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

NCT05510739 | Active Not Recruiting

• 1 other identifier: StockholmsSjukhem
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Gait parameters during single and dual-task conditions

  Change at 10 weeks

• Quality of life questionnaires

  Change at 10 weeks and one year post-intervention

• Physical activity measured with accelerometers

  Change at 10 weeks and one year post-intervention

• Dual-task ability during walking

  Change at 10 weeks

• Balance ability

  Change at 10 weeks

Study Arms (2)

Motor-cognitive exercise using eHealth

EXPERIMENTAL

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

Individualised home training program

ACTIVE COMPARATOR

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

Interventions

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.

Motor-cognitive exercise using eHealth

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.

Individualised home training program

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cognitive impairment affecting the ability to understand or follow verbal or written instructions (Montreal Cognitive Assessment ≤ 21 points
• 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

Sponsors & Collaborators

• Stiftelsen Stockholms Sjukhem: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Stockholms sjukhem

Stockholm, 141 83, Sweden

Location

Related Publications (1)

• 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.

  PMID: 37794320 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Motor Activity; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Ankarcrona, PhD

  Karolinska Institutet, NVS

  STUDY CHAIR

• Sofia Pettersson, MSc

  Stockholms Sjukhem Foundation, Primary Care Rehabilitation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 22, 2022
• Study Start: September 19, 2022
• Primary Completion: June 11, 2024
• Study Completion: July 1, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)