Feasibility of Motor-cognitive Home Training for Parkinson's Disease Using eHealth Technology

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

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

Study Overview

• Status: Completed
• Conditions: Telerehabilitation; Physical Therapy; Idiopathic Parkinson Disease
• Intervention / Treatment: Other: Motor-cognitive exercise therapy in the home

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 112 19
    • Stockholms sjukhem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Home training; Participants train 3 times weekly in their home environment with help of a digital training app, over a 10-week period.

Other: Motor-cognitive exercise therapy in the home; Participants engage in a progressive 10-week exercise program targeted at improving motor and cognitive function. Motor exercises target functional strength, gait and physical activity level. Training sessions occur 3 times weekly and supported by a digital application which has been adapted for people with Parkinson's disease. Weeks 1-2 focus solely on motor exercises. Dual-task (Motor-cognitive) exercises are introduced at week 3 and progressed until week 10. Participants are also encouraged to increase the physical activity levels during the 10 week period. Weekly contact is made using the video function/ telephone with clinical specialists/ researchers. Two home visits will occur, the first one week prior to the intervention and at the 5-week period. Participants receive motivational messaging and reminders via the app during the intervention period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant satisfaction with the eHealth intervention	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.	10-week period.
Participants perceived intensity of the motor exercises	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.	10-week period.
Participants perceived difficulty of the motor-cognitive (dual-task) exercises	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.	10-week period.
Participants actual use of the eHealth training tool	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'.	10-week period.
Total number of adverse events during the training sessions	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.	10 week period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Habitual physical activity	Measured by the ActiGraph accelerometer model GT3X+ (ActiGraph, Pensacola, FL, US) worn on the hip for seven consecutive days	i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Usual and fast walking speed	10 meter walk test at self-selected and fast speeds respectively	i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Functional capacity as well as dual task gait ability	Assessed during the 2 minute walk test (2MWT) in single and dual task conditions	i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Self-reported walk ability	Walk-12 G Questionnaire	i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Lower extremity function	30 second chair stand test	i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Balance performance	Mini Balance Evaluation Systems Test (Mini-BESTest)	i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Self-reported balance confidence	Activity-specific Balance Confidence (ABC) scale	i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Self-reported difficulties across 8 dimensions of daily living	The Parkinson's Disease Questionnaire -39 (PDQ-39)	i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Exercise self-efficacy	Swedish Exercise Self-Efficacy Scale (S-ESES)	i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Executive Function	Attention and psychomotor processing speed will be assessed by the Trail making test (TMT) conditions 2 (letter Sequencing) and 4 (number-Letter Switching (set-shifting)) from Delis-Kaplan Executive Function System (D-KEFS). Results are presented as time in seconds.	i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Verbal Fluency	Verbal function, initiation & task-set switching will be assessed by the Verbal fluency (Letter Fluency, Category Fluency, and Category Switching) from Delis-Kaplan Executive Function System (D-KEFS). Raw scores are converted to scaled scores.	i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)

Collaborators and Investigators

• Sponsor: Stiftelsen Stockholms Sjukhem
• Investigators: Principal Investigator: Breiffni Leavy, PhD, Stockholms sjukhem and Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2021
• Primary Completion (Actual): January 14, 2022
• Study Completion (Actual): January 14, 2022

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Home training; Motor-cognitive training
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2020-03655

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No