CopdNCT04816825
Home-monitored Telerehabilitation in COPD Patients
A study testing Alkit eSence and Standard rehabilitation in people with Copd, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Copd
- What is being tested?
- Alkit eSence and Standard rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSweden
- Study dates
- 23 Mar 2021to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willingness to participate and signed informed consent form
- Diagnosis of COPD
- FEV1/FVC (post bronchodilator) <0.7
- GOLD severity grade B/D
- FEV, < 80% predicted
- Cognitive ability relevant for the studies as judged by the investigator
- Living in their own home and able to manage their activities of daily living
Who cannot join
- Rapidly progressing severe disease other than COPD and COPD-related diseases.
- 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.
- Inability to communicate in Swedish.
- Any condition that may interfere with the possibility for the subject to comply with the study protocol.
- Already participating in the pulmonary rehabilitation training group 2 times a week.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Effectiveness of a Home Monitored Rehabilitation Intervention Using an Exergaming Approach in COPD Patients - a Randomized, Controlled Clinical Study
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.
Read more
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
- Conditions
- Copd
- Being tested
- Alkit eSence, Standard rehabilitation
- Keywords
- COPD, Telerehabilitation, Pulmonary rehabilitation, exergaming
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alkit eSenceDevice
Home-based rehabilitation program including computer games and supervised by a physiotherapist.
Standard rehabilitationOther
Standard rehabilitation program at the COPD-Center
| Study group | Role | What they receive |
|---|---|---|
| Exergaming | Experimental | 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. Receives: Device: Alkit eSence |
| Standard rehabilitation | Active comparator | 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. Receives: Other: Standard rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Change in level of physical activity will be objectively measured with 1-minute sit to stand test
Measured: Baseline and 12 weeks after baseline
Secondary outcomes (12)
Exercise capacity
Change in submaximal exercise capacity will be measured by 6-Minute Walking Test.
Measured: Baseline and 12 weeks after baseline
Exercise capacity
Change in submaximal exercise capacity will be measured by Timed up and go (TUG) test.
Measured: Baseline and 12 weeks after baseline
Exercise capacity
Change in submaximal exercise capacity will be assessed by outcomes of a pedometer (number of daily steps).
Measured: Baseline and 12 weeks after baseline
Body composition
Change in body composition will be calculated by Body Mass Index (BMI) by a BIA device.
Measured: Baseline and 12 weeks after baseline
Body composition
Change in body composition will be calculated by Fat Free Mass Index (FFMI) by a BIA device.
Measured: Baseline and 12 weeks after baseline
Body strength
Change in quadriceps muscle strength measured by the One-Repetition Maximum test (1RM). Muscle endurance will be measured by a shoulder flexion test (SFT).
Measured: Baseline and 12 weeks after baseline
Body strength
Change in muscle endurance will be measured by a shoulder flexion test (SFT).
Measured: Baseline and 12 weeks after baseline
Health-related quality of life
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.
Measured: Baseline and 12 weeks after baseline
Health-related quality of life
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.
Measured: Baseline and 12 weeks after baseline
Number of exacerbations
Change in exacerbation incidence will be measured by number of courses of corticosteroids and/or antibiotics for a worsening of respiratory symptoms.
Measured: Baseline and 12 weeks after baseline
Healthcare utilization
Change in healthcare utilization will be measured by number of hospital admissions for COPD.
Measured: Baseline and 12 weeks after baseline
Healthcare utilization
Change in healthcare utilization will be measured by number of hospital admissions for all causes.
Measured: Baseline and 12 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start23 Mar 2021
- Primary completion31 Dec 2024
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized clinical controlled study
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816825
- Sponsor's protocol ID
- ExerGaming
- Status last verified
- May 2026
- First submitted
- 18 Mar 2021
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of a Home Monitored Rehabilitation Intervention Using an Exergaming Approach in COPD Patients - a Randomized, Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04816825
- Acronym / sponsor ID
- ExerGaming
- Conditions
- Copd
- Keywords
- COPD, Telerehabilitation, Pulmonary rehabilitation, exergaming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized clinical controlled study
| Arm | Type | Receives |
|---|---|---|
| Exergaming | Experimental | Device: Alkit eSenceThe 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. |
| Standard rehabilitation | Active comparator | Other: Standard rehabilitationStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willingness to participate and signed informed consent form
- Diagnosis of COPD
- FEV1/FVC (post bronchodilator) <0.7
- GOLD severity grade B/D
- FEV, < 80% predicted
Key exclusion criteria (5 listed)
- Rapidly progressing severe disease other than COPD and COPD-related diseases.
- 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.
- Inability to communicate in Swedish.
- Any condition that may interfere with the possibility for the subject to comply with the study protocol.
- Already participating in the pulmonary rehabilitation training group 2 times a week.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alkit eSenceHome-based rehabilitation program including computer games and supervised by a physiotherapist. | Device | Exergaming |
| Standard rehabilitationStandard rehabilitation program at the COPD-Center | Other | Standard rehabilitation |
Primary outcome
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
12 secondary outcomes
Exercise capacity
Time frame: Baseline and 12 weeks after baseline
Exercise capacity
Time frame: Baseline and 12 weeks after baseline
Exercise capacity
Time frame: Baseline and 12 weeks after baseline
Body composition
Time frame: Baseline and 12 weeks after baseline
Body composition
Time frame: Baseline and 12 weeks after baseline
Body strength
Time frame: Baseline and 12 weeks after baseline
Body strength
Time frame: Baseline and 12 weeks after baseline
Health-related quality of life
Time frame: Baseline and 12 weeks after baseline
Health-related quality of life
Time frame: Baseline and 12 weeks after baseline
Number of exacerbations
Time frame: Baseline and 12 weeks after baseline
Healthcare utilization
Time frame: Baseline and 12 weeks after baseline
Healthcare utilization
Time frame: Baseline and 12 weeks after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alkit eSence and Standard rehabilitation in people with Copd, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: Baseline and 12 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.