Walking Capacity in Parkinson's Disease (PD-Walk)

Idiopathic Parkinson's Disease Clinical Trial

Official title:

Does Home-based Treadmill Training Improve Walking Capacity and Quality of Life in People With Early to Mid-stage Parkinson's Disease?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00261781
• Other study ID #: U3189
• Status: Terminated
• Phase: N/A
• First received: December 1, 2005
• Last updated: May 27, 2015
• Start date: May 2005
• Est. completion date: September 2012

Study information

• Verified date: May 2015
• Source: University of Sydney
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: September 2012
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease

Intervention

Behavioral:
• Treadmill training
Walking on a treadmill 3 times per week for 6 weeks

Locations

Country	Name	City	State
Australia	Westmead Hospital	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Natalie Allen	South West Sydney Local Health District

Country where clinical trial is conducted

Australia, 

References & Publications (4)

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. — View Citation

Canning 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. — View Citation

Canning 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. — View Citation

Playfer JR. Falls and Parkinson's disease. Age Ageing. 2001 Jan;30(1):3-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance walked in 6 minutes		study entry (0 weeks), 7 and 13 weeks	No
Secondary	Unified Parkinson's disease Rating Scale (UPDRS) - motor examination		0, 7 and 13 weeks	No
Secondary	The Parkinson's disease Questionnaire (PDQ-39		0, 7 and 13 weeks	No
Secondary	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.		0, 7 and 13 weeks	No
Secondary	Walking consistency determined as the co-efficients of variation for stride time and stride length recorded during the 6 minute walk test.		0, 7 and 13 weeks	No