TelemedicinebletheRDNCT03713151
Feasibility of a Blended Therapy Approach
A study testing Dividat FIT in people with Telemedicine and Exercise, run by University of Zurich at 1 site in Switzerland.
Trial summary
Exercise is an important part of therapy guidelines in the rehabilitation of rare diseases (RDs) as Haemophilia and Myositis. The aim of this study is not to evaluate a new therapy intervention, but to evaluate the delivery of this intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Telemedicine, Exercise, Feasibility
- What is being tested?
- Dividat FIT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Feb 2019to 30 Apr 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of mild Haemophilia or Myositis
- able to walk 20 meters without walking aids
- currently exercising less than one training session per week (training = vigorous activity)
- maintenance of a stable medical regimen for 4 weeks prior to initiation of study and considered to maintain a stable regimen for the course of the study
- signed informed consent to participate in the study
Who cannot join
- Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, severe cardiovascular and/or pulmonary disease, severe osteoporosis, pulmonary hypertension, pain syndrome, paresis)
- Contraindications to physical exercise for People with Haemophila: Factor-prophylaxis-regimen, inhibitor positive, less than 6 months after arthroplasty surgery, acute joint or muscle bleeding within the last 30 days for People With Myosites: acute exacerbation of inflammation
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Participation in another study with investigational drug within the 30 days preceding and during the present study
- Known pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of a Blended Therapy Approach: Face-to-face Physiotherapy Sessions Combined With an Interactive Tablet-based Exercise Program for People With Rare Diseases.
Exercise is an important part of therapy guidelines in the rehabilitation of rare diseases (RDs) as Haemophilia and Myositis. The aim of this study is not to evaluate a new therapy intervention, but to evaluate the delivery of this intervention. In clinical practice, patients are usually instructed to perform an exercise program at home. Normally, a physiotherapist (PT) provides an instruction (paper-) sheet. In this study, the investigators evaluate the feasibility of an interactive tablet-based way of delivery. The exercise program is - as usual in physiotherapy - individually tailored by the PT.
Read the detailed description
Myositis and haemophilia belong with a prevalence rate of 0.4-17.3 of 100'000 and 2-12 of 100'000, respectively to the group of RDs. The fact that a RD affects only a small number of people, indicates that rehabilitation knowledge outside the specialised medical centers is rare. Thus, since many people with RD do not live nearby these institutions, they do not have direct acces to rehabilitation programmes. The University Hospital Zurich (USZ) offers medical treatment and Rehabilitation Support in such reference centers, among others for people with myositis (PWM) and for people with haemophilia (PWH).
Although these two diseases differ strongly in their underlying cause, affected persons are confronted with similar problems: PWM and PWH suffer from musculoskeletal problems and therefore, a physically active lifestyle is essential to maintain good health. Nevertheless, PWM and PWH were previously discouraged from participating in physical exercise. Consequently, both groups are less physically active, have a lower fitness level and a higher risk for comorbidities, compared to healthy people. Nowadays, the beneficial effects of exercise in PWH and in PWM are well accepted and there is evidence that PWH and PWM profit from physical exercise programs.
Despite the encouraging benefits of physical exercise in PWH and PWM, these may be challenged with more barriers to start and maintain an exercise program, compared to healthy persons, e.g. due to reduced accessibility of specialised physiotherapists.
Telerehabilitation (TR), a subfield of telemedicine, may help to overcome some of the barriers to exercise regularly and connect PWH/PWM with specialised physiotherapists. TR is defined as the provision of rehabilitation services from a distance using telecommunication technologies as the delivery medium. This approach may optimize the timing, intensity and sequencing of interventions and provide opportunities for individuals to receive rehabilitation in their own social and professional environments from disease-specialised caregivers. An additional advantage of TR is the possibility to implement different persuasive technologies such as personalisation, self-monitoring, tailoring, goal setting, comparison and conditioning through positive and negative reinforcement in the development of exercise programmes. These technologies help to make exercise programmes more enjoyable and, therefore, enhance patients' motivation to exercise regularly.
Furthermore, the importance of individual and social support has been emphasized in several reviews evaluating health behaviour change for example becoming more active. This kind of support can be integrated in the design of a TR program and it can further be enhanced by blending TR with face-to-face sessions. The so-called blended therapy is a promising approach combining the advantages from traditional rehabilitation and new technologies.
The aim of this study is to evaluate feasibility of a blended therapy approach, combining a tablet-based exercise program, called "Dividat Fit" with face-to-face therapy sessions for PWH and PWM.
