Clinical trial NCT05004558: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: Mercy Health
First posted: 2021-08-13
Enrollment: 36
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Resting systolic blood pressure, measured in mmHg from 0 and above with higher numbers indicating higher blood pressure
timeFrame: Baseline
measure: Resting systolic blood pressure, measured in mmHg from 0 and above with higher numbers indicating higher blood pressure
timeFrame: 12 weeks
measure: Resting systolic blood pressure, measured in mmHg from 0 and above with higher numbers indicating higher blood pressure
timeFrame: 24 weeks
measure: Resting diastolic blood pressure, measured in mmHg from 0 and above with higher numbers indicating higher blood pressure
timeFrame: Baseline
measure: Resting diastolic blood pressure, measured in mmHg from 0 and above with higher numbers indicating higher blood pressure
timeFrame: 12 weeks
measure: Resting diastolic blood pressure, measured in mmHg from 0 and above with higher numbers indicating higher blood pressure
timeFrame: 24 weeks
measure: Height, red with a stadiometer in inches from 0 and above with higher numbers indicating taller height
timeFrame: Baseline
measure: Height, red with a stadiometer in inches from 0 and above with higher numbers indicating taller height
timeFrame: 12 weeks
measure: Height, red with a stadiometer in inches from 0 and above with higher numbers indicating taller height
timeFrame: 24 weeks
measure: Weight, ured with a physican scale in pounds from 0 and above with higher numbers indicating heavier weight
timeFrame: Baseline
measure: Weight, ured with a physican scale in pounds from 0 and above with higher numbers indicating heavier weight
timeFrame: 12 weeks
measure: Weight, ured with a physican scale in pounds from 0 and above with higher numbers indicating heavier weight
timeFrame: 24 weeks
measure: Body mass index, measured in meters squared, from 0 and above wiith larger values indicating a higher body mass index
timeFrame: Baseline
measure: Body mass index, measured in meters squared, from 0 and above wiith larger values indicating a higher body mass index
timeFrame: 12 weeks
measure: Body mass index, measured in meters squared, from 0 and above wiith larger values indicating a higher body mass index
timeFrame: 24 weeks
measure: Waist circumference, red in inches with a Gulick tape measure from 0 and above with higher numbers indicating a larger waist circumference
timeFrame: Baseline
measure: Waist circumference, red in inches with a Gulick tape measure from 0 and above with higher numbers indicating a larger waist circumference
timeFrame: 12 weeks
measure: Waist circumference, red in inches with a Gulick tape measure from 0 and above with higher numbers indicating a larger waist circumference
timeFrame: 24 weeks
measure: Hip circumference, sured in inches with a Gulick tape measure from 0 and above with higher numbers indicating a larger waist circumference
timeFrame: Baseline
measure: Hip circumference, sured in inches with a Gulick tape measure from 0 and above with higher numbers indicating a larger waist circumference
timeFrame: 12 weeks
measure: Hip circumference, sured in inches with a Gulick tape measure from 0 and above with higher numbers indicating a larger waist circumference
timeFrame: 24 weeks
measure: Blood glucose, measured in mg/dL from 0 and above with larger values indicating a higher blood glucose concentration
timeFrame: Baseline
measure: Blood glucose, measured in mg/dL from 0 and above with larger values indicating a higher blood glucose concentration
timeFrame: 12 weeks
measure: Blood glucose, measured in mg/dL from 0 and above with larger values indicating a higher blood glucose concentration
timeFrame: 24 weeks
measure: 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
timeFrame: Baseline
measure: 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
timeFrame: 12 weeks
measure: 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
timeFrame: 24 weeks
measure: 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
timeFrame: Baseline
measure: 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
timeFrame: 12 weeks
measure: 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
timeFrame: 24 weeks
measure: Triglycerides, measured in mg/dL from 0 and above with larger values indicating a higher triglyceride concentrations, an undesirable finding
timeFrame: Baseline
measure: Triglycerides, measured in mg/dL from 0 and above with larger values indicating a higher triglyceride concentrations, an undesirable finding
timeFrame: 12 weeks
measure: Triglycerides, measured in mg/dL from 0 and above with larger values indicating a higher triglyceride concentrations, an undesirable finding
timeFrame: 24 weeks
measure: Total cholesterol, measured in mg/dL from 0 and above with larger values indicating a higher total cholesterol concentrations, an undesirable finding
timeFrame: Baseline
measure: Total cholesterol, measured in mg/dL from 0 and above with larger values indicating a higher total cholesterol concentrations, an undesirable finding
timeFrame: 12 weeks
measure: Total cholesterol, measured in mg/dL from 0 and above with larger values indicating a higher total cholesterol concentrations, an undesirable finding
timeFrame: 24 weeks
Secondary outcomes:
measure: Cognitive Function as Measured by the Montreal Cognitive Assessment
timeFrame: Baseline
measure: Cognitive Function as Measured by the Montreal Cognitive Assessment
timeFrame: 12 weeks
measure: Cognitive Function as Measured by the Montreal Cognitive Assessment
timeFrame: 24 weeks
measure: Quality of Life as measured by the Short-Form (36) Health Survey
timeFrame: Baseline
measure: Quality of Life as measured by the Short-Form (36) Health Survey
timeFrame: 12 weeks
measure: Quality of Life as measured by the Short-Form (36) Health Survey
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
References: