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

Not Applicable

Recruiting

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

• Registration Number: NCT05510739
• Lead Sponsor: Stiftelsen Stockholms Sjukhem

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. 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 Timeline

• Study First Submitted: 2022-07-25
• Study First Submitted QC: 2022-08-19
• Study First Posted: 2022-08-22
• Study Start: 2022-09-19
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-22
• Last Update Posted: 2023-06-26
• Primary Completion: 2023-12
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Motor-cognitive exercise using eHealth	Motor-cognitive home exercise supported by eHealth technology	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.
Individualised home training program	Individualized home exercise 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.

Primary Outcome Measures

Name	Time	Method
The six minute walk test	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 Outcome Measures

Name	Time	Method
Quality of life questionnaires	Change at 10 weeks	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
Dual-task ability during walking	Change at 10 weeks	Captured using the Auditory Stroop test during walking and expressed as percentage error of the task
Executive function	Change at 10 weeks	Trail making test A \& B. Expressed as time required to perform the test (seconds)
Gait parameters during single and dual-task conditions	Change at 10 weeks	Stride length (meters); Cadence (steps/ minute) will be captured using born-worn inertial sensors
Physical activity measured with accelerometers	Change at 10 weeks	Steps per day and time (minutes) in different physical activity intensities (high,moderate and low intensity)
Balance ability	Change at 10 weeks	MiniBest test. Scoring 0-27, higher scores = greater balance impairment

Trial Locations

Locations (1)

Stockholms sjukhem; 🇸🇪 Stockholm, Sweden