Brain Networks and Mobility Function: B-NET (B-NET)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03430427|
Recruitment Status : Not yet recruiting
First Posted : February 12, 2018
Last Update Posted : April 27, 2018
|Condition or disease|
|Central Nervous System White Matter Disease|
|Study Type :||Observational|
|Estimated Enrollment :||240 participants|
|Official Title:||Brain Networks and Mobility Function: B-NET|
|Estimated Study Start Date :||May 2018|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Community-Dwelling Older Adults
The group will consist of 240 community-dwelling older adults with a range of mobility function based on the short physical performance battery (SPPB).
- Change in Extended Short Physical Performance Battery (eSPPB) [ Time Frame: baseline and 6, 18, and 30 months ]The expanded Short Physical Performance Battery (eSPPB) is a modified version of a widely used assessment of lower extremity physical function that consists of 3 standing balance tasks held for 10 seconds each (side-by-side, tandem and semi-tandem), two 4-m walk tests to assess usual gait speed, and 5 repeated chair stands. To minimize ceiling effects and maximize overall dispersion of test scores, the eSPPB increases the holding time of the semi- and full-tandem stands to 30 seconds and adds a single leg stand and a narrow walk test of balance (walking at usual pace within lines of tape spaced 20 cm apart). eSPPB scores are continuous and range from 0 to 4, with higher scores indicative of better performance.
- Change in Cardiovascular fitness [ Time Frame: baseline and 18 and 30 months ]The fast-paced 400M walk protocol will be used.
- Change in Digit Symbol Substitution Test (DSST) [ Time Frame: baseline and 18 and 30 months ]The WAIS-III Digit Symbol Substitution Test will be used.
- Change in Gait Speed [ Time Frame: baseline and 18 and 30 months ]This will be assessed over 4 meters 3 times at usual pace and 3 times at fast pace using an instrumented mat (GAITRite System), which provides data on average step and stride length, initial and terminal double support time, as well as the variability in these measures
- Change in lower extremity muscle strength [ Time Frame: baseline and 18 and 30 months ]Maximal isokinetic knee extension and flexion strength will be measured using an isokinetic dynamometer
- Change in postural sway [ Time Frame: baseline and 18 and 30 months ]Postural sway during quiet stance will be assessed from Center-of-Pressure (COP) trajectory data collected at 100 Hz using an Advanced Mechanical Technology Incorporated (AMTI) AccuSway biomechanics force platform.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430427
|Contact: Stephen Kritchevsky, PhDfirstname.lastname@example.org|
|Contact: Kimberly Kennedyemail@example.com|
|United States, North Carolina|
|Wake Forest Baptist Medical Center||Not yet recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Stephen Kritchevsky, Ph.D. 336-713-8987 firstname.lastname@example.org|
|Contact: Kimberly Kennedy 336-713-8567 email@example.com|
|Sub-Investigator: Paul Laurienti, MD|
|Sub-Investigator: Laura Baker, PhD|
|Sub-Investigator: Jonathan Burdette, MD|
|Sub-Investigator: Michael Cartwright, MD|
|Sub-Investigator: Jasmin Divers, PhD|
|Sub-Investigator: Christina Hugenschmidt, PhD|
|Sub-Investigator: Michael Miller, PhD|
|Principal Investigator:||Stephen Kritchevsky, PhD||Wake Forest University Health Sciences|