Clinical trial NCT05510739: Support for Physical Activity in Everyday Life With Parkinson's Disease
Official title: Support for Physical Activity in Everyday Life With Parkinson's Disease Using eHealth Technology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Physical Activity
eHealth
Gait Disorders, Neurologic
Lead sponsor: Stiftelsen Stockholms Sjukhem
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2022-08-22
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic Parkinson´s disease
* Hoehn \& Yahr (Parkinsons progression scale) 2-3
* ≥ 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

Primary outcomes:
measure: The six minute walk test
timeFrame: Change in balance performance at 10 weeks
Secondary outcomes:
measure: Gait parameters during single and dual-task conditions
timeFrame: Change at 10 weeks
measure: Quality of life questionnaires
timeFrame: Change at 10 weeks
measure: Physical activity measured with accelerometers
timeFrame: Change at 10 weeks
measure: Dual-task ability during walking
timeFrame: Change at 10 weeks
measure: Balance ability
timeFrame: Change at 10 weeks
measure: Executive function
timeFrame: Change at 10 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Stockholms sjukhem
Study officials:
affiliation: Karolinska Institutet, NVS
name: Maria Ankarcrona, PhD
role: STUDY_CHAIR
affiliation: Stockholms Sjukhem Foundation, Primary Care Rehabilitation
name: Alexis Wärmländer, MD
role: STUDY_CHAIR
References: