Home-monitored Telerehabilitation in COPD Patients
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|ClinicalTrials.gov Identifier: NCT04816825|
Recruitment Status : Recruiting
First Posted : March 25, 2021
Last Update Posted : March 29, 2021
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:
- 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.
- To investigate if the home-based exergaming program is associated with less exacerbations.
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A randomized clinical controlled study|
|Masking:||None (Open Label)|
|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|
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
- 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
- Exercise capacity [ Time Frame: Baseline and 12 weeks after baseline ]Change in submaximal exercise capacity will be measured by 6-Minute Walking Test.
- 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.
- 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).
- 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.
- 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.
- 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).
- Body strength [ Time Frame: Baseline and 12 weeks after baseline ]Change in muscle endurance will be measured by a shoulder flexion test (SFT).
- 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.
- 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.
- 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.
- Healthcare utilization [ Time Frame: Baseline and 12 weeks after baseline ]Change in healthcare utilization will be measured by number of hospital admissions for COPD.
- 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.
- 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.
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
|Contact: Lowie Vanfleterenfirstname.lastname@example.org|
|Gothenburg, VGR, Sweden, 413 45|
|Contact: Lowie Vanfleteren 0046736601730 email@example.com|
|Principal Investigator: Lowie Vanfleteren|