Support for Physical Activity in Everyday Life With Parkinson's Disease (STEPS-PD)

Stiftelsen Stockholms Sjukhem

Status: Enrolling

Conditions: Physical Activity; Gait Disorders, Neurologic; eHealth; Parkinson Disease

Treatments: Behavioral: Individualized home exercise program; Behavioral: Motor-cognitive home exercise supported by eHealth technology

Study type: Interventional

Funder types: Other

Identifiers

NCT05510739

StockholmsSjukhem

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Motor-cognitive exercise using eHealth

Experimental group

Description:

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.

Treatment:

Behavioral: Motor-cognitive home exercise supported by eHealth technology

Individualised home training program

Active Comparator group

Description:

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.

Treatment:

Behavioral: Individualized home exercise program