eHealth, Gait Disorders, Neurologic, Parkinson Disease, Physical Activity
Conditions
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.
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. A follow-up assessment comprising health-related questionnaires and physical activity monitoring will be conducted at one year post-intervention. 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.
Interventions
BEHAVIORALMotor-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.
BEHAVIORALIndividualized 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.
Sponsors
Stiftelsen Stockholms Sjukhem
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of idiopathic Parkinson´s disease * Hoehn \& Yahr (Parkinsons progression scale) 1-3 * ≥ 50 years of age * Able to ambulate indoors without mobility aid * Able to walk continually with/without a walking aid for at least 6 minutes
Exclusion criteria
* Cognitive impairment affecting the ability to understand or follow verbal or written instructions (Montreal Cognitive Assessment ≤ 21 points * Major problems with freezing and/or two or more falls in the month previous to inclusion * Other existing neurological/ orthopedic or cardiovascular disease which impedes the performance of unsupervised exercise * Impaired vision and/or impaired communication which hinders participation * No internet connection in the home
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Balance ability | Change at 10 weeks | MiniBest test. Scoring 0-28, lower scores = greater balance impairment |
| Executive function | Change at 10 weeks | Trail making test A \& B. Expressed as time required to perform the test (seconds) |
| Balance Confidence | Change at 10 weeks and one year post-intervention | The Activities-specific Balance Confidence scale is a measure of confidence performing in various activities without losing balance or experiencing unsteadiness. A 16-item self-report measure with items rated on a rating scale that ranges from 0-100. A higher score indicates higher balance confidence. |
| Health-related Quality of Life | Change at 10 weeks and one year post-intervention | The EQ-5D is a two-part instrument that measures health-related quality of life. It examines 5 domains of quality of life: mobility, self-care, daily activities, pain, anxiety/depression. It comprises 5 questions and a visual scale. |
| Exercise Self-Efficacy | Change at 10 weeks and one year post-intervention | The Exercise Self-Efficacy Scale is an instrument examining confidence regarding carrying out regular physical activities and exercise. Questions are answered on a 4-point rating scale. A higher score indicates greater confidence. |
| Walking ability | Change at 10 weeks and one year post-intervention | The Walk-12 questionnaire examines limitations in walking ability. It consists of 12 questions answered on either a 3-point or 5-point rating scale. |
| Hospital Anxiety and Depression Scale | Change at 10 weeks and one year post-intervention | A 14-item measure designed to reflect the state of generalised anxiety and depression. The respondent rates each item on a 4-point scale. Higher scores indicate greater levels of anxiety or depression. |
| Life Space Assessment | Change at 10 weeks and one year post-intervention in only the final cohort of participants | The LSA is a self-report measure of the frequency of independent mobility across 5 life-space levels. Higher scores indicate more life-space and movement throughout the community. |
| Global Positioning System | Change at 10 weeks and one year post-intervention in only the final cohort of participants | GPS monitors collecting participant daily location and movement data via latitude and longitude coordinates collected throughout waking hours. |
| 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 and one year post-intervention | 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 |
| 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 |
| Physical activity measured with accelerometers | Change at 10 weeks and one year post-intervention | Steps per day and time (minutes) in different physical activity intensities (high,moderate and low intensity) |
Countries
Sweden
Contacts
STUDY_CHAIRMaria Ankarcrona, PhD
Karolinska Institutet, NVS
STUDY_CHAIRSofia Pettersson, MSc
Stockholms Sjukhem Foundation, Primary Care Rehabilitation
Outcome results
None listed