Skip to main content
OpenTrials
Completed

NCT Number: NCT05510739

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Gait Disorders, Neurologic Motor Activity Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms Synucleinopathies eHealth

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stockholms sjukhem

Stockholm, 141 83, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. The six minute walk test

    Time frame: 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 outcomes

  1. Gait parameters during single and dual-task conditions

    Time frame: Change at 10 weeks

    Stride length (meters); Cadence (steps/ minute) will be captured using born-worn inertial sensors

  2. Quality of life questionnaires

    Time frame: 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

  3. Physical activity measured with accelerometers

    Time frame: 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)

  4. Dual-task ability during walking

    Time frame: Change at 10 weeks

    Captured using the Auditory Stroop test during walking and expressed as percentage error of the task

  5. Balance ability

    Time frame: Change at 10 weeks

    MiniBest test. Scoring 0-28, lower scores = greater balance impairment

  6. Executive function

    Time frame: Change at 10 weeks

    Trail making test A & B. Expressed as time required to perform the test (seconds)

  7. Balance Confidence

    Time frame: 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.

  8. Health-related Quality of Life

    Time frame: 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.

  9. Exercise Self-Efficacy

    Time frame: 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.

  10. Walking ability

    Time frame: 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.

  11. Hospital Anxiety and Depression Scale

    Time frame: 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.

  12. Life Space Assessment

    Time frame: 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.

  13. Global Positioning System

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stiftelsen Stockholms Sjukhem

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

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

Acronym: STEPS-PD

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Aug 22, 2022
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.