Resistance Training for Individuals With Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

— TRAIN4BRAIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06185010
• Other study ID #: University of Beira Interior
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: April 2024

Study information

• Verified date: December 2023
• Source: University of Beira Interior
• Contact: Nuno Fonseca, Master's
• Phone: 918241354
• Email: nuno1977fonseca[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment
• Mild Dementia

Intervention

Other:
• 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.
• 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.
• 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.
• 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.
• Control (8 Weeks)
The participants in the control group will maintain their regular daily activities without performing any form of physical exercise.

Locations

Country	Name	City	State
Portugal	University of Beira Interior	Covilhã

Sponsors (2)

Lead Sponsor	Collaborator
University of Beira Interior	Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD)

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Diastolic blood pressure (DBP)	In the cross-over study (acute effects), the DBP will be assessed through a blood pressure device.	Change from baseline to 0 minutes and 72 hours after the sessions
Secondary	Heart rate (HR)	In the cross-over study (acute effects), the HR will be assessed through a blood pressure device.	Change from baseline to 0 minutes and 72 hours after the sessions
Secondary	Tympanic temperature (TT)	In the cross-over study (acute effects), the TT will be assessed through a tympanic thermometer.	Change from baseline to 0 minutes and 72 hours after the sessions
Secondary	Five-repetition sit-to-stand (5STS)	In the cross-over study (acute effects), the 5STS time will be recorded through a chronometer.	Change from baseline to 0 minutes and 72 hours after the sessions
Secondary	1-kg Medicine Ball Throw (MBT)	In the cross-over study (acute effects), the MBT distance will be recorded with a tape measure.	Change from baseline to 0 minutes and 72 hours after the sessions
Secondary	Inflammatory markers	In the eight-week study, inflammatory markers (IL-6, TNF-a, and IL-10) will be analyzed through specific blood testing kits.	Change from baseline to week 8
Secondary	Oxidative stress	In the eight-week study, oxidative stress markers (carbonylated proteins) will be analyzed through specific blood testing kits.	Change from baseline to week 8
Secondary	Lipid Profile	In the eight-week study, the lipid profile (LDL, HDL, total cholesterol, triglycerides) will be analyzed through specific blood testing kits.	Change from baseline to week 8
Secondary	HbA1c	In the eight-week study, the HbA1c will be analyzed through specific blood testing kits.	Change from baseline to week 8
Secondary	Muscle Damage	In the eight-week study, the muscle damage (creatine kinase, lactate dehydrogenase, aspartate aminotransferase, and alanine aminotransferase) will be analyzed through specific blood testing kits.	Change from baseline to week 8
Secondary	One-repetition maximum (1RM)	In the eight-week study, a progressive loading test until reaching the 1RM will be applied in the horizontal leg press and seated chest press machines.	Change from baseline to week 8
Secondary	Load-velocity profiles	In the eight-week study, the load-velocity profiles will be analyzed using the velocity values (recorded with a linear velocity transducer) associated with the absolute loads used during the progressive loading tests in the horizontal leg press and seated chest press machines.	Change from baseline to week 8
Secondary	Ten-meters walking	In the eight-week study, the 10-meter walking time will be measured through a chronometer.	Change from baseline to week 8
Secondary	1-kg Medicine Ball Throw (MBT)	In the eight-week study, the MBT distance will be recorded with a tape measure.	Change from baseline to week 8
Secondary	Handgrip strength (HGS)	In the eight-week study, the HGS will be assessed through an analogic dynamometer.	Change from baseline to week 8
Secondary	6-Minute Walk Test (6MWT)	In the eight-week study, the 6MWT distance will be assessed by multiplying the number of total laps by the lap distance (e.g., 10 laps x 10 meters).	Change from baseline to week 8