Idiopathic Parkinson DiseaseNCT05027620
Feasibility of Motor-cognitive Home Training for Parkinson's Disease Using eHealth Technology
A study testing Motor-cognitive exercise therapy in the home in people with Idiopathic Parkinson Disease and Telerehabilitation, run by Stiftelsen Stockholms Sjukhem at 1 site in Sweden.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Idiopathic Parkinson Disease, Telerehabilitation, Physical Therapy
- What is being tested?
- Motor-cognitive exercise therapy in the home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 5 Oct 2021to 14 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Being tested
- Motor-cognitive exercise therapy in the home
- Keywords
- Motor-cognitive training, Home training
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor-cognitive exercise therapy in the homeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Home training | Experimental | Participants train 3 times weekly in their home environment with help of a digital training app, over a 10-week period. Receives: Other: Motor-cognitive exercise therapy in the home |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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'.
Measured: 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.
Measured: 10 week period
Secondary outcomes (11)
Habitual physical activity
Measured by the ActiGraph accelerometer model GT3X+ (ActiGraph, Pensacola, FL, US) worn on the hip for seven consecutive days
Measured: 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
Measured: 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
Measured: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Self-reported walk ability
Walk-12 G Questionnaire
Measured: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Lower extremity function
30 second chair stand test
Measured: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Balance performance
Mini Balance Evaluation Systems Test (Mini-BESTest)
Measured: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Self-reported balance confidence
Activity-specific Balance Confidence (ABC) scale
Measured: 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)
Measured: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Exercise self-efficacy
Swedish Exercise Self-Efficacy Scale (S-ESES)
Measured: 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.
Measured: 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.
Measured: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start5 Oct 2021
- Primary completion14 Jan 2022
- Study completion14 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility study
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiftelsen Stockholms Sjukhem
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Breiffni Leavy, Stiftelsen Stockholms Sjukhem
- Investigators
- Breiffni Leavy, PhD, Principal investigator, Stockholms sjukhem and Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027620
- Sponsor's protocol ID
- 2020-03655
- Status last verified
- May 2022
- First submitted
- 12 Aug 2021
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sedhed J, Johansson H, Andersson N, Akesson E, Kalbe E, Franzen E, Leavy B. Feasibility of a novel eHealth intervention for Parkinson's disease targeting motor-cognitive function in the home. BMC Neurol. 2024 Apr 5;24(1):114. doi: 10.1186/s12883-024-03614-2.
PubMed 38580913
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continued Support for Physical Activity in Everyday Life With Parkinson's Disease Using eHealth Technology
- ClinicalTrials.gov ID
- NCT05027620
- Acronym / sponsor ID
- 2020-03655
- Keywords
- Motor-cognitive training, Home training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Stiftelsen Stockholms SjukhemUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study
| Arm | Type | Receives |
|---|---|---|
| Home training | Experimental | Other: Motor-cognitive exercise therapy in the homeParticipants train 3 times weekly in their home environment with help of a digital training app, over a 10-week period. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor-cognitive exercise therapy in the homeParticipants 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. | Other | Home training |
Primary outcome
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 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 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.
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'.
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.
11 secondary outcomes
Habitual physical activity
Time frame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Usual and fast walking speed
Time frame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Functional capacity as well as dual task gait ability
Time frame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Self-reported walk ability
Time frame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Lower extremity function
Time frame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Balance performance
Time frame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Self-reported balance confidence
Time frame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Self-reported difficulties across 8 dimensions of daily living
Time frame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Exercise self-efficacy
Time frame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Executive Function
Time frame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Verbal Fluency
Time frame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Derived from this study: PubMed 38580913Sedhed J, Johansson H, Andersson N, Akesson E, Kalbe E, Franzen E, Leavy B. Feasibility of a novel eHealth intervention for Parkinson's disease targeting motor-cognitive function in the home. BMC Neurol. 2024 Apr 5;24(1):114. doi: 10.1186/s12883-024-03614-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Breiffni Leavy, PhD principal investigator
Stockholms sjukhem and Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor-cognitive exercise therapy in the home in people with Idiopathic Parkinson Disease and Telerehabilitation, run by Stiftelsen Stockholms Sjukhem at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant satisfaction with the eHealth intervention (time frame: 10-week period.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05027620, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.