Feasibility of a Blended Therapy Approach

NCT03713151 | Completed

• 1 other identifier: 2018-00970
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Telemedicine; Exercise; Feasibility; Myositis; Haemophilia

Keywords

Telemedicine, Feasibility, Exercise

Outcome Measures

Primary Outcomes (1)

• Number of patients recruited in the study

  Recruitment rate, reasons for denial and exlusion and drop-outs

  Will be assessed approximately 6 months after start of study

Secondary Outcomes (13)

• Adherence to the "Dividat Fit" exercise program

  Will be assessed approximately 6 months after start of study

• Perceived usefulness and perceived ease of use of Dividat Fit

  10 Minutes for each patient after the end of the 12-week intervention program

• Perceived satisfaction of Dividat FIT

  10 Minutes for each patient after the end of the 12-week intervention program

• Hand-held dynamometry

  Measurement approximately, two weeks before the start of the exercise intervention and after the end of the 12-week intervention program.

• Manual Muscle testing

  Measurement approximately, two weeks before the start of the exercise intervention and after the end of the 12-week intervention program.

Study Arms (1)

Dividat FIT: Computer based exercise

EXPERIMENTAL

One arm with 10-15 Haemophilia patients and 10-15 Myositis patients.

Other: Dividat FIT

Interventions

Dividat FIT OTHER

The study intervention is a blended therapy approach of face-to-face physiotherapy sessions with an interactive tablet-based home exercise program.

Dividat FIT: Computer based exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Ruud Knols

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 34039438 DERIVED

MeSH Terms

Conditions

Motor Activity; Myositis; Hemophilia A

Condition Hierarchy (Ancestors)

Behavior; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ruud Knols, PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility study with a pre-post comparison

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: October 19, 2018
• Study Start: February 27, 2019
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: July 2, 2020

Record last verified: 2020-07

Locations

CH (1)