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

Obesity Clinical Trial

Official title:

Effects of a 24-week Remote-based Resistance Training Program on Parameters of the Metabolic Syndrome, Cognitive Function, and Quality of Life in Older Adults Living With Mild Cognitive Impairment and Alzheimer's Disease and/or a Related Dementia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05004558
• Other study ID #: THMA 2021-21
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: June 2022

Study information

• Verified date: August 2021
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. Measurements of resting blood pressure will be collected with an automated blood pressure monitor. Fasting blood glucose and lipids will be retrieved from the electronic medical record or from a finger stick. Waist and hip circumferences will be collected with a tape measure. Height and weight will be collected with a physician scale. Cognitive function and quality of life will be collected from interviews using the Montreal Cognitive Assessment and Short-Form (36) Health Survey. All data collected from this study will be de-identified using the "Safe-Harbor" method, which minimizes exposure of personal health information by providing each participant with a unique participant-ID and only providing access to those who are listed and approved for access privileges. Data collected for this study will also be stored on an encrypted and password- protected hard drive, and data analyzed will be performed with the Statistical Package for the Social Sciences using analyses of covariance.

When participants are enrolled in the study, he/she will be grouped on the basis of their cognitive function status from the Montreal Cognitive Assessment. All participants will then receive supervised remote-based resistance exercise training with Therabands, 3 days per week for 24 weeks. The risks of participating in exercise programs are minimal. Some of the possible risks of participating in resistance exercise include becoming tired and/or experiencing delayed onset muscle soreness, leg cramping, or muscle strain from performing resistance exercise. There are several benefits from engaging in resistance exercise programs. Participants of this study will receive health-fitness assessment at the beginning, middle, and end of the study, and as such, will benefit from being made aware of their cardiovascular disease risk factors, cognitive function, and quality of life. Other possible benefits from participation in the resistance exercise program may include improvements in muscular size and strength and/or activities of daily living.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: June 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• 55 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Aging
• Alzheimer Disease
• Aphasia, Primary Progressive
• Blood Glucose, High
• Blood Glucose, Low
• Blood Pressure
• Body Weight
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Dementia, Vascular
• Dyslipidemias
• Frontotemporal Dementia
• Hyperglycemia
• Hypertension
• Hypoglycemia
• Lewy Body Disease
• Mild Cognitive Impairment
• Obesity
• Obesity, Abdominal
• Pick Disease of the Brain
• Quality of Life

Intervention

Other:
• Remote-based Resistance Exercise Training
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Drexel University	Mercy Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Cognitive Function as Measured by the Montreal Cognitive Assessment	Cognitive function will be assessed with the Montreal Cognitive Assessment Screen, measured from 0 to 30 with higher scores indicating better cognitive function	Baseline
Secondary	Cognitive Function as Measured by the Montreal Cognitive Assessment	Cognitive function will be assessed with the Montreal Cognitive Assessment Screen, measured from 0 to 30 with higher scores indicating better cognitive function	12 weeks
Secondary	Cognitive Function as Measured by the Montreal Cognitive Assessment	Cognitive function will be assessed with the Montreal Cognitive Assessment Screen, measured from 0 to 30 with higher scores indicating better cognitive function	24 weeks
Secondary	Quality of Life as measured by the Short-Form (36) Health Survey	Quality of life will be assessed with the Short-Form (36) Health Survey, measured from 0 to 100 with higher scores indicating better quality of life	Baseline
Secondary	Quality of Life as measured by the Short-Form (36) Health Survey	Quality of life will be assessed with the Short-Form (36) Health Survey, measured from 0 to 100 with higher scores indicating better quality of life	12 weeks
Secondary	Quality of Life as measured by the Short-Form (36) Health Survey	Quality of life will be assessed with the Short-Form (36) Health Survey, measured from 0 to 100 with higher scores indicating better quality of life	24 weeks