Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Home-monitored Telerehabilitation in COPD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04816825
Recruitment Status : Recruiting
First Posted : March 25, 2021
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
Lowie Vanfleteren, Vastra Gotaland Region

Brief Summary:

Study title Feasibility and effectiveness of a home monitored rehabilitation intervention using an exergaming approach in COPD patients - a randomized, controlled study.

Background and rationale Chronic Obstructive Pulmonary Disease (COPD) is a common chronic disease characterized by persistent airflow limitation caused by significant exposure to noxious particles or gases, particularly cigarette smoking. In Sweden the prevalence of COPD is approximately 8% and the annual estimated cost for society of 9.1 billion SEK. Improving exercise capacity and physical activity levels are important goals in management of patients with COPD and are strong determinants of positive outcomes, including increased quality of life. Major barrier for rehabilitation recommendations is the limited access and adherence to organized center-based exercise programs. Major barriers related to the side of health care organization are budgets and infrastructure and the limitation in time of the programs. From patient's perspective major barriers exist, like distance, and lack of transport to the unit, also in relation to the frequency of the program, which is commonly two times a week.

Research question and objectives The primary objective of this study is to investigate whether home-based telemonitored supervised exercise programs using an exergaming approach will be associated to improved physical fitness, measured with the (1-minute sit-to-stand test, 1-MSTST) compared to the ordinary care.

The secondary objectives of this study are:

  1. To investigate whether a home-based exergaming program is associated with improved health-related quality of life, exercise capacity, physical activity levels and body composition.
  2. To investigate if the home-based exergaming program is associated with less exacerbations.
  3. To investigate if the home-based exergaming program is associated with improved health care utilization and/or less hospitalization from all causes?

Study design This is an open label , randomized controlled clinical study. The study takes place at the COPD-center at Sahlgrenska University hospital. Subjects will be randomized to either the use of the ALKIT exergaming tool in combination with telemonitored supervision by a physiotherapist or ordinary care without this system at their first visit. A total of 92 subjects will be included in the study, 46 in every arm. The intervention will include exergames performed 3 times a week for 12 weeks, consistent with the current recommendations. Pre-and post-intervention tests will be performed and subjects in both groups will be assessed. The tests include: 1-minute sit-to-stand test, 6-minute walk test, and timed-up and go. Two self- assessed questionnaires will be filled in: COPD Assessment Test and EQ5D-5L. Subjects will be also measured for quadriceps muscle strength, shoulder flexion and body composition. Additionally, physical activity level will be assessed by outcomes of pedometer worn over a week. Moreover, exacerbations and health care utilization will be measured. Users' perception of the exergaming program will be also investigated.

Population and study size The study will include a total of 92 subjects, 46 in the intervention- and 46 in the control arm. For each participant, the total study participation time will be 12 weeks. A randomization list will be produced with random assignment of treatment groups in a ratio of 1:1


Condition or disease Intervention/treatment Phase
Copd Device: Alkit eSence Other: Standard rehabilitation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized clinical controlled study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Effectiveness of a Home Monitored Rehabilitation Intervention Using an Exergaming Approach in COPD Patients - a Randomized, Controlled Clinical Study
Actual Study Start Date : March 23, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exergaming
The combination of 1) game-console based exercise programs, 2) specifically designed by professional physiotherapists with focus on subjects with a chronic lung disease and 3) weekly distant monitoring with close supervision by a physiotherapist. Individually prescribed exercise program based on tests of patient's physical fitness.
Device: Alkit eSence
Home-based rehabilitation program including computer games and supervised by a physiotherapist.

Active Comparator: Standard rehabilitation
Standard rehabilitation at the COPD-Center. This includes recommendations about physical activity according to the general guidelines, however, individualized after each subject's physical fitness level.
Other: Standard rehabilitation
Standard rehabilitation program at the COPD-Center




Primary Outcome Measures :
  1. Physical activity [ Time Frame: Baseline and 12 weeks after baseline ]
    Change in level of physical activity will be objectively measured with 1-minute sit to stand test


Secondary Outcome Measures :
  1. Exercise capacity [ Time Frame: Baseline and 12 weeks after baseline ]
    Change in submaximal exercise capacity will be measured by 6-Minute Walking Test.

  2. Exercise capacity [ Time Frame: Baseline and 12 weeks after baseline ]
    Change in submaximal exercise capacity will be measured by Timed up and go (TUG) test.

  3. Exercise capacity [ Time Frame: Baseline and 12 weeks after baseline ]
    Change in submaximal exercise capacity will be assessed by outcomes of a pedometer (number of daily steps).

  4. Body composition [ Time Frame: Baseline and 12 weeks after baseline ]
    Change in body composition will be calculated by Body Mass Index (BMI) by a BIA device.

  5. Body composition [ Time Frame: Baseline and 12 weeks after baseline ]
    Change in body composition will be calculated by Fat Free Mass Index (FFMI) by a BIA device.

  6. Body strength [ Time Frame: Baseline and 12 weeks after baseline ]
    Change in quadriceps muscle strength measured by the One-Repetition Maximum test (1RM). Muscle endurance will be measured by a shoulder flexion test (SFT).

  7. Body strength [ Time Frame: Baseline and 12 weeks after baseline ]
    Change in muscle endurance will be measured by a shoulder flexion test (SFT).

  8. Health-related quality of life [ Time Frame: Baseline and 12 weeks after baseline ]
    Change in disease-specific quality of life by using a COPD Assessment Test (CAT) questionnaire. CAT measures COPD symptoms with scores from 0 to 5 points (0 indicating no impact or symptoms, 5- worst possible impact or symptoms) summing up to a total CAT score range of 0-40 points.

  9. Health-related quality of life [ Time Frame: Baseline and 12 weeks after baseline ]
    Change in general health-related quality of life will be measured by The 5-level EQ-5D EuroQoL (EQ5D-5L) questionnaire. First part of the questionnaire indicates health state in 5 dimentions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The total score ranges 5-25 and higher score indicates worse health condition. The second part of EQ5D-5L, the EQ VAS (Visual Analog Score) records the patient's self-rated health on a vertical visual analogue scale (0-100), where the endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0). This part will be used as a quantitative measure of health outcome that reflect the patient's own judgement.

  10. Number of exacerbations [ Time Frame: Baseline and 12 weeks after baseline ]
    Change in exacerbation incidence will be measured by number of courses of corticosteroids and/or antibiotics for a worsening of respiratory symptoms.

  11. Healthcare utilization [ Time Frame: Baseline and 12 weeks after baseline ]
    Change in healthcare utilization will be measured by number of hospital admissions for COPD.

  12. Healthcare utilization [ Time Frame: Baseline and 12 weeks after baseline ]
    Change in healthcare utilization will be measured by number of hospital admissions for all causes.


Other Outcome Measures:
  1. Performance and safety of the device [ Time Frame: Baseline and 12 weeks after baseline ]
    Users' perception of the exergaming program will be investigated by qualitative methods using short interviews or a self-made questionnaire. A total of 16 questions evaluate the rehabilitation with exergaming strategy and answers are assessed with Visual Analog Score (VAS), 0- strongly disagree, 5-strongry agree. The final score range from 0-80, where 80 indicates more positive feedback.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willingness to participate and signed informed consent form
  2. Diagnosis of COPD
  3. FEV1/FVC (post bronchodilator) <0.7
  4. GOLD severity grade B/D
  5. FEV, < 80% predicted
  6. Cognitive ability relevant for the studies as judged by the investigator
  7. Living in their own home and able to manage their activities of daily living

Exclusion Criteria:

  1. Rapidly progressing severe disease other than COPD and COPD-related diseases.
  2. Influencing the HRQOL during the study time as judged by the investigator, e.g. long-term stay (>2 weeks) away from home during the study period.
  3. Inability to communicate in Swedish.
  4. Any condition that may interfere with the possibility for the subject to comply with the study protocol.
  5. Already participating in the pulmonary rehabilitation training group 2 times a week.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04816825


Contacts
Layout table for location contacts
Contact: Lowie Vanfleteren 0046736601730 lowie.vanfleteren@vgregion.se

Locations
Layout table for location information
Sweden
COPD-Center Recruiting
Gothenburg, VGR, Sweden, 413 45
Contact: Lowie Vanfleteren    0046736601730    lowie.vanfleteren@vgregion.se   
Principal Investigator: Lowie Vanfleteren         
Sponsors and Collaborators
Vastra Gotaland Region
Layout table for additonal information
Responsible Party: Lowie Vanfleteren, Principal Investigator, Head of COPD-center, Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT04816825    
Other Study ID Numbers: ExerGaming
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Lowie Vanfleteren, Vastra Gotaland Region:
COPD
Telerehabilitation
Pulmonary rehabilitation
exergaming