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NCT03972969

Highly Challenging Balance Program to Reduce Fall Rate in PD

Completed NA Results posted Last updated 21 June 2024
What this trial tests

NA trial testing Facility-based structured exercise in Parkinson's Disease in 162 participants. Completed in 31 July 2023.

Timeline
1 October 2019
Primary endpoint
28 February 2023
31 July 2023

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeother
Enrollment162
Start date1 October 2019
Primary completion28 February 2023
Estimated completion31 July 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 40 to 89, 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.

Number of Falls Over 3 Month Period Primary · Baseline to 3 months

Total number of falls from baseline to the 3-month follow-up. Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level.

GroupValue95% CI
In-person Exercise Group1.1± 2.7
Remote Exercise Group1.6± 3.0
Control Group9.7± 48.4
Number of Falls Over 6 Month Period Secondary · Baseline to 6 months

Total number of falls from baseline to the 6-month follow-up. Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level.

GroupValue95% CI
In-person Exercise Group2.08± 3.46
Remote Exercise Group3.02± 6.32
Control Group11.36± 49.55

Sponsor's own description

This study will test the hypothesis that two highly challenging exercise programs, one based at the VA medical center and the other conducted remotely, will both significantly reduce overall fall rates in patients with Parkinson's disease.

Publications & conference data

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

  1. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis.
    Ernst M, Folkerts AK, Gollan R, Lieker E, et al · · 2023 · cited 110× · PMID 36602886 · DOI 10.1002/14651858.cd013856.pub2
  2. Interventions for preventing falls in Parkinson's disease.
    Allen NE, Canning CG, Almeida LRS, Bloem BR, et al · · 2022 · cited 50× · PMID 35665915 · DOI 10.1002/14651858.cd011574.pub2
  3. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis.
    Ernst M, Folkerts AK, Gollan R, Lieker E, et al · · 2024 · cited 37× · PMID 38588457 · DOI 10.1002/14651858.cd013856.pub3

Verify or expand the search:

Other recruiting trials for Parkinson's Disease

Currently open trials in the same condition.

Other VA Office of Research and Development trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03972969.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing