Idiopathic Parkinson's DiseaseNCT00261781
Walking Capacity in Parkinson's Disease (PD-Walk)
A study testing Treadmill training in people with Idiopathic Parkinson's Disease, run by Natalie Allen at 1 site in Australia.
Trial summary
The major aim of this study is to determine the efficacy of a home-based treadmill walking program in improving walking capacity and quality of life in people with early mid-stage Parkinson's disease(PD). Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Idiopathic Parkinson's Disease
- What is being tested?
- Treadmill training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- May 2005to Sep 2012
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of idiopathic Parkinson's disease
- aged 30-80 years old
- subjective disturbance of gait and / or Unified Parkinson's disease rating scale (UPDRS) gait subscore of 1
- sedentary, defined as performing less than 2 hours / week of leisure-time physical activity over the prior 3 months
- have adapted to their current anti-Parkinsonian medication for at least 2 weeks
Who cannot join
- motor fluctuations or dyskinesias which are disabling
- require the use of a walking aid
- more than one fall in the last 12 months
- Mini-Mental State Examination score of <24
- exhibit other neurological or musculoskeletal conditions affecting walking
- chest pain at rest or during exercise in the last 3 months, or heart attack, angioplasty or heart surgery in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Home-based Treadmill Training Improve Walking Capacity and Quality of Life in People With Early to Mid-stage Parkinson's Disease?
The major aim of this study is to determine the efficacy of a home-based treadmill walking program in improving walking capacity and quality of life in people with early mid-stage Parkinson's disease(PD).
Read the detailed description
After Alzheimer's disease, Parkinson's disease (PD) is the most common degenerative neurological condition suffered by Australians, with more than 30,000 Australians having PD at any one time (Parkinson's Australia). Hypokinesia, ie, reduced speed and amplitude of movement, is a major impairment of motor control affecting walking in people with PD. Over time, the development of slow, shuffling walking contributes to loss of independence and falls, with devastating consequences for individuals with PD and their families(Ashburn et al, 2001, Playfer 2001). Any decrease or delay in disability will reduce the personal and financial costs to individuals with PD, their families, health care resources and the community.
A number of previous studies suggest exercise capacity and exercise habits are positively correlated. In people with mild Parkinson's disease (Canning et al 2005), walking capacity, measured as distance walked in the 6-min walk test, correlated with the amount of walking (r=.64, p<0.01) performed each week. Similarly, in an earlier study of people with mild to moderate Parkinson's disease, regular exercise was associated with better exercise capacity (Canning et al 1997). It appears, therefore, that proactive intervention aimed at developing good exercise habits in sedentary individuals with early to mid-stage Parkinson's disease has the potential to reduce or delay walking difficulties.
This study aims to establish the efficacy of a home-based treadmill walking program in providing an early intervention which addresses the primary motor control impairment of hypokinesia, while at the same time maintaining or improving exercise capacity.
- Conditions
- Idiopathic Parkinson's Disease
- Being tested
- Treadmill training
- Keywords
- Treadmill, Walking, Exercise, Automaticity, Quality of Life
- 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.
Treadmill trainingBehavioural
Walking on a treadmill 3 times per week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treadmill training | Experimental | Home-based treadmill training Receives: Behavioral: Treadmill training |
| Usual care | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance walked in 6 minutes
Measured: study entry (0 weeks), 7 and 13 weeks
Secondary outcomes (4)
Unified Parkinson's disease Rating Scale (UPDRS) - motor examination
Measured: 0, 7 and 13 weeks
The Parkinson's disease Questionnaire (PDQ-39
Measured: 0, 7 and 13 weeks
Walking Automaticity, determined as the velocity of walking 10m while performing a concurrent (cognitive or cognitive + physical) task expressed as a percentage of the velocity of walking 10m without performing the concurrent task.
Measured: 0, 7 and 13 weeks
Walking consistency determined as the co-efficients of variation for stride time and stride length recorded during the 6 minute walk test.
Measured: 0, 7 and 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2005 (estimated)
- Study startMay 2005
- Primary completionDec 2006
- Study completionSep 2012
Why it stopped: 20 subjects completed for a pilot, further funding required to continue study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Idiopathic 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natalie Allen
- Sponsor type
- University, hospital or other
- Collaborators
- South West Sydney Local Health District
- Responsible party
- Sponsor-investigator, Natalie Allen, University of Sydney
- Investigators
- Colleen G Canning, PhD, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261781
- Sponsor's protocol ID
- U3189
- Status last verified
- May 2015
- First submitted
- 1 Dec 2005
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ashburn A, Stack E, Pickering RM, Ward CD. A community-dwelling sample of people with Parkinson's disease: characteristics of fallers and non-fallers. Age Ageing. 2001 Jan;30(1):47-52. doi: 10.1093/ageing/30.1.47.
PubMed 11322672Canning CG, Alison JA, Allen NE, Groeller H. Parkinson's disease: an investigation of exercise capacity, respiratory function, and gait. Arch Phys Med Rehabil. 1997 Feb;78(2):199-207. doi: 10.1016/s0003-9993(97)90264-1.
PubMed 9041903Playfer JR. Falls and Parkinson's disease. Age Ageing. 2001 Jan;30(1):3-4. doi: 10.1093/ageing/30.1.3. No abstract available.
PubMed 11322669Canning CG, Allen NE, Dean CM, Goh L, Fung VS. Home-based treadmill training for individuals with Parkinson's disease: a randomized controlled pilot trial. Clin Rehabil. 2012 Sep;26(9):817-26. doi: 10.1177/0269215511432652. Epub 2012 Jan 18.