- Conditions
- Telemedicine, Exercise, Feasibility, Myositis, Haemophilia
- Being tested
- Dividat FIT
- Keywords
- Telemedicine, Feasibility, Exercise
- Medical subject headings
- Motor Activity, Myositis, Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dividat FITOther
The study intervention is a blended therapy approach of face-to-face physiotherapy sessions with an interactive tablet-based home exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Dividat FIT: Computer based exercise | Experimental | One arm with 10-15 Haemophilia patients and 10-15 Myositis patients. Receives: Other: Dividat FIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients recruited in the study
Recruitment rate, reasons for denial and exlusion and drop-outs
Measured: Will be assessed approximately 6 months after start of study
Secondary outcomes (13)
Adherence to the "Dividat Fit" exercise program
Number of completed training sessions
Measured: Will be assessed approximately 6 months after start of study
Perceived usefulness and perceived ease of use of Dividat Fit
Technology Assessment Model Questionnaire : 7-point Likert scale ranging from "strongly disagree" (rated as 1) to "strongly agree" (rated as 7). The TAM model can explain the users' motivation by three factors in subscales: perceived ease of use, perceived usefulness and attitude toward using the Technology.
Measured: 10 Minutes for each patient after the end of the 12-week intervention program
Perceived satisfaction of Dividat FIT
Satisfaction Questionnaire : 5-point Likert scale ranging from "strongly agree" (rated as 1) to "strongly disagree" (rated as 5). The model can explain the users' satisfaction rating by following factors in subscales: Satisfaction of physiotherapy sessions, satisfaction of the home program, satisfaction of the technical aspects and aspects that improved the motivation for the computer exercise program.
Measured: 10 Minutes for each patient after the end of the 12-week intervention program
Hand-held dynamometry
Isometric Muscle Force
Measured: Measurement approximately, two weeks before the start of the exercise intervention and after the end of the 12-week intervention program.
Manual Muscle testing
MMT8 only for People with Myosites
Measured: Measurement approximately, two weeks before the start of the exercise intervention and after the end of the 12-week intervention program.
Expanded Timed Get-up-and-Go
ETGUG
Measured: Measurement approximately, two weeks before the start of the exercise intervention and after the end of the 12-week intervention program.
30 second chair stand
Chair raise
Measured: Measurement approximately, two weeks before the start of the exercise intervention and after the end of the 12-week intervention program.
30 second arm curl
lift a 1 kg weight above the head until the elbow is fully extended in a 30 second period at a comfortable pace
Measured: Measurement approximately, two weeks before the start of the exercise intervention and after the end of the 12-week intervention program.
Functional Index 2 Test (FI2) : Number of repetitions for muscle endurance
In the FI2 test, patients perform as many repetitions for the subscales schoulder flexion, shoulder abduction, head lift, hip flexion, step test, heel lift and toe lift at a standardised movement pace untill a maximal number of correct repetitions is reached (60 repetitions for shoulder flexion, shoulder abduction, head lift, hip flexion and step test and 120 repetitions for heel lift and toe lift).If the patient cannot keep up the pace or perform the correct movement, then the amount of the correctly performed repetitions for a subscale is noted.
Measured: Measurement approximately, two weeks before the start of the exercise intervention and after the end of the 12-week intervention program.
Stanford Health Assessment Questionnaire Disability Index (HAQ)
The HAQ consists of 20 questions divided into eight subscales on a 4 Point likert scale: Dressing, rising, eating, walking, hygiene, reaching, grip function, and performing activities. Each question asks on a scale ranging from 0 to 3 if the categories can be performed without any difficulty (scale 0) up to cannot be done at all (scale 3). The summed subscores are divided by 8, to receive the total score.
Measured: Measurement approximately, two weeks before the start of the exercise intervention and after the end of the 12-week intervention program.
Health related disability and quality of life (SF-36)
The SF-36 is a generic patient-reported outcome measure aimed at quantifying health related quality of life (HRQOL). The SF-36 includes 36 questions divided in eight subscales: Limitations in physical activities because of health problems, limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems; bodily pain; general mental health (psychological distress and well-being), limitations in usual role activities because of emotional problems, vitality (energy and fatigue), general health perceptions. The eight subscales can be divided into two main components: physical component summary (PCS) and mental component summary (MCS). In the two main components higher scores indicate better HRQOL.
Measured: Measurement approximately, two weeks before the start of the exercise intervention and after the end of the 12-week intervention program.
