Clinical trial NCT04816825: Home-monitored Telerehabilitation in COPD Patients
Official title: Feasibility and Effectiveness of a Home Monitored Rehabilitation Intervention Using an Exergaming Approach in COPD Patients - a Randomized, Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Copd
Keywords: COPD
Telerehabilitation
Pulmonary rehabilitation
exergaming
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2021-03-25
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized clinical controlled study
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Physical activity
timeFrame: Baseline and 12 weeks after baseline
Secondary outcomes:
measure: Exercise capacity
timeFrame: Baseline and 12 weeks after baseline
measure: Exercise capacity
timeFrame: Baseline and 12 weeks after baseline
measure: Exercise capacity
timeFrame: Baseline and 12 weeks after baseline
measure: Body composition
timeFrame: Baseline and 12 weeks after baseline
measure: Body composition
timeFrame: Baseline and 12 weeks after baseline
measure: Body strength
timeFrame: Baseline and 12 weeks after baseline
measure: Body strength
timeFrame: Baseline and 12 weeks after baseline
measure: Health-related quality of life
timeFrame: Baseline and 12 weeks after baseline
measure: Health-related quality of life
timeFrame: Baseline and 12 weeks after baseline
measure: Number of exacerbations
timeFrame: Baseline and 12 weeks after baseline
measure: Healthcare utilization
timeFrame: Baseline and 12 weeks after baseline
measure: Healthcare utilization
timeFrame: Baseline and 12 weeks after baseline
Other outcomes:
measure: Performance and safety of the device
timeFrame: Baseline and 12 weeks after baseline
Locations:
city: Gothenburg
country: Sweden
facility: COPD-Center
state: VGR
Study officials:
References: