NCT01014663

Brief Summary

The primary purpose of this study is to compare the effects of a non-traditional boxing training program to a traditional therapeutic exercise program on activity and participation outcomes in persons with Parkinson's disease. Thirty participants will be randomly assigned to participate in either non-contact boxing training or traditional therapeutic exercise for 36 sessions over 12 weeks. Participants will be measured immediately before (pre-test) and after (post-test) the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

April 2, 2020

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

November 13, 2009

Last Update Submit

March 31, 2020

Conditions

Keywords

Parkinson's diseaseexercisetraining programrehabilitationboxing

Outcome Measures

Primary Outcomes (1)

  • Mobility: Measured with the Timed Up and Go Test; Four-Square Step Test; Six-Minute Walk Test; Berg Balance Scale; Functional Reach Test

    Each outcome measures is assessed at pre-test (immediately before intervention), post-test (immediately after the 12 week intervention).

Secondary Outcomes (1)

  • Participation: measured with the Activities Specific Balance Confidence Scale and the Parkinson's disease Quality of Life Scale

    Each outcome measures is assessed at pre-test (immediately before intervention), post-test (immediately after the 12 week intervention).

Study Arms (2)

Therapeutic Exercise

ACTIVE COMPARATOR
Behavioral: Traditional Therapeutic Exercise

Non-Contact Boxing Training

ACTIVE COMPARATOR
Behavioral: Non-Contact Boxing Training

Interventions

The therapeutic exercise program will consist of warm-up and stretching, seated and standing range of motion activities, endurance and resistance training, balance training and a cool down. Training will take place for 36 sessions, three times/week for 60-90 minutes per session.

Therapeutic Exercise

Non-contact boxing training will consist of warm-up and stretching, non-contact boxing training (including punching a focus mitt, speed and heavy punching bags), endurance training activities, strength and resistance training, and a cool down. Training will take place for 36 sessions, three times/week for 60-90 minutes per session.

Non-Contact Boxing Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of Parkinson's disease
  • currently not receiving physical therapy services
  • medically stable with a physician release stating approval to enter an exercise program
  • independently ambulatory in the home setting with or without the use of an assistive device
  • able to follow at least three step verbal commands
  • available for the entire period of the study
  • have transportation to and from training and measurement sessions

You may not qualify if:

  • preexisting neurological conditions other than Parkinson's disease
  • current musculoskeletal conditions that would limit participation in either training program
  • significant orthopedic surgery within the past six months
  • past brain surgery or brain stimulator implant
  • currently known pregnant
  • pre-existing cardiovascular conditioner that would prohibit participation in an exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Indianapolis, Krannert School of Physical Therapy

Indianapolis, Indiana, 46227, United States

Location

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 DiseaseMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Stephanie A Combs, PT, PhD, NCS

    University of Indianapolis

    PRINCIPAL INVESTIGATOR
  • Dyer M Diehl, PT, PhD

    University of Indianapolis

    PRINCIPAL INVESTIGATOR
  • William H Staples, PT, DPT, GCS

    University of Indianapolis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 13, 2009

First Posted

November 17, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2010

Study Completion

March 1, 2011

Last Updated

April 2, 2020

Record last verified: 2020-03

Locations