Myositis Activity Profile questionnaire (MAP)
The MAP includes 32 items which can be answered on a 7-point Likert scale; where 1= no difficulty to perform and 7= impossible to perform. These items are divided into four subscales (movement activities, activities of moving around, personal care, and domestic activities) and four single items (keeping in touch with close friends and relatives, avoiding overexertion during daily activities, being able to cope with work and/or housework to a satisfactory degree, and being able to do recreational activities of choice).
Measured: Measurement approximately, two weeks before the start of the exercise intervention and after the end of the 12-week intervention program.
Haemophilia & Exercise Project-Test-Questionnaire (HEP-Test-Q)
The HEP-Test-Q is a questionnaire, assessing subjective physical performance of patients with haemophilia. It consists of 25 items pertaining to four domains "mobility", "strength \& coordination", "endurance" and "body perception" and one single item, which assesses changes in physical functioning in comparison to the previous year. Each item can be answered on a 5-point ordinal scale varying from 1 (never) to five (always).
Measured: Measurement approximately, two weeks before the start of the exercise intervention and after the end of the 12-week intervention program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start27 Feb 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
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 TelemedicineStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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 with a pre-post comparison
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruud Knols, PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713151
- Sponsor's protocol ID
- 2018-00970
- Other IDs
- 2018
- Acronym
- bletheRD
- Status last verified
- Jul 2020
- First submitted
- 29 Aug 2018
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pfister PB, Knols RH, de Bie RA, de Bruin ED. Feasibility of a blended therapy approach in the treatment of patients with inflammatory myopathies. Arch Physiother. 2021 May 27;11(1):14. doi: 10.1186/s40945-021-00108-z.
PubMed 34039438
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Blended Therapy Approach: Face-to-face Physiotherapy Sessions Combined With an Interactive Tablet-based Exercise Program for People With Rare Diseases.
- ClinicalTrials.gov ID
- NCT03713151
- Acronym / sponsor ID
- bletheRD / 2018-00970
- Conditions
- Telemedicine, Exercise, Feasibility, Myositis, Haemophilia
- Keywords
- Telemedicine, Feasibility, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 19 Oct 2018 (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.
Exercise is an important part of therapy guidelines in the rehabilitation of rare diseases (RDs) as Haemophilia and Myositis. The aim of this study is not to evaluate a new therapy intervention, but to evaluate the delivery of this intervention. In clinical practice, patients are usually instructed to perform an exercise program at home. Normally, a physiotherapist (PT) provides an instruction (paper-) sheet. In this study, the investigators evaluate the feasibility of an interactive tablet-based way of delivery. The exercise program is - as usual in physiotherapy - individually tailored by the PT.
Detailed description
Myositis and haemophilia belong with a prevalence rate of 0.4-17.3 of 100'000 and 2-12 of 100'000, respectively to the group of RDs. The fact that a RD affects only a small number of people, indicates that rehabilitation knowledge outside the specialised medical centers is rare. Thus, since many people with RD do not live nearby these institutions, they do not have direct acces to rehabilitation programmes. The University Hospital Zurich (USZ) offers medical treatment and Rehabilitation Support in such reference centers, among others for people with myositis (PWM) and for people with haemophilia (PWH).
Although these two diseases differ strongly in their underlying cause, affected persons are confronted with similar problems: PWM and PWH suffer from musculoskeletal problems and therefore, a physically active lifestyle is essential to maintain good health. Nevertheless, PWM and PWH were previously discouraged from participating in physical exercise. Consequently, both groups are less physically active, have a lower fitness level and a higher risk for comorbidities, compared to healthy people. Nowadays, the beneficial effects of exercise in PWH and in PWM are well accepted and there is evidence that PWH and PWM profit from physical exercise programs.
Despite the encouraging benefits of physical exercise in PWH and PWM, these may be challenged with more barriers to start and maintain an exercise program, compared to healthy persons, e.g. due to reduced accessibility of specialised physiotherapists.
Telerehabilitation (TR), a subfield of telemedicine, may help to overcome some of the barriers to exercise regularly and connect PWH/PWM with specialised physiotherapists. TR is defined as the provision of rehabilitation services from a distance using telecommunication technologies as the delivery medium. This approach may optimize the timing, intensity and sequencing of interventions and provide opportunities for individuals to receive rehabilitation in their own social and professional environments from disease-specialised caregivers. An additional advantage of TR is the possibility to implement different persuasive technologies such as personalisation, self-monitoring, tailoring, goal setting, comparison and conditioning through positive and negative reinforcement in the development of exercise programmes. These technologies help to make exercise programmes more enjoyable and, therefore, enhance patients' motivation to exercise regularly.
