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Support for Physical Activity in Everyday Life With Parkinson's Disease (STEPS-PD)

Primary Purpose

Parkinson Disease, Physical Activity, eHealth

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Motor-cognitive home exercise supported by eHealth technology
Individualized home exercise program
Sponsored by
Stiftelsen Stockholms Sjukhem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stockholms sjukhemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motor-cognitive exercise using eHealth

Individualised home training program

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 25, 2022
Last Updated
June 22, 2023
Sponsor
Stiftelsen Stockholms Sjukhem
Collaborators
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT05510739
Brief Title
Support for Physical Activity in Everyday Life With Parkinson's Disease
Acronym
STEPS-PD
Official Title
Support for Physical Activity in Everyday Life With Parkinson's Disease Using eHealth Technology
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stiftelsen Stockholms Sjukhem
Collaborators
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Physical Activity, eHealth, Gait Disorders, Neurologic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motor-cognitive exercise using eHealth
Arm Type
Experimental
Arm Description
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.
Arm Title
Individualised home training program
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motor-cognitive home exercise supported by eHealth technology
Intervention Description
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
Intervention Name(s)
Individualized home exercise program
Intervention Description
Individualised home exercise program leaflet involving one initial instruction session. Written instructions involving dose and exercise progression. No support during the 10 week period.
Primary Outcome Measure Information:
Title
The six minute walk test
Description
This test measures walking capacity by measuring the distance covered (meters) over a time period of 6 minutes.
Time Frame
Change in balance performance at 10 weeks
Secondary Outcome Measure Information:
Title
Gait parameters during single and dual-task conditions
Description
Stride length (meters); Cadence (steps/ minute) will be captured using born-worn inertial sensors
Time Frame
Change at 10 weeks
Title
Quality of life questionnaires
Description
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
Time Frame
Change at 10 weeks
Title
Physical activity measured with accelerometers
Description
Steps per day and time (minutes) in different physical activity intensities (high,moderate and low intensity)
Time Frame
Change at 10 weeks
Title
Dual-task ability during walking
Description
Captured using the Auditory Stroop test during walking and expressed as percentage error of the task
Time Frame
Change at 10 weeks
Title
Balance ability
Description
MiniBest test. Scoring 0-27, higher scores = greater balance impairment
Time Frame
Change at 10 weeks
Title
Executive function
Description
Trail making test A & B. Expressed as time required to perform the test (seconds)
Time Frame
Change at 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Breiffni Leavy, PhD
Phone
0852488814
Email
breiffni.leavy@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Ankarcrona, PhD
Organizational Affiliation
Karolinska Institutet, NVS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alexis Wärmländer, MD
Organizational Affiliation
Stockholms Sjukhem Foundation, Primary Care Rehabilitation
Official's Role
Study Chair
Facility Information:
Facility Name
Stockholms sjukhem
City
Stockholm
ZIP/Postal Code
141 83
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Breiffni Leavy, PhD
Phone
0852488814
Email
breiffni.leavy@ki.se

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Currently we do not have IRB for sharing

Learn more about this trial

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

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