STEPS-PD: Support for Physical Activity in Everyday Life With Parkinson's Disease
Study Details
Study Description
Brief Summary
This study aims to determine the effects of a motor-cognitive exercise intervention, delivered in the home environment using eHealth methods, among people with Parkinson's disease. The intervention will support and motivate motor training, combined with cognitive training, aimed at attentional and executive functions, among people at mild-moderate disease stages. The main hypothesis is that unsupervised motor-cognitive training in the home environment using eHealth will lead to improvements in gait performance, increased physical activity levels and improved perceived health.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This randomised controlled trial will investigate the efficacy of a motor-cognitive exercise program in the home environment, over a 10-week period, on physical function, and motor-cognitive dual task function as well as physical activity behavior in everyday life. Participants will be recruited through Stockholms sjukhem foundation, Karolinska University and via announcements in relevant forums like for instance the Swedish Parkinson Association. Consenting participants will be randomized to the eHealth Intervention group or the control group condition. Block randomization will be achieved using a computerized random sequence generator. Blinded assessors will perform the pre- and post-intervention testing of physical performance.
The ultimate aim of this project is to provide people with PD with continual long-term and evidence-based rehabilitation in their everyday lives using mobile health technology, to support their self- management and increase their quality of life.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Motor-cognitive exercise using eHealth 10-week eHealth based motor-cognitive home training using digital tablets. Cognitive behavioural strategies to promote increase in physical activity levels (walking). Participants will be encouraged to perform 150 minutes of home exercise per week, occurring on three non-consecutive days. |
Behavioral: Motor-cognitive home exercise supported by eHealth technology
10-week, individualized and progressive exercise program targeting functional strength, cardiovascular fitness and physical activity levels. Cognitive exercises are incorporated with motor exercises as an adjunct to the intervention.
|
| Active Comparator: Individualised home training program Participants will receive an individualized home exercise program on paper and one instructional session. They will receive written instructions on performing the program 2-3 times weekly and instructions on exercise progression. They will receive no support during the 10-week period. |
Behavioral: Individualized home exercise program
Individualised home exercise program leaflet involving one initial instruction session. Written instructions involving dose and exercise progression. No support during the 10 week period.
|
Outcome Measures
Primary Outcome Measures
- The six minute walk test [Change in balance performance at 10 weeks]
This test measures walking capacity by measuring the distance covered (meters) over a time period of 6 minutes.
Secondary Outcome Measures
- Gait parameters during single and dual-task conditions [Change at 10 weeks]
Stride length (meters); Cadence (steps/ minute) will be captured using born-worn inertial sensors
- Quality of life questionnaires [Change at 10 weeks]
PDQ-39 is disease specific quality of life questionnaire. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100
- Physical activity measured with accelerometers [Change at 10 weeks]
Steps per day and time (minutes) in different physical activity intensities (high,moderate and low intensity)
- Dual-task ability during walking [Change at 10 weeks]
Captured using the Auditory Stroop test during walking and expressed as percentage error of the task
- Balance ability [Change at 10 weeks]
MiniBest test. Scoring 0-27, higher scores = greater balance impairment
- Executive function [Change at 10 weeks]
Trail making test A & B. Expressed as time required to perform the test (seconds)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of idiopathic Parkinson´s disease
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Hoehn & Yahr (Parkinsons progression scale) 2-3
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≥ 50 years of age
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Able to ambulate indoors without mobility aid
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Able to walk continually with/without a walking aid for at least 6 minutes
Exclusion Criteria:
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Cognitive impairment affecting the ability to understand or follow verbal or written instructions (Montreal Cognitive Assessment ≤ 21 points
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Major problems with freezing and/or two or more falls in the month previous to inclusion
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Other existing neurological/ orthopedic or cardiovascular disease which impedes the performance of unsupervised exercise
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Impaired vision and/or impaired communication which hinders participation
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No internet connection in the home
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Stiftelsen Stockholms Sjukhem
- Karolinska Institutet
Investigators
- Study Chair: Maria Ankarcrona, PhD, Karolinska Institutet, NVS
- Study Chair: Alexis Wärmländer, MD, Stockholms Sjukhem Foundation, Primary Care Rehabilitation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- StockholmsSjukhem