NCT02248649

Telemedicine Intervention to Improve Cognitive Function

Completed NA Results posted Last updated 24 July 2019

What this trial tests

NA trial testing Structured physical activity in Parkinson's Disease in 160 participants. Completed in 30 September 2018.

Timeline

1 December 2014

Primary endpoint
15 May 2018

30 September 2018

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	160
Start date	1 December 2014
Primary completion	15 May 2018
Estimated completion	30 September 2018
Sites	1 location across United States

Drugs / interventions tested

• Structured physical activity
• Health education

Conditions studied

• Parkinson's Disease — all drugs for Parkinson's Disease →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

40 and older, any sex, with Parkinson's Disease. 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.

Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 6 Primary · Baseline and 6 months

The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 6-month - Score at Baseline.

Group	Value	95% CI
Physical Activity	-0.24	± 0.62
Control	0.95	± 0.78

Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 12 Secondary · Baseline and 12 months

The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 12-month - Score at Baseline.

Group	Value	95% CI
Physical Activity	0.12	± 0.79
Control	2.60	± 0.91

Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 18 Secondary · Baseline and 18 month

The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 12-month - Score at Baseline.

Group	Value	95% CI
Physical Activity	0.40	± 0.99
Control	3.60	± 1.03

Adverse events — posted to ClinicalTrials.gov

Time frame: 18 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Physical Activity

Serious: 7/80 (9%)

Deaths: 7/80

Control

Serious: 11/80 (14%)

Deaths: 11/80

Serious adverse events (1 terms)

Reaction	System	Physical Activity	Control
Death	General disorders	—	—

Most-reported serious reactions: Death.

Data from ClinicalTrials.gov NCT02248649 adverse events section.

Sponsor's own description

This project is investigating whether a home-based exercise program will reduce cognitive decline in patients with Parkinson's disease.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Treatment of Parkinson's Disease with Cognitive Impairment: Current Approaches and Future Directions.
   Sun C, Armstrong MJ. · · 2021 · cited 50× · PMID 33920698 · DOI 10.3390/bs11040054
2. Telemedicine and the assessment of clinician time: a scoping review.
   Kidholm K, Jensen LK, Johansson M, Montori VM. · · 2023 · cited 16× · PMID 38099431 · DOI 10.1017/s0266462323002830