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Clinical Trials/NCT05027620
NCT05027620
Completed
N/A

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

Stiftelsen Stockholms Sjukhem1 site in 1 country15 target enrollmentOctober 5, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Idiopathic Parkinson Disease
Sponsor
Stiftelsen Stockholms Sjukhem
Enrollment
15
Locations
1
Primary Endpoint
Participants perceived intensity of the motor exercises
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to test the feasibility of a novel motor-cognitive home training intervention using eHealth technology among people with Parkinson's Disease

Registry
clinicaltrials.gov
Start Date
October 5, 2021
End Date
January 14, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Stiftelsen Stockholms Sjukhem
Responsible Party
Principal Investigator
Principal Investigator

Breiffni Leavy

Principal Investigator

Stiftelsen Stockholms Sjukhem

Eligibility Criteria

Inclusion Criteria

  • Neurologist diagnosed Idiopathic PD at least 6 months previous to inclusion.
  • Hoehn \& Yahr stages I-III
  • Stable in anti-Parkinson medications three months prior to inclusion.
  • The ability to walk walk independently indoors without a walking aid.
  • The ability to walk continually with/without a walking aid for at least 5 minutes.

Exclusion Criteria

  • Cognitive impairment affecting the ability to understand or follow verbal or written instructions (Montreal Cognitive Assessment ≤ 21 points).
  • Impaired vision and/or impaired communication which hinders participation.
  • 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 in the home.
  • No internet connection in the home.

Outcomes

Primary Outcomes

Participants perceived intensity of the motor exercises

Time Frame: 10-week period.

Participants will rate the intensity of the intervention using the Borg Rating of perceived, Exertion Scale (6-20) following each training session. According to this scale, lower numbers signify lower levels of exertion, and higher numbers signify higher levels of exertion. The aim is that participants levels of exertion will lie in the middle range (12-17) This will measure the feasibility outcome - Practicality or Ability to carry out the intervention.

Participants actual use of the eHealth training tool

Time Frame: 10-week period.

Total time logged in to the digital training app will be derived from system and expressed as a percentage of total recommended intervention time. This will measure the feasibility outcome - Demand of the intervention'.

Participant satisfaction with the eHealth intervention

Time Frame: 10-week period.

Participants will rate their satisfaction with using a digital survey following each training session. An average value will be calculated. This will measure the feasibility outcome - Acceptability of the intervention.

Participants perceived difficulty of the motor-cognitive (dual-task) exercises

Time Frame: 10-week period.

Participants will rate the difficulty of the dual-task exercises using a 0-10 scale (higher scores = higher degree of difficulty) following each exercise session and scores will be averaged over the study period following. This will measure the feasibility outcome - Suitability of the intervention.

Total number of adverse events during the training sessions

Time Frame: 10 week period

Participants will report all adverse events such as falls or other injuries acquired during the training session, during a once weekly telephone interview. This will measure the feasibility outcome Safety.

Secondary Outcomes

  • Exercise self-efficacy(i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training))
  • Lower extremity function(i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training))
  • Executive Function(i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training))
  • Functional capacity as well as dual task gait ability(i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training))
  • Self-reported walk ability(i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training))
  • Usual and fast walking speed(i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training))
  • Balance performance(i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training))
  • Self-reported difficulties across 8 dimensions of daily living(i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training))
  • Habitual physical activity(i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training))
  • Self-reported balance confidence(i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training))
  • Verbal Fluency(i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training))

Study Sites (1)

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