PubMed 22257506
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Home-based Treadmill Training Improve Walking Capacity and Quality of Life in People With Early to Mid-stage Parkinson's Disease?
- ClinicalTrials.gov ID
- NCT00261781
- Acronym / sponsor ID
- U3189
- Conditions
- Idiopathic Parkinson's Disease
- Keywords
- Treadmill, Walking, Exercise, Automaticity, Quality of Life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 20 subjects completed for a pilot, further funding required to continue study
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Natalie AllenUniversity, hospital or other
- Collaborators
- South West Sydney Local Health District
- Study start
- May 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 5 Dec 2005 (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 major aim of this study is to determine the efficacy of a home-based treadmill walking program in improving walking capacity and quality of life in people with early mid-stage Parkinson's disease(PD).
Detailed description
After Alzheimer's disease, Parkinson's disease (PD) is the most common degenerative neurological condition suffered by Australians, with more than 30,000 Australians having PD at any one time (Parkinson's Australia). Hypokinesia, ie, reduced speed and amplitude of movement, is a major impairment of motor control affecting walking in people with PD. Over time, the development of slow, shuffling walking contributes to loss of independence and falls, with devastating consequences for individuals with PD and their families(Ashburn et al, 2001, Playfer 2001). Any decrease or delay in disability will reduce the personal and financial costs to individuals with PD, their families, health care resources and the community.
A number of previous studies suggest exercise capacity and exercise habits are positively correlated. In people with mild Parkinson's disease (Canning et al 2005), walking capacity, measured as distance walked in the 6-min walk test, correlated with the amount of walking (r=.64, p<0.01) performed each week. Similarly, in an earlier study of people with mild to moderate Parkinson's disease, regular exercise was associated with better exercise capacity (Canning et al 1997). It appears, therefore, that proactive intervention aimed at developing good exercise habits in sedentary individuals with early to mid-stage Parkinson's disease has the potential to reduce or delay walking difficulties.
This study aims to establish the efficacy of a home-based treadmill walking program in providing an early intervention which addresses the primary motor control impairment of hypokinesia, while at the same time maintaining or improving exercise capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill training | Experimental | Behavioral: Treadmill trainingHome-based treadmill training |
| Usual care | No intervention | –Control group |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- clinical diagnosis of idiopathic Parkinson's disease
- aged 30-80 years old
- subjective disturbance of gait and / or Unified Parkinson's disease rating scale (UPDRS) gait subscore of 1
- sedentary, defined as performing less than 2 hours / week of leisure-time physical activity over the prior 3 months
- have adapted to their current anti-Parkinsonian medication for at least 2 weeks
Key exclusion criteria (6 listed)
- motor fluctuations or dyskinesias which are disabling
- require the use of a walking aid
- more than one fall in the last 12 months
- Mini-Mental State Examination score of <24
- exhibit other neurological or musculoskeletal conditions affecting walking
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 |
|---|---|---|
| Treadmill trainingWalking on a treadmill 3 times per week for 6 weeks | Behavioural | Treadmill training |
Primary outcome
Distance walked in 6 minutes
Time frame: study entry (0 weeks), 7 and 13 weeks
4 secondary outcomes
Unified Parkinson's disease Rating Scale (UPDRS) - motor examination
Time frame: 0, 7 and 13 weeks
The Parkinson's disease Questionnaire (PDQ-39
Time frame: 0, 7 and 13 weeks
Walking Automaticity, determined as the velocity of walking 10m while performing a concurrent (cognitive or cognitive + physical) task expressed as a percentage of the velocity of walking 10m without performing the concurrent task.
Time frame: 0, 7 and 13 weeks
Walking consistency determined as the co-efficients of variation for stride time and stride length recorded during the 6 minute walk test.
Time frame: 0, 7 and 13 weeks
Results and safety
The study was stopped early (reason given: 20 subjects completed for a pilot, further funding required to continue study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
- Background: PubMed 11322672Ashburn A, Stack E, Pickering RM, Ward CD. A community-dwelling sample of people with Parkinson's disease: characteristics of fallers and non-fallers. Age Ageing. 2001 Jan;30(1):47-52. doi: 10.1093/ageing/30.1.47.
- Background: PubMed 9041903Canning CG, Alison JA, Allen NE, Groeller H. Parkinson's disease: an investigation of exercise capacity, respiratory function, and gait. Arch Phys Med Rehabil. 1997 Feb;78(2):199-207. doi: 10.1016/s0003-9993(97)90264-1.
- Background: PubMed 11322669Playfer JR. Falls and Parkinson's disease. Age Ageing. 2001 Jan;30(1):3-4. doi: 10.1093/ageing/30.1.3. No abstract available.
- Results publication: PubMed 22257506Canning CG, Allen NE, Dean CM, Goh L, Fung VS. Home-based treadmill training for individuals with Parkinson's disease: a randomized controlled pilot trial. Clin Rehabil. 2012 Sep;26(9):817-26. doi: 10.1177/0269215511432652. Epub 2012 Jan 18.
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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.
Colleen G Canning, PhD principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill training in people with Idiopathic Parkinson's Disease, run by Natalie Allen at 1 site in Australia.
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 5 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: stopped early, as of the sponsor's last update on 29 May 2015. 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 Australia. 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 was stopped early (reason given: 20 subjects completed for a pilot, further funding required to continue study). Results are not available in the source record.
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?
Distance walked in 6 minutes (time frame: study entry (0 weeks), 7 and 13 weeks). 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 NCT00261781, which also lists 4 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 29 May 2015.