Feasibility of a Blended Therapy Approach

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03713151
• Date of registration: 29/08/2018
• Prospective Registration: Yes
• Primary sponsor: University of Zurich
• Public title: Feasibility of a Blended Therapy Approach bletheRD
• Scientific 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.
• Date of first enrolment: February 27, 2019
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03713151
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Ruud Knols, PhD
• Affiliation: University of Zurich

Key inclusion & exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Exercise

Feasibility

Myositis

Haemophilia

Telemedicine

Intervention(s)

Other: Dividat FIT

Primary Outcome(s)

Number of patients recruited in the study [Time Frame: Will be assessed approximately 6 months after start of study]

Secondary Outcome(s)

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.]

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.]

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.]

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.]

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.]

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]

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.]

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.]

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.]

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.]

Adherence to the "Dividat Fit" exercise program [Time Frame: Will be assessed approximately 6 months after start of study]

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.]

Perceived satisfaction of Dividat FIT [Time Frame: 10 Minutes for each patient after the end of the 12-week intervention program]

Secondary ID(s)

2018-00970

Source(s) of Monetary Support

Please refer to primary and secondary sponsors