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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motor-cognitive exercise using eHealth | Experimental | 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. |
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| Individualised home training program | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motor-cognitive home exercise supported by eHealth technology | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The six minute walk test | This test measures walking capacity by measuring the distance covered (meters) over a time period of 6 minutes. | Change in balance performance at 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gait parameters during single and dual-task conditions | Stride length (meters); Cadence (steps/ minute) will be captured using born-worn inertial sensors | Change at 10 weeks |
| Quality of life questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Ankarcrona, PhD | Karolinska Institutet, NVS | Study Chair |
| Sofia Pettersson, MSc | Stockholms Sjukhem Foundation, Primary Care Rehabilitation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stockholms sjukhem | Stockholm | 141 83 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37794320 | Result | Leavy B, Sedhed J, Kalbe E, Akesson E, Franzen E, Johansson H. Design of the STEPS trial: a phase II randomized controlled trial evaluating eHealth-supported motor-cognitive home training for Parkinson's disease. BMC Neurol. 2023 Oct 4;23(1):356. doi: 10.1186/s12883-023-03389-y. |
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Currently we do not have IRB for sharing
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009043 | Motor Activity |
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Individualized home exercise program | Behavioral | Individualised home exercise program leaflet involving one initial instruction session. Written instructions involving dose and exercise progression. No support during the 10 week period. |
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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
| Change at 10 weeks and one year post-intervention |
| Physical activity measured with accelerometers | Steps per day and time (minutes) in different physical activity intensities (high,moderate and low intensity) | Change at 10 weeks and one year post-intervention |
| Dual-task ability during walking | Captured using the Auditory Stroop test during walking and expressed as percentage error of the task | Change at 10 weeks |
| Balance ability | MiniBest test. Scoring 0-28, lower scores = greater balance impairment | Change at 10 weeks |
| Executive function | Trail making test A & B. Expressed as time required to perform the test (seconds) | Change at 10 weeks |
| Balance Confidence | 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. | Change at 10 weeks and one year post-intervention |
| Health-related Quality of Life | 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. | Change at 10 weeks and one year post-intervention |
| Exercise Self-Efficacy | 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. | Change at 10 weeks and one year post-intervention |
| Walking ability | 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. | Change at 10 weeks and one year post-intervention |
| Hospital Anxiety and Depression Scale | 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. | Change at 10 weeks and one year post-intervention |
| Life Space Assessment | 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. | Change at 10 weeks and one year post-intervention in only the final cohort of participants |
| Global Positioning System | GPS monitors collecting participant daily location and movement data via latitude and longitude coordinates collected throughout waking hours. | Change at 10 weeks and one year post-intervention in only the final cohort of participants |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |