NCT03618901

Brief Summary

This study evaluates the effect on Rock Steady Boxing (RSB) and PD SAFEx on Parkinson's disease.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 30, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

May 16, 2019

Status Verified

May 1, 2019

Enrollment Period

10 months

First QC Date

July 18, 2018

Last Update Submit

May 14, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Motor symptom improvements

    Unified Parkinson Disease Rating Scale (UPDRS) conducted by a qualified movement disorders specialist. The maximum score is 108, the higher the score, the worse the symptoms.

    change from baseline at 12 weeks

Secondary Outcomes (8)

  • Quality of life assessments

    change from baseline at 12 weeks

  • Balance1

    change from baseline at 12 weeks

  • Gait1

    change from baseline at 12 weeks

  • Strength

    change from baseline at 12 weeks

  • Cognitive Assessment 1

    change from baseline at 12 weeks

  • +3 more secondary outcomes

Other Outcomes (3)

  • Balance3

    change from baseline at 12 weeks

  • Physical activity

    change from baseline at 12 weeks

  • Gait 2

    change from baseline at 12 weeks

Study Arms (2)

Rock Steady Boxing

EXPERIMENTAL

Non-contact boxing program.

Other: Rock Steady Boxing

PD SAFEx

ACTIVE COMPARATOR

Sensory attention focused exercise.

Other: PD SAFEx

Interventions

Boxing programs as offered by the Rock Steady Boxing institution,

Rock Steady Boxing

Progressive proprioception training.

PD SAFEx

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • must be able to understand verbal instructions in English
  • diagnosed with idiopathic PD by a neurologist

You may not qualify if:

  • if diagnosed with a neurological condition other than PD
  • if participated in an exercise program at least 2-weeks prior to the start of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Movement Disorders Research and Rehabilitation Centre

Waterloo, Ontario, N2L 3J4, Canada

RECRUITING

Related Publications (2)

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The early start group: 12-weeks (intervention) followed by 12-weeks of no exercise. The delayed start group: 12-weeks (no exercise) followed by 12-weeks (intervention). This model will be used for both RSB and PD SAFEx.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

July 18, 2018

First Posted

August 7, 2018

Study Start

September 30, 2018

Primary Completion

July 30, 2019

Study Completion

August 30, 2019

Last Updated

May 16, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations