Effects of Remote-based Resistance Training on Cardiometabolic Risk Factors, Cognitive Function, and Quality of Life in Adults Living With Alzheimer's Disease and/or Related Dementias

NCT05004558 | Unknown DMC

• 1 other identifier: THMA 2021-21
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators aim to study the effects of a 24-week remote-based resistance exercise training program on cardiovascular disease risk factors, cognitive function, and quality of life in older adults living with mild cognitive impairment or Alzheimer's Disease and/or a related dementia. Data for this study will be collected at the beginning, middle, and end of the resistance training program. Participants of this study will receive a baseline health-fitness assessment at the beginning of the study. Measurements of resting blood pressure, fasting blood glucose and lipids, waist and hip circumferences, height and weight, cognitive function and quality of life will be collected at the health-fitness assessment. Participants will then receive supervised remote-based resistance exercise training with Therabands, 3 days per week for 12 weeks before receiving a second 12-week health-fitness assessment in the middle of the intervention. Participants will then receive 12 additional weeks of supervised remote-based resistance exercise training with Therabands, 3 days per week for 12 weeks before receiving a third 24-week health fitness assessment at the end of the study.

Conditions

Dementia; Alzheimer Disease; Dementia, Vascular; Lewy Body Disease; Frontotemporal Dementia; Mild Cognitive Impairment; Aging; Hypertension; Obesity, Abdominal; Obesity; Body Weight; Blood Pressure; Blood Glucose, High; Blood Glucose, Low; Dyslipidemias; Quality of Life; Cognitive Impairment

Outcome Measures

Primary Outcomes (36)

• Resting systolic blood pressure, measured in mmHg from 0 and above with higher numbers indicating higher blood pressure

  Resting systolic blood pressure will be measured with an automated blood pressure device, measured in mmHg from 0 and above with higher numbers indicating higher blood pressure

  Baseline

• Resting systolic blood pressure, measured in mmHg from 0 and above with higher numbers indicating higher blood pressure

  Resting systolic blood pressure will be measured with an automated blood pressure device, measured in mmHg from 0 and above with higher numbers indicating higher blood pressure

  12 weeks

• Resting systolic blood pressure, measured in mmHg from 0 and above with higher numbers indicating higher blood pressure

  Resting systolic blood pressure will be measured with an automated blood pressure device, measured in mmHg from 0 and above with higher numbers indicating higher blood pressure

  24 weeks

• Resting diastolic blood pressure, measured in mmHg from 0 and above with higher numbers indicating higher blood pressure

  Resting diastolic blood pressure will be measured with an automated blood pressure device, measured in mmHg from 0 and above with higher numbers indicating higher blood pressure

  Baseline

• Resting diastolic blood pressure, measured in mmHg from 0 and above with higher numbers indicating higher blood pressure

  Resting diastolic blood pressure will be measured with an automated blood pressure device, measured in mmHg from 0 and above with higher numbers indicating higher blood pressure

  12 weeks

• Resting diastolic blood pressure, measured in mmHg from 0 and above with higher numbers indicating higher blood pressure

  Resting diastolic blood pressure will be measured with an automated blood pressure device, measured in mmHg from 0 and above with higher numbers indicating higher blood pressure

  24 weeks

• Height, red with a stadiometer in inches from 0 and above with higher numbers indicating taller height

  Height will be measured with a stadiometer in inches from 0 and above with higher numbers indicating taller height

  Baseline

• Height, red with a stadiometer in inches from 0 and above with higher numbers indicating taller height

  Height will be measured with a stadiometer in inches from 0 and above with higher numbers indicating taller height

  12 weeks

• Height, red with a stadiometer in inches from 0 and above with higher numbers indicating taller height

  Height will be measured with a stadiometer in inches from 0 and above with higher numbers indicating taller height

  24 weeks

• Weight, ured with a physican scale in pounds from 0 and above with higher numbers indicating heavier weight

  Weight will be measured with a physican scale in pounds from 0 and above with higher numbers indicating heavier weight

  Baseline

• Weight, ured with a physican scale in pounds from 0 and above with higher numbers indicating heavier weight

  Weight will be measured with a physican scale in pounds from 0 and above with higher numbers indicating heavier weight

  12 weeks

• Weight, ured with a physican scale in pounds from 0 and above with higher numbers indicating heavier weight

  Weight will be measured with a physican scale in pounds from 0 and above with higher numbers indicating heavier weight

  24 weeks

• Body mass index, measured in meters squared, from 0 and above wiith larger values indicating a higher body mass index

  Body mass index will be measured as the weight measured in kilograms divided by the height measured in meters squared, from 0 and above wiith larger values indicating a higher body mass index

  Baseline

• Body mass index, measured in meters squared, from 0 and above wiith larger values indicating a higher body mass index

  Body mass index will be measured as the weight measured in kilograms divided by the height measured in meters squared, from 0 and above wiith larger values indicating a higher body mass index

  12 weeks

• Body mass index, measured in meters squared, from 0 and above wiith larger values indicating a higher body mass index

  Body mass index will be measured as the weight measured in kilograms divided by the height measured in meters squared, from 0 and above wiith larger values indicating a higher body mass index

  24 weeks

• Waist circumference, red in inches with a Gulick tape measure from 0 and above with higher numbers indicating a larger waist circumference

  Waist circumference will be measured in inches with a Gulick tape measure from 0 and above with higher numbers indicating a larger waist circumference

  Baseline

• Waist circumference, red in inches with a Gulick tape measure from 0 and above with higher numbers indicating a larger waist circumference

  Waist circumference will be measured in inches with a Gulick tape measure from 0 and above with higher numbers indicating a larger waist circumference

  12 weeks

• Waist circumference, red in inches with a Gulick tape measure from 0 and above with higher numbers indicating a larger waist circumference

  Waist circumference will be measured in inches with a Gulick tape measure from 0 and above with higher numbers indicating a larger waist circumference

  24 weeks

• Hip circumference, sured in inches with a Gulick tape measure from 0 and above with higher numbers indicating a larger waist circumference

  Hip circumference will be measured in inches with a Gulick tape measure from 0 and above with higher numbers indicating a larger waist circumference

  Baseline

• Hip circumference, sured in inches with a Gulick tape measure from 0 and above with higher numbers indicating a larger waist circumference

  Hip circumference will be measured in inches with a Gulick tape measure from 0 and above with higher numbers indicating a larger waist circumference

  12 weeks

• Hip circumference, sured in inches with a Gulick tape measure from 0 and above with higher numbers indicating a larger waist circumference

  Hip circumference will be measured in inches with a Gulick tape measure from 0 and above with higher numbers indicating a larger waist circumference

  24 weeks

• Blood glucose, measured in mg/dL from 0 and above with larger values indicating a higher blood glucose concentration

  Blood glucose will be measured with a Cholestech LDX analyzer via finger sticking, measured in mg/dL from 0 and above with larger values indicating a higher blood glucose concentration

  Baseline

• Blood glucose, measured in mg/dL from 0 and above with larger values indicating a higher blood glucose concentration

  Blood glucose will be measured with a Cholestech LDX analyzer via finger sticking, measured in mg/dL from 0 and above with larger values indicating a higher blood glucose concentration

  12 weeks

• Blood glucose, measured in mg/dL from 0 and above with larger values indicating a higher blood glucose concentration

  Blood glucose will be measured with a Cholestech LDX analyzer via finger sticking, measured in mg/dL from 0 and above with larger values indicating a higher blood glucose concentration

  24 weeks

• High density lipoprotein cholesterol, ed in mg/dL from 0 and above with larger values indicating a higher high density lipoprotein concentrations, a desirable finding

  High density lipoprotein cholesterol will be measured with a Cholestech LDX analyzer via finger sticking, measured in mg/dL from 0 and above with larger values indicating a higher high density lipoprotein concentrations, a desirable finding

  Baseline

• High density lipoprotein cholesterol, ed in mg/dL from 0 and above with larger values indicating a higher high density lipoprotein concentrations, a desirable finding

  High density lipoprotein cholesterol will be measured with a Cholestech LDX analyzer via finger sticking, measured in mg/dL from 0 and above with larger values indicating a higher high density lipoprotein concentrations, a desirable finding

  12 weeks

• High density lipoprotein cholesterol, ed in mg/dL from 0 and above with larger values indicating a higher high density lipoprotein concentrations, a desirable finding

  High density lipoprotein cholesterol will be measured with a Cholestech LDX analyzer via finger sticking, measured in mg/dL from 0 and above with larger values indicating a higher high density lipoprotein concentrations, a desirable finding

  24 weeks

• Low density lipoprotein cholesterol, measured in mg/dL from 0 and above with larger values indicating a higher low density lipoprotein concentrations, an undesirable finding

  Low density lipoprotein cholesterol will be measured with a Cholestech LDX analyzer via finger sticking, measured in mg/dL from 0 and above with larger values indicating a higher low density lipoprotein concentrations, an undesirable finding

  Baseline

• Low density lipoprotein cholesterol, measured in mg/dL from 0 and above with larger values indicating a higher low density lipoprotein concentrations, an undesirable finding

  Low density lipoprotein cholesterol will be measured with a Cholestech LDX analyzer via finger sticking, measured in mg/dL from 0 and above with larger values indicating a higher low density lipoprotein concentrations, an undesirable finding

