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

Parkinson Disease Clinical Trial

— STEPS-PD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05510739
• Other study ID #: StockholmsSjukhem
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2022
• Est. completion date: March 2024

Study information

• Verified date: June 2023
• Source: Stiftelsen Stockholms Sjukhem
• Contact: Breiffni Leavy, PhD
• Phone: 0852488814
• Email: breiffni.leavy[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• eHealth
• Gait Disorders, Neurologic
• Nervous System Diseases
• Parkinson Disease
• Physical Activity

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Sweden	Stockholms sjukhem	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Stiftelsen Stockholms Sjukhem	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

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