Resistance Training to Individuals for Cognitive Impairment With Dementia

NCT06185010 | Recruiting

• 1 other identifier: University of Beira Interior
• Study Type: interventional
• Target: 80
• 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, 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.

Conditions

Mild Cognitive Impairment; Mild Dementia

Outcome Measures

Primary Outcomes (5)

• Systolic blood pressure (SBP)

  In the cross-over study (acute effects), the SBP will be assessed through a blood pressure device.

  Change from baseline to 0 minutes and 72 hours after the sessions

• Handgrip strength (HGS)

  In the cross-over study (acute effects), the HGS will be assessed through an analogic dynamometer.

  Change from baseline to 0 minutes and 72 hours after the sessions

• Dementia Rating Scale-2 (DRS-2)

  In the eight-week study, 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 to week 8

• Brain-Derived Neurotrophic Factor (BDNF)

  In the eight-week study, the BDNF protein levels will be analyzed through specific blood testing kits.

  Change from baseline to week 8

• Short Physical Performance Battery (SPPB)

  In the eight-week study, 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 8

Secondary Outcomes (16)

• Diastolic blood pressure (DBP)

  Change from baseline to 0 minutes and 72 hours after the sessions

• Heart rate (HR)

  Change from baseline to 0 minutes and 72 hours after the sessions

• Tympanic temperature (TT)

  Change from baseline to 0 minutes and 72 hours after the sessions

• Five-repetition sit-to-stand (5STS)

  Change from baseline to 0 minutes and 72 hours after the sessions

• 1-kg Medicine Ball Throw (MBT)

  Change from baseline to 0 minutes and 72 hours after the sessions

Study Arms (5)

One Resistance Training Set (Single Session)

EXPERIMENTAL

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

Other: One Resistance Training Set (Single Session)

Three Resistance Training Sets (Single Session)

EXPERIMENTAL

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

Other: Three Resistance Training Sets (Single Session)

One Resistance Training Set (8 Weeks)

EXPERIMENTAL

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

Other: One Resistance Training Set (8 Weeks)

Three Resistance Training Sets (8 Weeks)

EXPERIMENTAL

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

Other: Three Resistance Training Sets (8 Weeks)

Control (8 Weeks)

EXPERIMENTAL

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

Other: Control (8 Weeks)

Interventions

One Resistance Training Set (Single Session) 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.

One Resistance Training Set (Single Session)

Three Resistance Training Sets (Single Session) 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.

Three Resistance Training Sets (Single Session)

One Resistance Training Set (8 Weeks) 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.

One Resistance Training Set (8 Weeks)

Three Resistance Training Sets (8 Weeks) 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.

Three Resistance Training Sets (8 Weeks)

Control (8 Weeks) OTHER

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

Control (8 Weeks)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Severe dementia
• Severe comorbidity that negatively influences participation in the intervention
• Color blindness
• Fractures in the last three months

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

RECRUITING

Related Publications (1)

• 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.

  PMID: 39854950 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Mário C 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

Central Study Contacts

Nuno Fonseca, Master's

CONTACT

918241354; nuno1977fonseca@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 29, 2023
• Study Start: December 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)