The Promotion of Physical Activity for the Prevention of Alzheimer's Disease in Adults With Down Syndrome

Alzheimer Disease Clinical Trial

Official title:

The Promotion of Physical Activity for the Prevention of Alzheimer's Disease in Adults With Down Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04048759
• Other study ID #: STUDY00143836
• Secondary ID: R01AG063909
• Status: Completed
• Phase: N/A
• Start date: January 21, 2020
• Est. completion date: November 22, 2023

Study information

• Verified date: November 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objectives of this study are to determine the feasibility and potential efficacy of remotely delivered group exercise sessions to increase daily moderate to vigorous physical activity in adults with Down syndrome, relative to a usual care control. Participants will be randomized to attend 40 min remotely delivered group moderate to vigorous physical activity (MVPA) sessions at low frequency (1 session/wk.,RL), high frequency (3 sessions/wk., RH), or usual care control usual care control (UC). In addition to the group MVPA sessions, participants in both the RL and RH groups will also receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk. Content for both the RL and RH arms will be identical with the exception of group session frequency (1 vs. 3/wk.). Participants in the UC arm will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education).The primary aim is to Assess daily MVPA (min) in the RL, RH, and UC arms at baseline, 3, 6, 9, and 12 mos., and obtain effect sizes for change in MVPA over 12-mos.Secondary Aim 1 is to assess the impact of MVPA on cardiovascular fitness, quality of life, cognitive function, and brain parameters related to Alzheimer's Disease (whole and regional brain volume, functional connectivity, and cerebral blood flow) at baseline, 6, and 12 mos. Secondary Aim 2 will determine the feasibility (retention, session attendance, use of recorded sessions (RH/RL only) of RL, RH, and UC interventions.

Description:

This research study will compare 3 strategies for the delivery of an intervention to increase moderate to vigorous physical activity (MVPA) in community dwelling adults with Down Syndrome; remotely delivered group MVPA sessions at low (1 session/wk.,RL), high frequency (3 sessions/wk., RH), or usual care control (UC). Adults (age ≥ 18 yrs.) with Down Syndrome will be randomized (2:2:1) to one of the 3 intervention arms for an 12-mo. trial. Cohorts of ~20 adults with Down Syndrome will be recruited and computer randomized. Participants will be stratified by sex and sequentially randomized by the study statistician. Participants in all arms will be provided with an iPad for intervention delivery, Fitbit for self-monitoring MPA, and will be asked to complete 150 min of MPA/wk. Participants in the RL and RH arms will be asked to complete 40 minutes MVPA sessions delivered via Zoom software on an iPad, RL will be provided 1 session/wk, and RH will be provided 3 sessions/wk. Participants in both the RL and RH groups will also receive one 20-min remotely delivered individual support/education session/wk. with a heath coach to discuss progress and provide support. The UC intervention will follow the traditional approach to promote increased MVPA. Participants will receive an iPad tablet loaded with information regarding increasing MVPA and will also receive resistance bands and a Fitbit for self-monitoring MVPA. Monthly 20-min. education/support sessions, identical to the education/support sessions provided in the RL and RH arms, will be delivered to participants and their caregivers remotely on the iPad using FaceTime. All outcomes will be collected by trained research assistants who are blinded to the study condition. The primary outcome, daily MVPA (min) in the RL, RH, and UC arms will be assessed at baseline, 3, 6, 9, and 12 mos. using an accelerometer. All secondary outcomes will be assessed at baselines, 6, and 12 months. Secondary outcomes are to assess the impact of MVPA across the RL, RH, and UC arms on cardiovascular fitness, quality of life, cognitive function and brain parameters related to Alzheimer's Disease (whole and regional brain volume, functional connectivity, cerebral blood flow). Additionally the researchers will determine the feasibility (retention, session attendance, use of recorded sessions (RH/RL only) and safety of RL, RH, and UC arms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: November 22, 2023
• Est. primary completion date: November 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age 18 and over.

• Diagnosis of DS as determined by a Community Service Provider operating in our recruitment area under the auspices of a Community Developmental Disability Organization (CDDO).

• Sufficient functional ability to understand directions, communicate preferences, wants and needs through spoken language.

• Living at home with a parent/guardian or in a supported living environment with a caregiver who agrees to serve as a study partner.

• No plans to relocate outside the study area over the next 12 mos.

• Internet access in the home.

Exclusion Criteria:

• Diagnosis of dementia as determine by the Cambridge Examination for Mental Disorders of Older People with Down Syndrome and others with intellectual disabilities.

• Unable to participate in MVPA.

• Pregnancy during the previous 6 mos., currently lactating or planned pregnancy in the following 12 mos.

• Serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty as determined by the PCP.

• Unwilling to be randomized.

• Participation in a regular exercise program, i.e. greater than or equal to 20 min/d greater than or equal to 3 d/wk.

• Contraindications for MRI, including metal implants or devices incompatible with MRI such as pacemakers, claustrophobia, and inability to lay in a supine position.

