Parkinson's DiseaseNCT01014663
Non-contact Boxing Training and Traditional Therapeutic Exercise for Persons With Parkinson's Disease
A study testing Traditional Therapeutic Exercise and Non-Contact Boxing Training in people with Parkinson's Disease, run by University of Indianapolis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Traditional Therapeutic Exercise and Non-Contact Boxing Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Indianapolis, Krannert School of Physical Therapy
Indianapolis, Indiana, 46227
About this study
Official title: Comparison of Non-contact Boxing Training and Traditional Therapeutic Exercise on Functional Outcomes in Persons With Parkinson's Disease
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.
Read the detailed description
Physical therapists commonly treat patients with Parkinson's disease. Typical clinical interventions used by physical therapists including strengthening, stretching and aerobic training have been shown to improve function and quality of life of persons with Parkinson's disease. Alternative exercise interventions that incorporate non-traditional concepts, such as tango dance, tai chi and taiji have also been found to lead to improvements in function in persons with Parkinson's disease. It is important that comparisons between different types of exercise programs for persons with Parkinson's disease be explored in order to determine effective options for care.
Here in Indianapolis, Indiana, individuals with Parkinson's disease have a unique opportunity for alternative exercise with the recent development of the popular non-contact boxing training program offered by the Rock Steady Boxing Foundation. Therefore, the purpose of this study is to compare the effects of the non-traditional boxing training program to a traditional therapeutic exercise program on activity and participation outcomes in persons with Parkinson's disease.
Thirty participants with Parkinson's disease will be recruited from Central Indiana. All potential participants will be screened to determine eligibility for the study. Participants who are eligible and give consent will be randomly assigned to participate in either the non-contact boxing training or the traditional therapeutic exercise program for 36 sessions lasting over 12 weeks with 60-90 minutes of exercise each session. Participants will be measured immediately before (pre-test) and after (post-test) the intervention period.
- Conditions
- Parkinson's Disease
- Being tested
- Traditional Therapeutic Exercise, Non-Contact Boxing Training
- Keywords
- Parkinson's disease, exercise, training program, rehabilitation, boxing
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Therapeutic ExerciseBehavioural
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.
Non-Contact Boxing TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Exercise | Active comparator | Not described Receives: Behavioral: Traditional Therapeutic Exercise |
| Non-Contact Boxing Training | Active comparator | Not described Receives: Behavioral: Non-Contact Boxing Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility: Measured with the Timed Up and Go Test; Four-Square Step Test; Six-Minute Walk Test; Berg Balance Scale; Functional Reach Test
Measured: 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
Measured: Each outcome measures is assessed at pre-test (immediately before intervention), post-test (immediately after the 12 week intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Indianapolis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Miller, University of Indianapolis
- Investigators
- Stephanie A Combs, PT, PhD, NCS, Principal investigator, University of IndianapolisDyer M Diehl, PT, PhD, Principal investigator, University of IndianapolisWilliam H Staples, PT, DPT, GCS, Principal investigator, University of Indianapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014663
- Sponsor's protocol ID
- EXB-01
- Status last verified
- Mar 2020
- First submitted
- 13 Nov 2009
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38588457Ernst 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.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Non-contact Boxing Training and Traditional Therapeutic Exercise on Functional Outcomes in Persons With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01014663
- Acronym / sponsor ID
- EXB-01
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, exercise, training program, rehabilitation, boxing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of IndianapolisUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 17 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Physical therapists commonly treat patients with Parkinson's disease. Typical clinical interventions used by physical therapists including strengthening, stretching and aerobic training have been shown to improve function and quality of life of persons with Parkinson's disease. Alternative exercise interventions that incorporate non-traditional concepts, such as tango dance, tai chi and taiji have also been found to lead to improvements in function in persons with Parkinson's disease. It is important that comparisons between different types of exercise programs for persons with Parkinson's disease be explored in order to determine effective options for care.
Here in Indianapolis, Indiana, individuals with Parkinson's disease have a unique opportunity for alternative exercise with the recent development of the popular non-contact boxing training program offered by the Rock Steady Boxing Foundation. Therefore, the purpose of this study is to compare the effects of the non-traditional boxing training program to a traditional therapeutic exercise program on activity and participation outcomes in persons with Parkinson's disease.
Thirty participants with Parkinson's disease will be recruited from Central Indiana. All potential participants will be screened to determine eligibility for the study. Participants who are eligible and give consent will be randomly assigned to participate in either the non-contact boxing training or the traditional therapeutic exercise program for 36 sessions lasting over 12 weeks with 60-90 minutes of exercise each session. Participants will be measured immediately before (pre-test) and after (post-test) the intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Exercise | Active comparator | Behavioral: Traditional Therapeutic Exercise |
| Non-Contact Boxing Training | Active comparator | Behavioral: Non-Contact Boxing Training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Therapeutic ExerciseThe 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. | Behavioural | Therapeutic Exercise |
| Non-Contact Boxing TrainingNon-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. | Behavioural | Non-Contact Boxing Training |
Primary outcome
Mobility: Measured with the Timed Up and Go Test; Four-Square Step Test; Six-Minute Walk Test; Berg Balance Scale; Functional Reach Test
Time frame: Each outcome measures is assessed at pre-test (immediately before intervention), post-test (immediately after the 12 week intervention).
1 secondary outcome
Participation: measured with the Activities Specific Balance Confidence Scale and the Parkinson's disease Quality of Life Scale
Time frame: Each outcome measures is assessed at pre-test (immediately before intervention), post-test (immediately after the 12 week intervention).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Derived from this study: PubMed 38588457Ernst 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.
- Derived from this study: PubMed 36602886Ernst 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie A Combs, PT, PhD, NCS principal investigator
University of Indianapolis
Dyer M Diehl, PT, PhD principal investigator
University of Indianapolis
William H Staples, PT, DPT, GCS principal investigator
University of Indianapolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Therapeutic Exercise and Non-Contact Boxing Training in people with Parkinson's Disease, run by University of Indianapolis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility: Measured with the Timed Up and Go Test; Four-Square Step Test; Six-Minute Walk Test; Berg Balance Scale; Functional Reach Test (time frame: Each outcome measures is assessed at pre-test (immediately before intervention), post-test (immediately after the 12 week intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01014663, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.