Support for Physical Activity in Everyday Life With Parkinson's Disease

Not Applicable

Active, not recruiting

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

• Registration Number: NCT05510739
• Lead Sponsor: Stiftelsen Stockholms Sjukhem

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.

Study Timeline

• Study First Submitted: 2022-07-25
• Study First Submitted QC: 2022-08-19
• Study First Posted: 2022-08-22
• Study Start: 2022-09-19
• Primary Completion: 2024-06-11
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-27
• Study Completion: 2025-07-01
• Last Update Posted: 2025-07-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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.
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.
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
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.
Executive function	Change at 10 weeks	Trail making test A \& B. Expressed as time required to perform the test (seconds)
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
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.
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 0-28, lower scores = greater balance impairment

Trial Locations

Locations (1)

Stockholms sjukhem; 🇸🇪 Stockholm, Sweden