Furthermore, the importance of individual and social support has been emphasized in several reviews evaluating health behaviour change for example becoming more active. This kind of support can be integrated in the design of a TR program and it can further be enhanced by blending TR with face-to-face sessions. The so-called blended therapy is a promising approach combining the advantages from traditional rehabilitation and new technologies.
The aim of this study is to evaluate feasibility of a blended therapy approach, combining a tablet-based exercise program, called "Dividat Fit" with face-to-face therapy sessions for PWH and PWM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study with a pre-post comparison
| Arm | Type | Receives |
|---|---|---|
| Dividat FIT: Computer based exercise | Experimental | Other: Dividat FITOne arm with 10-15 Haemophilia patients and 10-15 Myositis patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of mild Haemophilia or Myositis
- able to walk 20 meters without walking aids
- currently exercising less than one training session per week (training = vigorous activity)
- maintenance of a stable medical regimen for 4 weeks prior to initiation of study and considered to maintain a stable regimen for the course of the study
- signed informed consent to participate in the study
Key exclusion criteria (6 listed)
- Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, severe cardiovascular and/or pulmonary disease, severe osteoporosis, pulmonary hypertension, pain syndrome, paresis)
- Contraindications to physical exercise for People with Haemophila: Factor-prophylaxis-regimen, inhibitor positive, less than 6 months after arthroplasty surgery, acute joint or muscle bleeding within the last 30 days for People With Myosites: acute exacerbation of inflammation
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Participation in another study with investigational drug within the 30 days preceding and during the present study
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 |
|---|---|---|
| Dividat FITThe study intervention is a blended therapy approach of face-to-face physiotherapy sessions with an interactive tablet-based home exercise program. | Other | Dividat FIT: Computer based exercise |
Primary outcome
Number of patients recruited in the study
Time frame: Will be assessed approximately 6 months after start of study
Recruitment rate, reasons for denial and exlusion and drop-outs
13 secondary outcomes
Adherence to the "Dividat Fit" exercise program
Time frame: Will be assessed approximately 6 months after start of study
Perceived usefulness and perceived ease of use of Dividat Fit
Time frame: 10 Minutes for each patient after the end of the 12-week intervention program
Perceived satisfaction of Dividat FIT
Time frame: 10 Minutes for each patient after the end of the 12-week intervention program
Hand-held dynamometry
Time frame: Measurement approximately, two weeks before the start of the exercise intervention and after the end of the 12-week intervention program.
Manual Muscle testing
Time frame: Measurement approximately, two weeks before the start of the exercise intervention and after the end of the 12-week intervention program.
Expanded Timed Get-up-and-Go
Time frame: Measurement approximately, two weeks before the start of the exercise intervention and after the end of the 12-week intervention program.
30 second chair stand
Time frame: Measurement approximately, two weeks before the start of the exercise intervention and after the end of the 12-week intervention program.
30 second arm curl
Time frame: Measurement approximately, two weeks before the start of the exercise intervention and after the end of the 12-week intervention program.
Functional Index 2 Test (FI2) : Number of repetitions for muscle endurance
Time frame: Measurement approximately, two weeks before the start of the exercise intervention and after the end of the 12-week intervention program.
Stanford Health Assessment Questionnaire Disability Index (HAQ)
Time frame: Measurement approximately, two weeks before the start of the exercise intervention and after the end of the 12-week intervention program.
Health related disability and quality of life (SF-36)
Time frame: Measurement approximately, two weeks before the start of the exercise intervention and after the end of the 12-week intervention program.
Myositis Activity Profile questionnaire (MAP)
Time frame: Measurement approximately, two weeks before the start of the exercise intervention and after the end of the 12-week intervention program.
Haemophilia & Exercise Project-Test-Questionnaire (HEP-Test-Q)
Time frame: Measurement approximately, two weeks before the start of the exercise intervention and after the end of the 12-week intervention program.
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 2 Jul 2020.
- Derived from this study: PubMed 34039438Pfister PB, Knols RH, de Bie RA, de Bruin ED. Feasibility of a blended therapy approach in the treatment of patients with inflammatory myopathies. Arch Physiother. 2021 May 27;11(1):14. doi: 10.1186/s40945-021-00108-z.
- Individual participant dataSharing planned: Undecided
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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.
Ruud Knols, PhD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dividat FIT in people with Telemedicine and Exercise, run by University of Zurich at 1 site in Switzerland.
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 6 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 2 Jul 2020. 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 Switzerland. 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?
Number of patients recruited in the study (time frame: Will be assessed approximately 6 months after start of study). 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 NCT03713151, 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 2 Jul 2020.