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

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

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Parkinson Disease; Gait Disorders, Neurologic; eHealth
• Intervention / Treatment: Behavioral: Motor-cognitive home exercise supported by eHealth technology; Behavioral: Individualized home exercise program

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 Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 141 83
    • Stockholms sjukhem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motor-cognitive exercise using eHealth; 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.	Behavioral: Motor-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.
Active Comparator: Individualised home training program; 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.	Behavioral: Individualized 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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
Executive function	Trail making test A & B. Expressed as time required to perform the test (seconds)	Change at 10 weeks
Quality of life questionnaires	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
Balance ability	MiniBest test. Scoring 0-28, lower scores = greater balance impairment	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

Collaborators and Investigators

• Sponsor: Stiftelsen Stockholms Sjukhem
• Collaborators: Karolinska Institutet
• Investigators: Study Chair: Maria Ankarcrona, PhD, Karolinska Institutet, NVS; Study Chair: Sofia Pettersson, MSc, Stockholms Sjukhem Foundation, Primary Care Rehabilitation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Actual): June 11, 2024
• Study Completion (Actual): September 19, 2025

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Parkinson Disease; Gait Disorders, Neurologic; Motor Activity
• Other Study ID Numbers: StockholmsSjukhem

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Currently we do not have IRB for sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No