Home-monitored Telerehabilitation in COPD Patients

NCT ID: NCT04816825

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-23
• Study Completion Date: 2025-12-30

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

Conditions

Copd

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Alkit eSence

Intervention Type: DEVICE

Home-based rehabilitation program including computer games and supervised by a physiotherapist.

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.

Group Type: ACTIVE_COMPARATOR

Standard rehabilitation

Intervention Type: OTHER

Standard rehabilitation program at the COPD-Center

Interventions

Alkit eSence

Home-based rehabilitation program including computer games and supervised by a physiotherapist.

Intervention Type: DEVICE

Standard rehabilitation

Standard rehabilitation program at the COPD-Center

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

COPD-Center

Gothenburg, VGR, Sweden

Countries

Sweden

Other Identifiers

ExerGaming

Identifier Type: -

Identifier Source: org_study_id