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Completed

NCT Number: NCT05027620

Feasibility of Motor-cognitive Home Training for 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

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Key information

Conditions

Idiopathic Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Physical Therapy Synucleinopathies Telerehabilitation

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stockholms Sjukhem

Stockholm, 112 19, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Motor-cognitive exercise therapy in the home

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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'.

  5. 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

  1. Habitual physical activity

    Time frame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)

    Measured by the ActiGraph accelerometer model GT3X+ (ActiGraph, Pensacola, FL, US) worn on the hip for seven consecutive days

  2. Usual and fast walking speed

    Time frame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)

    10 meter walk test at self-selected and fast speeds respectively

  3. Functional capacity as well as dual task gait ability

    Time frame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)

    Assessed during the 2 minute walk test (2MWT) in single and dual task conditions

  4. Self-reported walk ability

    Time frame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)

    Walk-12 G Questionnaire

  5. Lower extremity function

    Time frame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)

    30 second chair stand test

  6. Balance performance

    Time frame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)

    Mini Balance Evaluation Systems Test (Mini-BESTest)

  7. Self-reported balance confidence

    Time frame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)

    Activity-specific Balance Confidence (ABC) scale

  8. Self-reported difficulties across 8 dimensions of daily living

    Time frame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)

    The Parkinson's Disease Questionnaire -39 (PDQ-39)

  9. Exercise self-efficacy

    Time frame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)

    Swedish Exercise Self-Efficacy Scale (S-ESES)

  10. Executive Function

    Time frame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)

    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.

  11. Verbal Fluency

    Time frame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)

    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.

Sponsors and collaborators

Lead sponsor

Stiftelsen Stockholms Sjukhem

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 30, 2021
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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