  12 weeks

• Low density lipoprotein cholesterol, measured in mg/dL from 0 and above with larger values indicating a higher low density lipoprotein concentrations, an undesirable finding

  Low density lipoprotein cholesterol will be measured with a Cholestech LDX analyzer via finger sticking, measured in mg/dL from 0 and above with larger values indicating a higher low density lipoprotein concentrations, an undesirable finding

  24 weeks

• Triglycerides, measured in mg/dL from 0 and above with larger values indicating a higher triglyceride concentrations, an undesirable finding

  Triglycerides will be measured with a Cholestech LDX analyzer via finger sticking, measured in mg/dL from 0 and above with larger values indicating a higher triglyceride concentrations, an undesirable finding

  Baseline

• Triglycerides, measured in mg/dL from 0 and above with larger values indicating a higher triglyceride concentrations, an undesirable finding

  Triglycerides will be measured with a Cholestech LDX analyzer via finger sticking, measured in mg/dL from 0 and above with larger values indicating a higher triglyceride concentrations, an undesirable finding

  12 weeks

• Triglycerides, measured in mg/dL from 0 and above with larger values indicating a higher triglyceride concentrations, an undesirable finding

  Triglycerides will be measured with a Cholestech LDX analyzer via finger sticking, measured in mg/dL from 0 and above with larger values indicating a higher triglyceride concentrations, an undesirable finding

  24 weeks

• Total cholesterol, measured in mg/dL from 0 and above with larger values indicating a higher total cholesterol concentrations, an undesirable finding

  Total cholesterol will be measured with a Cholestech LDX analyzer via finger sticking, measured in mg/dL from 0 and above with larger values indicating a higher total cholesterol concentrations, an undesirable finding

  Baseline

• Total cholesterol, measured in mg/dL from 0 and above with larger values indicating a higher total cholesterol concentrations, an undesirable finding

  Total cholesterol will be measured with a Cholestech LDX analyzer via finger sticking, measured in mg/dL from 0 and above with larger values indicating a higher total cholesterol concentrations, an undesirable finding

  12 weeks

• Total cholesterol, measured in mg/dL from 0 and above with larger values indicating a higher total cholesterol concentrations, an undesirable finding

  Total cholesterol will be measured with a Cholestech LDX analyzer via finger sticking, measured in mg/dL from 0 and above with larger values indicating a higher total cholesterol concentrations, an undesirable finding

  24 weeks

Secondary Outcomes (6)

• Cognitive Function as Measured by the Montreal Cognitive Assessment

  Baseline

• Cognitive Function as Measured by the Montreal Cognitive Assessment

  12 weeks

• Cognitive Function as Measured by the Montreal Cognitive Assessment

  24 weeks

• Quality of Life as measured by the Short-Form (36) Health Survey

  Baseline

• Quality of Life as measured by the Short-Form (36) Health Survey

  12 weeks

Study Arms (1)

Remote-based Resistance Exercise Training

EXPERIMENTAL

All participants enrolled in the trial will receive supervised remote-based resistance exercise training. The exercises will be performed with the use of Therabands and will include 8-10 exercises performed for 1 set of 15 repetitions, performed 3 days per week for 24 weeks.

Other: Remote-based Resistance Exercise Training

Interventions

Remote-based Resistance Exercise Training OTHER

All participants enrolled in the trial will receive supervised remote-based resistance exercise training. The exercises will be performed with the use of Therabands and will include 8-10 exercises performed for 1 set of 15 repetitions, performed 3 days per week for 24 weeks.

Remote-based Resistance Exercise Training

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Sedentary or not meeting the current physical activity guidelines of at least 150 minutes of moderate-to-vigorous physical activity per week
• Live with or have a primary in-home caregiver or legal representative who can be physically present during the remote-based exercise sessions
• Have access to a computer, tablet, or smartphone with internet and webcam access for the HIPAA compliant virtual Zoom meetings.

You may not qualify if:

• Younger than 55 years of age
• Accustomed to resistance exercise training during the previous year
• Live with known or suggestive uncontrolled cardiovascular, metabolic, and/or renal disease
• Live with musculoskeletal injury that precludes their ability to perform remote-based, resistance exercise training

Sponsors & Collaborators

• Drexel University: lead
• Mercy Health: collaborator

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Dementia, Vascular; Lewy Body Disease; Frontotemporal Dementia; Cognitive Dysfunction; Hypertension; Obesity, Abdominal; Obesity; Body Weight; Dyslipidemias

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Cognition Disorders; Overweight; Overnutrition; Nutrition Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: August 13, 2021
• Study Start: September 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: August 13, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share