Related Conditions & MeSH terms

• Alzheimer Disease
• Down Syndrome
• Syndrome

Intervention

Behavioral:
• Remote Low
Participants will attend 40 min remotely delivered group MVPA sessions once a week, receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk.
• Remote High
Participants will attend 40 min remotely delivered group MVPA sessions 3x a week, receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk.
• Personal Coach
Participants will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight	Weight will be measured in light clothing on a calibrated scale (Model #PS6600, Belfour, Saukville, WI) to the nearest 0.1 kg.	Baseline to 12 months
Other	Height	Standing height will be measured with a portable stadiometer (Model #IP0955, Invicta Plastics Limited, Leicester, UK).	Baseline to 12 months
Other	Waist Circumference	Waist circumference will be assessed using a waist tape measure.	Baseline to 12 months
Other	Energy Expenditure of Exercise Sessions	The energy expenditure of sessions will be collected by a portable metabolic system at random timepoints across the 12 month study.	Baseline to 12 months
Other	Functional lower extremity strength	Functional lower extremity strength will be assessed using the Five Times Sit to Stand	Baseline to 12 months
Other	Functional mobility	Functional mobility will be assessed using the Timed Up and Go.	Baseline to 12 months
Other	Upper body strength	Upper body strength will be assessed using hand grip dynamometer	Baseline to 12 months
Other	Activities of daily living	Activities of daily living will be assessed using the Waisman Activities of Daily Living scale. This scale contains 17 questions, each item is rated as 0="does not do", 1="does with help", or 2="does independently / on own. A higher score indicates greater independence.	Baseline to 12 months
Other	Caregiver burden	Caregiver burden will be assess using The Modified Caregiver Strain Index. The tool has 13 questions that measure strain related to care provision. Scoring is 2 points for each 'yes', 1 point for each 'sometimes', and 0 for each 'no' response. Scoring ranges from 26 to 0; a higher score indicates a higher level of caregiver strain.	Baseline to 12 months
Other	Caregiver stress	Caregiver stress will be assessed by the Caregiver Self-Assessment Questionnaire. This questionnaire is 18 questions, 16 with yes or no responses, and 2 ranking questions. Typically a higher score indicates a higher level of caregiver stress.	Baseline to 12 months
Other	Caregiver quality of life	Caregiver quality of life will be assessed by the Adult Carer Quality of Life Questionnaire. The Adult Carer Quality of Life Questionnaire is a 40-item instrument that measures the overall quality of life for adult carers. Scores on the have a possible range of 0 to 120 with higher scores indicating greater quality of life.	Baseline to 12 months
Primary	Moderate to Vigorous Physical Activity (MVPA)	MVPA will be assessed at baseline (month 0), 3, 6, 9, and, 12 months, using an ActiGraph tri-axial accelerometer	Baseline to 12 months
Secondary	Cognitive Function	Working memory, processing speed, multitasking, and episodic memory will be assessed at baseline, 6 and, and 12 months, using tests selected from the widely used Cambridge Neuropsychological Test Automated Battery (CANTAB, Cambridge Cognition, LTD, Cambridge, UK) for Down syndrome. The CANTAB for Down syndrome uses a battery of tests including multitasking, episodic memory, executive function and processing speed.	Baseline to 12 months
Secondary	Cardiovascular fitness	Maximal treadmill tests (modified Balke protocol) will be completed at baseline, 6, and 12 months	Baseline to 12 months
Secondary	Change in Quality of Life	Quality of life will be assessed at baseline, 6, and 12 months with the Personal Well-Being Index Intellectual Disability, which contains 7 items, each corresponding to a quality of life domain: standard of living, health, life achievement, personal relationships, personal safety, community connectedness, and future security. Participants answer questions on a 0-4 scale, with 0 being least happy and 4 being most happy.	Baseline to 12 months
Secondary	Brain volume	Brain volume will be measured using structural MRI at baseline, 6, and 12 months	Baseline to 12 months
Secondary	Functional connectivity	Functional connectivity will be measured using resting state MRI (rsMRI) at baseline, 6, and 12 months.	Baseline to 12 months
Secondary	Cerebral blood flow	Functional connectivity will be measured using arterial spin labeling at baseline, 6, and 12 months	Baseline to 12 months
Secondary	Retention	Retention will be measured by the percentage of participants who complete the 12 month intervention, defined as completing the 12 month outcome assessments.	Baseline to 12 months
Secondary	Session attendance	Session attendance for both group MVPA and education/support sessions from baseline to 12 months will be obtained from records maintained by the health educator, and expressed as the percent of possible sessions. Attendance at group MVPA sessions will be defined as being logged in to the video conference and remaining on the screen for the entire 30-min session. Attendance at individual support/education sessions, for the both exercise and UC conditions, will be defined as answering the FaceTime call, and being present on screen for the entire session.	Baseline to 12 months
Secondary	Use of recorded exercise sessions	Use of recorded exercise sessions will be tracked using Dropbox which provides information on how many times each user watched a video.	Baseline to 12 months
Secondary	Reported Serious adverse event	Safety will be measured by number of participants reporting a serious adverse event, i.e., any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or results in persistent or significant disability/incapacity.	Baseline to 12 months