Trial Outcomes & Findings for The Promotion of Physical Activity for the Prevention of Alzheimer's Disease in Adults With Down Syndrome (NCT NCT04048759)

NCT ID: NCT04048759

Last Updated: 2024-07-23

Results Overview

MVPA was assessed using an ActiGraph tri-axial accelerometer.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

81 participants

Primary outcome timeframe

Baseline to 12 months

Results posted on

2024-07-23

Participant Flow

Participant milestones

Participant milestones
Measure	Remote High 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.	Remote Low 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.	Personal Coach Personal Coach: Participants will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education.
Overall Study STARTED	34	32	15
Overall Study 6 Month Assessment	34	32	15
Overall Study 12 Month Assessment	34	32	15
Overall Study COMPLETED	34	32	15
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Remote High n=34 Participants 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.	Remote Low n=32 Participants 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.	Personal Coach n=15 Participants Personal Coach: Participants will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education.	Total n=81 Participants Total of all reporting groups
Age, Continuous	25.5 years STANDARD_DEVIATION 8.5 • n=5 Participants	27.8 years STANDARD_DEVIATION 10.4 • n=7 Participants	26.6 years STANDARD_DEVIATION 6.6 • n=5 Participants	26.6 years STANDARD_DEVIATION 8.9 • n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	19 Participants n=7 Participants	7 Participants n=5 Participants	45 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	13 Participants n=7 Participants	8 Participants n=5 Participants	36 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants	29 Participants n=7 Participants	14 Participants n=5 Participants	74 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	21 Participants n=7 Participants	15 Participants n=5 Participants	68 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	34 participants n=5 Participants	32 participants n=7 Participants	15 participants n=5 Participants	81 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to 12 months

Population: Only participants who had valid accelerometer wear time (8 hrs a day for at least 3 weekdays/1weekend day) are included at each timepoint.

MVPA was assessed using an ActiGraph tri-axial accelerometer.

Outcome measures

Outcome measures
Measure	Remote High n=34 Participants 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.	Remote Low n=32 Participants 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.	Personal Coach n=15 Participants Personal Coach: Participants will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education.
Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day Absolute MVPA at 6 months	26.1 min of MVPA/day Standard Deviation 24.4	15.9 min of MVPA/day Standard Deviation 15.7	20.0 min of MVPA/day Standard Deviation 18.6
Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day Absolute MVPA at 12 months	24.4 min of MVPA/day Standard Deviation 23.5	14.7 min of MVPA/day Standard Deviation 16.7	17.0 min of MVPA/day Standard Deviation 13.9
Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day Absolute MVPA at Baseline	13.8 min of MVPA/day Standard Deviation 13.9	17.9 min of MVPA/day Standard Deviation 29.6	15.6 min of MVPA/day Standard Deviation 15.8
Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day Absolute MVPA at 3 months	21.8 min of MVPA/day Standard Deviation 19.3	13.8 min of MVPA/day Standard Deviation 12.6	19.9 min of MVPA/day Standard Deviation 18.3
Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day Absolute MVPA at 9 months	23.9 min of MVPA/day Standard Deviation 21.4	19.5 min of MVPA/day Standard Deviation 24.9	17.9 min of MVPA/day Standard Deviation 17.0

SECONDARY outcome

Timeframe: Baseline to 12 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months

Maximal treadmill tests (modified Balke protocol) will be completed at baseline, 6, and 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months

Brain volume will be measured using structural MRI at baseline, 6, and 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months

Functional connectivity will be measured using resting state MRI (rsMRI) at baseline, 6, and 12 months.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months

Functional connectivity will be measured using arterial spin labeling at baseline, 6, and 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months

Retention will be measured by the percentage of participants who complete the 12 month intervention, defined as completing the 12 month outcome assessments.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months

Use of recorded exercise sessions will be tracked using Dropbox which provides information on how many times each user watched a video.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

Weight will be measured in light clothing on a calibrated scale (Model #PS6600, Belfour, Saukville, WI) to the nearest 0.1 kg.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

Standing height will be measured with a portable stadiometer (Model #IP0955, Invicta Plastics Limited, Leicester, UK).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

Waist circumference will be assessed using a waist tape measure.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

The energy expenditure of sessions will be collected by a portable metabolic system at random timepoints across the 12 month study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

Functional lower extremity strength will be assessed using the Five Times Sit to Stand

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

Functional mobility will be assessed using the Timed Up and Go.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

Upper body strength will be assessed using hand grip dynamometer

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

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.

Outcome measures

Outcome data not reported

Adverse Events

Remote High

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Remote Low

Serious events: 3 serious events

Other events: 1 other events

Deaths: 0 deaths

Personal Coach

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Remote High n=34 participants at risk 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.	Remote Low n=32 participants at risk 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.	Personal Coach n=15 participants at risk Personal Coach: Participants will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education.
Gastrointestinal disorders Cholecystectomy	2.9% 1/34 • Number of events 1 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.	0.00% 0/32 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.	0.00% 0/15 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.
Cardiac disorders Mitral Valve Regurgitation	0.00% 0/34 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.	3.1% 1/32 • Number of events 1 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.	0.00% 0/15 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/34 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.	3.1% 1/32 • Number of events 1 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.	0.00% 0/15 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.
Immune system disorders Appendectomy	0.00% 0/34 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.	3.1% 1/32 • Number of events 1 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.	0.00% 0/15 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.
Infections and infestations Spinal infection	2.9% 1/34 • Number of events 1 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.	0.00% 0/32 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.	0.00% 0/15 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.
Musculoskeletal and connective tissue disorders Isthmic Spondylolisthesis	0.00% 0/34 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.	0.00% 0/32 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.	6.7% 1/15 • Number of events 1 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.

Other adverse events

Other adverse events
Measure	Remote High n=34 participants at risk 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.	Remote Low n=32 participants at risk 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.	Personal Coach n=15 participants at risk Personal Coach: Participants will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education.
Musculoskeletal and connective tissue disorders Ankle Injury	8.8% 3/34 • Number of events 3 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.	3.1% 1/32 • Number of events 1 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.	13.3% 2/15 • Number of events 2 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.
Infections and infestations COVID-19 Infection	5.9% 2/34 • Number of events 2 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.	0.00% 0/32 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.	0.00% 0/15 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.
Gastrointestinal disorders Abdominal pain	5.9% 2/34 • Number of events 2 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.	0.00% 0/32 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.	0.00% 0/15 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/34 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.	0.00% 0/32 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.	6.7% 1/15 • Number of events 1 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.
Gastrointestinal disorders Gastritis and gastroparesis	0.00% 0/34 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.	0.00% 0/32 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.	6.7% 1/15 • Number of events 1 • 1 year Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.

Additional Information

Dr. Lauren Ptomey

University of Kansas Medical Center

Phone: 913-588-7983

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place