Trial Outcomes & Findings for Impact of Physical Activity on Cognitive Outcomes in Youth With Pediatric-Onset Multiple Sclerosis (POMS) (NCT NCT03933020)
NCT ID: NCT03933020
Last Updated: 2022-05-19
Results Overview
A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.
TERMINATED
NA
2 participants
3 months
2022-05-19
Participant Flow
The 2 enrolled participants were lost to follow up before they were assigned to an intervention; therefore, no participants "started" per the ClinicalTrials.gov definition of "started," which is "the number of participants assigned to each arm or group."
Participant milestones
| Measure |
All Participants
The enrolled participants were lost to follow up before being assigned to any intervention.
|
|---|---|
|
Overall Study
STARTED
|
0
|
|
Overall Study
Received an Intervention
|
0
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
After searching all records and contacting all team members, the age of one of the participants was not able to be determined.
Baseline characteristics by cohort
| Measure |
All Participants
n=2 Participants
The enrolled participants were lost to follow up before being assigned to any intervention.
|
|---|---|
|
Age, Continuous
|
19 years
STANDARD_DEVIATION 0 • n=1 Participants • After searching all records and contacting all team members, the age of one of the participants was not able to be determined.
|
|
Sex: Female, Male
Female
|
1 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=2 Participants
|
|
Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)
|
61 score on a scale
STANDARD_DEVIATION 2.8 • n=2 Participants
|
|
Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning test - II
|
61.5 score on a scale
STANDARD_DEVIATION 7.78 • n=2 Participants
|
|
Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT)
|
29 score on a scale
STANDARD_DEVIATION 4.2 • n=2 Participants
|
|
Anxiety and Depression and Indicated by Score on the Hospital Anxiety and Depression Scale (HADS)
|
11 score on a scale
STANDARD_DEVIATION 0 • n=1 Participants • Data for this outcome measure were collected from only 1 participant.
|
|
Physical and psychological impact of MS as assessed by the Multiple Sclerosis Impact Scale-29
|
108 score on a scale
STANDARD_DEVIATION 0 • n=1 Participants • Data for this outcome measure were only collected from 1 participant.
|
|
Fatigue as assessed by the Modified Fatigue Impact Scale (MFIS)
|
75 score on a scale
STANDARD_DEVIATION 0 • n=1 Participants • Data for this outcome measure were collected for only 1 participant.
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Data for this outcome measure were not collected from any participant.
A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 monthsPopulation: Data for this outcome measure were not collected from any participant.
A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 12 monthsPopulation: Data for this outcome measure were not collected from any participant.
A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 3 monthsPopulation: Data for this outcome measure were not collected from any participant.
A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 monthsPopulation: Data for this outcome measure were not collected from any participant.
A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 12 monthsPopulation: Data for this outcome measure were not collected from any participant.
A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 3 monthsPopulation: Data for this outcome measure were not collected from any participant.
A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 monthsPopulation: Data for this outcome measure were not collected from any participant.
A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 12 monthsPopulation: Data for this outcome measure were not collected from any participant.
A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 MonthPopulation: Data for this outcome measure were not collected from any participant.
29-item self-report measuring the physical and psychological impact of MS from the patient's perspective during the previous 2 weeks. The assessment consists of 29 statements, each scored between 1 (not at all) and 5 (extremely), with a total score between 29 and 145.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthPopulation: Data for this outcome measure were not collected from any participant.
29-item self-report measuring the physical and psychological impact of MS from the patient's perspective during the previous 2 weeks. The assessment consists of 29 statements, each scored between 1 (not at all) and 5 (extremely), with a total score between 29 and 145.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthPopulation: Data for this outcome measure were not collected from any participant.
29-item self-report measuring the physical and psychological impact of MS from the patient's perspective during the previous 2 weeks. The assessment consists of 29 statements, each scored between 1 (not at all) and 5 (extremely), with a total score between 29 and 145.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: Data for this outcome measure were not collected from any participant.
21-item self-report measuring the impact of fatigue on physical, cognitive and psychosocial aspects of MS during the previous 4 weeks. The assessment contains 21 statements, each scored between 0 (never) and 4 (almost always). Items can be aggregated into three subscales (physical, cognitive, and psychosocial) as well as into a total MFIS score. The physical subscale can range from 0 to 36. The cognitive subscale can range from 0 to 40. The psychosocial subscale can range from 0 to 8. The total MFIS score can range from 0 to 84.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthPopulation: Data for this outcome measure were not collected from any participant.
21-item self-report measuring the impact of fatigue on physical, cognitive and psychosocial aspects of MS during the previous 4 weeks. The assessment contains 21 statements, each scored between 0 (never) and 4 (almost always). Items can be aggregated into three subscales (physical, cognitive, and psychosocial) as well as into a total MFIS score. The physical subscale can range from 0 to 36. The cognitive subscale can range from 0 to 40. The psychosocial subscale can range from 0 to 8. The total MFIS score can range from 0 to 84.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthPopulation: Data for this outcome measure were not collected from any participant.
21-item self-report measuring the impact of fatigue on physical, cognitive and psychosocial aspects of MS during the previous 4 weeks. The assessment contains 21 statements, each scored between 0 (never) and 4 (almost always). Items can be aggregated into three subscales (physical, cognitive, and psychosocial) as well as into a total MFIS score. The physical subscale can range from 0 to 36. The cognitive subscale can range from 0 to 40. The psychosocial subscale can range from 0 to 8. The total MFIS score can range from 0 to 84.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthPopulation: Data for this outcome measure were not collected from any participant.
14-item self-report measuring the degree of anxiety and depression in participants during the previous week. The assessment contains 14 statements, each scored between 3 (most of the time) and 0 (not at all). The score can be subdivided into a Depression scale that can range from 0 to 21, and an Anxiety scale, that can range from 0 to 21.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthPopulation: Data for this outcome measure were not collected from any participant.
14-item self-report measuring the degree of anxiety and depression in participants during the previous week. The assessment contains 14 statements, each scored between 3 (most of the time) and 0 (not at all). The score can be subdivided into a Depression scale that can range from 0 to 21, and an Anxiety scale, that can range from 0 to 21.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthPopulation: Data for this outcome measure were not collected from any participant.
14-item self-report measuring the degree of anxiety and depression in participants during the previous week. The assessment contains 14 statements, each scored between 3 (most of the time) and 0 (not at all). The score can be subdivided into a Depression scale that can range from 0 to 21, and an Anxiety scale, that can range from 0 to 21.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data for this outcome measure were not collected from any participant.
the participant is instructed to walk for six minutes as quickly and safely as possible and the distance covered will be recorded
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data for this outcome measure were not collected from any participant.
the participant is instructed to walk for six minutes as quickly and safely as possible and the distance covered will be recorded
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data for this outcome measure were not collected from any participant.
Assessment at each clinic visit
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data for this outcome measure were not collected from any participant.
Assessment at each MRI
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 monthPopulation: Data for this outcome measure were not collected from any participant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthPopulation: Data for this outcome measure were not collected from any participant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthPopulation: Data for this outcome measure were not collected from any participant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data for this outcome measure were not collected from any participant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data for this outcome measure were not collected from any participant.
Outcome measures
Outcome data not reported
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Rohini D. Samudralwar, MD
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place