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

NCT ID: NCT05510739

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-19
• Study Completion Date: 2025-07-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Motor-cognitive home exercise supported by eHealth technology

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Individualized home exercise program

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Stiftelsen Stockholms Sjukhem

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Ankarcrona, PhD

Role: STUDY_CHAIR

Karolinska Institutet, NVS

Sofia Pettersson, MSc

Role: STUDY_CHAIR

Stockholms Sjukhem Foundation, Primary Care Rehabilitation

Locations

Stockholms sjukhem

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 37794320 (View on PubMed)

Other Identifiers

StockholmsSjukhem

Identifier Type: -

Identifier Source: org_study_id