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DementiaNCT05004558

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

A study testing Remote-based Resistance Exercise Training in people with Dementia and Alzheimer Disease, run by Drexel University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for
Dementia, Alzheimer Disease, Dementia, Vascular
What is being tested?
Remote-based Resistance Exercise Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
No sites listed yet
Study dates
1 Sep 2021to Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

About this study

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

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.

Read the 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.

Being tested
Remote-based Resistance Exercise Training
Medical subject headings
Dementia, Alzheimer Disease, Dementia, Vascular, Lewy Body Disease, Frontotemporal Dementia, Cognitive Dysfunction, Hypertension, Obesity, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote-based Resistance Exercise TrainingOther

    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.

Study groups in NCT05004558
Study groupRoleWhat they receive
Remote-based Resistance Exercise TrainingExperimentalAll 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.
Receives: Other: Remote-based Resistance Exercise Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline

  2. 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

    Measured: 12 weeks

  3. 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

    Measured: 24 weeks

  4. 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

    Measured: Baseline

  5. 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

    Measured: 12 weeks

  6. 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

    Measured: 24 weeks

  7. 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

    Measured: Baseline

  8. 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

    Measured: 12 weeks

  9. 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

    Measured: 24 weeks

  10. 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

    Measured: Baseline

  11. 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

    Measured: 12 weeks

  12. 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

    Measured: 24 weeks

  13. 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

    Measured: Baseline

  14. 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

    Measured: 12 weeks

  15. 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

    Measured: 24 weeks

  16. 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

    Measured: Baseline

  17. 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

    Measured: 12 weeks

  18. 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

    Measured: 24 weeks

  19. 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

    Measured: Baseline

  20. 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

    Measured: 12 weeks

  21. 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

    Measured: 24 weeks

  22. 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

    Measured: Baseline

  23. 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

    Measured: 12 weeks

  24. 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

    Measured: 24 weeks

  25. 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

    Measured: Baseline

  26. 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

    Measured: 12 weeks

  27. 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

    Measured: 24 weeks

  28. 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

    Measured: Baseline

  29. 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

    Measured: 12 weeks

  30. 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

    Measured: 24 weeks

  31. 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

    Measured: Baseline

  32. 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

    Measured: 12 weeks

  33. 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

    Measured: 24 weeks

  34. 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

    Measured: Baseline

  35. 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

    Measured: 12 weeks

  36. 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

    Measured: 24 weeks

Secondary outcomes (6)
  1. 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

    Measured: Baseline

  2. 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

    Measured: 12 weeks

  3. 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

    Measured: 24 weeks

  4. 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

    Measured: Baseline

  5. 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

    Measured: 12 weeks

  6. 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

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2021
  2. Study start1 Sep 2021 (estimated)
  3. Primary completionMar 2022 (estimated)
  4. Study completionJun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05004558
Sponsor's protocol ID
THMA 2021-21
Status last verified
Aug 2021
First submitted
21 May 2021
Last updated
13 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Remote-based Resistance Exercise Training in people with Dementia and Alzheimer Disease, run by Drexel University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resting systolic blood pressure, measured in mmHg from 0 and above with higher numbers indicating higher blood pressure (time frame: Baseline). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.

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