NCT03542474

Mild Cognitive Impairment and Endurance Exercise in Parkinson's Disease

Completed NA Results posted Last updated 14 July 2020

What this trial tests

NA trial testing High Intensity Endurance Exercise in Parkinson Disease in 8 participants. Completed in 31 August 2019.

Timeline

15 May 2017

Primary endpoint
5 November 2018

31 August 2019

Quick facts

Lead sponsor	Northwestern University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	15 May 2017
Primary completion	5 November 2018
Estimated completion	31 August 2019
Sites	1 location across United States

Drugs / interventions tested

• High Intensity Endurance Exercise

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →
• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →

Sponsor

Northwestern University

Who can join

Adults 40 to 85, any sex, with Parkinson Disease or Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change in Cognitive Function Primary · Baseline and 6 Months

Mean change in cognitive function from baseline to 6-months as measured by global statistical test (GST) for cognitive domains. This will be a composite score reported as Z-scores. The Z-score indicates the number of standard deviations away from the mean, which is based on normative (healthy control) data. A Z-score of 0 is equal to the mean of the normative data with negative numbers indicating values lower than the mean and positive values higher. A positive change in Z-scores indicates a favorable outcome. The GSTs will be calculated from the following neuropsychological tests administere

GST-Global Pre

Group	Value	95% CI
Exercise	-0.6960	± 0.6691

GST-Global Post

Group	Value	95% CI
Exercise	-0.6095	± 0.7506

GST-Attention/Working Memory Pre

Group	Value	95% CI
Exercise	0.6018	± 0.4147

GST-Attention/Working Memory Post

Group	Value	95% CI
Exercise	0.6018	± 0.4548

GST-Executive Function Pre

Group	Value	95% CI
Exercise	-1.657	± 1.199

GST-Executive Function Post

Group	Value	95% CI
Exercise	-1.462	± 1.240

GST-Memory Pre

Group	Value	95% CI
Exercise	-1.269	± 0.7684

GST-Memory Post

Group	Value	95% CI
Exercise	-1.196	± 0.7054

6 Month Change in Salivary Cortisol Levels Secondary · Baseline and 6 Months

Change in salivary cortisol levels between baseline and 6 months post exercise. Cortisol samples were taken before the exercise intervention (Pre) and after the exercise intervention (Post) at 8 different time points: At awakening (0), 15 minutes post awakening (0.25), 30 minutes post awakening (0.5), 45 minutes post awakening (0.75), 3 hours post awakening (3), 6 hours post awakening (6), 9 hours post awakening (9), and 12 hours post awakening (12).

0 Pre

Group	Value	95% CI
Exercise	13.064	± 2.1

0 Post

Group	Value	95% CI
Exercise	10.486	± 1

0.25 Pre

Group	Value	95% CI
Exercise	18.996	± 2.6

0.25 Post

Group	Value	95% CI
Exercise	15.568	± 1.5

0.5 Pre

Group	Value	95% CI
Exercise	18.196	± 2.2

0.5 Post

Group	Value	95% CI
Exercise	16.29	± 1.9

0.75 Pre

Group	Value	95% CI
Exercise	19.34	± 2.6

0.75 Post

Group	Value	95% CI
Exercise	14.247	± 1.4

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Exercise

Serious: 0/8 (0%)

Deaths: 0/8

Other adverse events (4 terms — click to expand)

Reaction	System	Exercise
Fall	Injury, poisoning and procedural complications	—
Back pain	Injury, poisoning and procedural complications	—
Outpatient surgery	Surgical and medical procedures	—
Hip Pain	Injury, poisoning and procedural complications	—

Data from ClinicalTrials.gov NCT03542474 adverse events section.

Sponsor's own description

The overall objective of this study is to determine how high intensity endurance exercise affects both cognition and the signs and symptoms of Parkinson's disease as well as if certain brain structures and functions also change with this exercise.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.