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Parkinson DiseaseSTEPS-PDNCT05510739

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

A study testing Motor-cognitive home exercise supported by eHealth technology and Individualized home exercise program in people with Parkinson Disease and Physical Activity, run by Stiftelsen Stockholms Sjukhem at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Parkinson Disease, Physical Activity, eHealth
What is being tested?
Motor-cognitive home exercise supported by eHealth technology and Individualized home exercise program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
1 siteSweden
Study dates
19 Sep 2022to 19 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Sweden1 site

  • Stockholms sjukhem

    Stockholm, 141 83

Other trials in Sweden

About this study

Official title: 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.

Read the 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.

Being tested
Motor-cognitive home exercise supported by eHealth technology, Individualized home exercise program
Medical subject headings
Parkinson Disease, Motor Activity, Gait Disorders, Neurologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motor-cognitive home exercise supported by eHealth technologyBehavioural

    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 programBehavioural

    Individualised home exercise program leaflet involving one initial instruction session. Written instructions involving dose and exercise progression. No support during the 10 week period.

Study groups in NCT05510739
Study groupRoleWhat they receive
Motor-cognitive exercise using eHealthExperimental10-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.
Receives: Behavioral: Motor-cognitive home exercise supported by eHealth technology
Individualised home training programActive comparatorParticipants 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.
Receives: Behavioral: Individualized home exercise program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The six minute walk test

    This test measures walking capacity by measuring the distance covered (meters) over a time period of 6 minutes.

    Measured: Change in balance performance at 10 weeks

Secondary outcomes (13)

  1. Gait parameters during single and dual-task conditions

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

    Measured: Change at 10 weeks

  2. 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

    Measured: Change at 10 weeks and one year post-intervention

  3. Physical activity measured with accelerometers

    Steps per day and time (minutes) in different physical activity intensities (high,moderate and low intensity)

    Measured: Change at 10 weeks and one year post-intervention

  4. Dual-task ability during walking

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

    Measured: Change at 10 weeks

  5. Balance ability

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

    Measured: Change at 10 weeks

  6. Executive function

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

    Measured: Change at 10 weeks

  7. 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.

    Measured: Change at 10 weeks and one year post-intervention

  8. 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.

    Measured: Change at 10 weeks and one year post-intervention

  9. 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.

    Measured: Change at 10 weeks and one year post-intervention

  10. 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.

    Measured: Change at 10 weeks and one year post-intervention

  11. 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.

    Measured: Change at 10 weeks and one year post-intervention

  12. 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.

    Measured: Change at 10 weeks and one year post-intervention in only the final cohort of participants

  13. Global Positioning System

    GPS monitors collecting participant daily location and movement data via latitude and longitude coordinates collected throughout waking hours.

    Measured: Change at 10 weeks and one year post-intervention in only the final cohort of participants

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2022
  2. Study start19 Sep 2022
  3. Primary completion11 Jun 2024
  4. Study completion19 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05510739
Sponsor's protocol ID
StockholmsSjukhem
Acronym
STEPS-PD
Status last verified
Jun 2026
First submitted
25 Jul 2022
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Currently we do not have IRB for sharing

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.

    PubMed 37794320

Questions about this trial

What is this clinical trial studying?

A study testing Motor-cognitive home exercise supported by eHealth technology and Individualized home exercise program in people with Parkinson Disease and Physical Activity, run by Stiftelsen Stockholms Sjukhem at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The six minute walk test (time frame: Change in balance performance at 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05510739, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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