set per exercise. The training sequence will be the following: i) 10 minutes of warm-up walking on the treadmill at 50% of maximal walking velocity, ii) 1 set of 10 repetitions between 50-70% of one-repetition maximum (1RM) in the leg press, iii) 1 set of 10 repetitions between 40-60% 1RM in the chest press, iv) 1 set of 6-12 repetitions in the sit-to-stand exercise, v) 1 set of 6-12 repetitions in the 1-kg medicine ball throw exercise, and vi) 5 minutes walking on the treadmill at 60% of maximal walking velocity.

Three Resistance Training Sets (8 Weeks)

The participants will perform eight weeks of resistance training (two sessions per week, separated by 72 hours of rest) with three sets.

Group Type EXPERIMENTAL

Three Resistance Training Sets (8 Weeks)

Intervention Type OTHER

The participants will perform eight weeks of resistance training with three sets per exercise. The training sequence will be the following: i) 10 minutes of warm-up walking on the treadmill at 50% of maximal walking velocity, ii) 3 sets of 10 repetitions between 50-70% of one-repetition maximum (1RM) in the leg press, iii) 3 sets of 10 repetitions between 40-60% 1RM in the chest press, iv) 3 sets of 6-12 repetitions in the sit-to-stand exercise, v) 3 sets of 6-12 repetitions in the 1-kg medicine ball throw exercise, and vi) 5 minutes walking on the treadmill at 60% of maximal walking velocity.

Control (8 Weeks)

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

Group Type EXPERIMENTAL

Control (8 Weeks)

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

One Resistance Training Set (Single Session)

The participants will perform a resistance training session with one set per exercise. The training sequence will be the following: i) 10 minutes of warm-up walking on the treadmill at 50% of maximal walking velocity, ii) 1 set of 10 repetitions at 60% of one-repetition maximum (1RM) in the leg press, iii) 1 set of 10 repetitions at 55% 1RM in the chest press, iv) 1 set of 10 repetitions in the sit-to-stand exercise, v) 1 set of 10 repetitions in the 1-kg medicine ball throw exercise, and vi) 5 minutes walking on the treadmill at 60% of maximal walking velocity.

Intervention Type OTHER

Three Resistance Training Sets (Single Session)

The participants will perform a resistance training session with three sets per exercise. The training sequence will be the following: i) 10 minutes of warm-up walking on the treadmill at 50% of maximal walking velocity, ii) 3 sets of 10 repetitions at 60% of one-repetition maximum (1RM) in the leg press, iii) 3 sets of 10 repetitions at 55% 1RM in the chest press, iv) 3 sets of 10 repetitions in the sit-to-stand exercise, v) 3 sets of 10 repetitions in the 1-kg medicine ball throw exercise, and vi) 5 minutes walking on the treadmill at 60% of maximal walking velocity.

Intervention Type OTHER

One Resistance Training Set (8 Weeks)

The participants will perform eight weeks of resistance training with one set per exercise. The training sequence will be the following: i) 10 minutes of warm-up walking on the treadmill at 50% of maximal walking velocity, ii) 1 set of 10 repetitions between 50-70% of one-repetition maximum (1RM) in the leg press, iii) 1 set of 10 repetitions between 40-60% 1RM in the chest press, iv) 1 set of 6-12 repetitions in the sit-to-stand exercise, v) 1 set of 6-12 repetitions in the 1-kg medicine ball throw exercise, and vi) 5 minutes walking on the treadmill at 60% of maximal walking velocity.

Intervention Type OTHER

Three Resistance Training Sets (8 Weeks)

The participants will perform eight weeks of resistance training with three sets per exercise. The training sequence will be the following: i) 10 minutes of warm-up walking on the treadmill at 50% of maximal walking velocity, ii) 3 sets of 10 repetitions between 50-70% of one-repetition maximum (1RM) in the leg press, iii) 3 sets of 10 repetitions between 40-60% 1RM in the chest press, iv) 3 sets of 6-12 repetitions in the sit-to-stand exercise, v) 3 sets of 6-12 repetitions in the 1-kg medicine ball throw exercise, and vi) 5 minutes walking on the treadmill at 60% of maximal walking velocity.

Intervention Type OTHER

Control (8 Weeks)

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinical diagnosis of mild cognitive impairment
* SPPB score ≥ 3 points
* Willingness to participate in the interventions and collaborate with the research team
* Must be able to provide informed consent (oral or written)

Exclusion Criteria

* Severe dementia
* Severe comorbidity that negatively influences participation in the intervention
* Color blindness
* Fractures in the last three months
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Research Center in Sports Sciences, Health Sciences and Human Development

OTHER

Sponsor Role collaborator

University of Beira Interior

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nuno Miguel Pintassilgo da Silva Fonseca

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mário C Marques, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Beira Interior

Dulce Esteves, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Beira Interior

Mikel Izquierdo, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Pública de Navarra

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Beira Interior

Covilha, , Portugal

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Portugal

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nuno Fonseca, Master's

Role: CONTACT

918241354 ext. +351

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nuno Fonseca

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Fonseca N, Esteves D, Marques DL, Fail LB, Sousa T, Pinto MP, Neiva HP, Izquierdo M, Marques MC. Acute and time-course changes in hemodynamic and physical performance parameters following single and multiple resistance training sets in cognitively impaired individuals: A randomized crossover study. Exp Gerontol. 2025 Mar;201:112688. doi: 10.1016/j.exger.2025.112688. Epub 2025 Jan 23.

Reference Type DERIVED
PMID: 39854950 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

University of Beira Interior

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Effectiveness of a Dual-task Training Program
NCT06450119 NOT_YET_RECRUITING NA