COPDNCT03634553
Evidence Based Training and Physical Activity With an E-health Program
A study testing Training with e-health product in people with COPD and Physical Activity, run by Karolinska Institutet.
Trial summary
The main aim of the project in this application is two-fold. First we will explore and describe facilitators and barriers for being physically active and perform physical training for people with Chronic Obstructive Pulmonary Disease COPD (Step 1). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Physical Activity, Implementation
- What is being tested?
- Training with e-health product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 31 Dec 2023
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants must have a diagnosed COPD, be over 40 years and have no other medical barriers to participate in training at home with the e-health program.
Who cannot join
- medical barriers to participate in training at home with the e-health program.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evidence Based Training and Physical Activity With an E-health Program - a New Method for People With Chronic Obstructive Pulmonary Disease (COPD) to Become More Physically Active.
The main aim of the project in this application is two-fold. First we will explore and describe facilitators and barriers for being physically active and perform physical training for people with Chronic Obstructive Pulmonary Disease COPD (Step 1). Secondly, with user involvement, we will develop and evaluate a novel e-health program with a training module and an evidence-based educational component, the rEACH-COPD e-health program with the aim to increase the understanding and management of the disease and to facilitate every-day living with COPD (Step 2-3).
According to the guidelines of the Swedish National Board of Health and Welfare (SoS), physiotherapy led exercise is an important part of rehabilitation for people with COPD. The e-health training program will follow evidence-based guidelines, i.e. recommendations from SoS and the American College of Sport Medicine (ACSMS).
Read more
Offering individualized and evidence-based training will increase adherence to training. With regular physical activity and exercise there is a potential to improve health-related quality of life, physical capacity, activity and participation in every day life in people with COPD.
By an improved health, physical function and quality of life a decreased use of health care is expected. Thus, this program may, in the long term, contribute to reduced costs for the society.
Read the detailed description
There is convincing evidence that physical activity and exercise have positive effects on quality of life and health in people with chronic disease and/or disabilities, but training programs do not reach all in need for it. Being able to offer individualized evidence-based training with modern technology (e-health) is an option, that may increase participation in health enhancing physical activity in people with chronic diseases.
The main aim of the project in this application is two-fold. First we will explore and describe facilitators and barriers for being physically active and perform physical training for people with Chronic Obstructive Pulmonary Disease COPD (Step 1). Secondly, with user involvement, we will develop and evaluate a novel e-health program with a training module and an evidence-based educational component, the rEACH-COPD e-health program with the aim to increase the understanding and management of the disease and to facilitate every-day living with COPD (Step 2-3).
Participants will be recruited from both Stockholm and Västerbotten county, university hospitals and primary care.
According to the guidelines of the Swedish National Board of Health and Welfare (SoS), physiotherapy led exercise is an important part of rehabilitation for people with COPD. The e-health training program will follow evidence-based guidelines, i.e. recommendations from SoS and the American College of Sport Medicine (ACSMS).
The e-health program will be developed and launched during 2019 and the participants will be included in the development to make the product feasible for the end users.
This project will contribute to improve health in people with COPD by using new technology.Offering individualized and evidence-based training will increase adherence to training. With regular physical activity and exercise there is a potential to improve health-related quality of life, physical capacity, activity and participation in every day life in people with COPD.
By an improved health, physical function and quality of life a decreased use of health care is expected. Thus, this program may, in the long term, contribute to reduced costs for the society.
Being able to offer training with an e-health program will give more people with COPD the opportunity to be physically active and thereby increase the chance for a better life with a good quality of life, less dependency in everyday life and add life to years and years to life. Physical activity and exercise offers a low-cost alternative with large health related effects which benefits both specific symptoms and general health in persons with COPD.
- Conditions
- COPD, Physical Activity, Implementation
- Being tested
- Training with e-health product, Usual care
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training with e-health productOther
The training program follows the recommendations for training from ACSMS and SoS who states the importance that exercise programs should include muscle strengthening, cardiovascular as wells as balance exercises. Therefore, the training program includes: Strengthening exercises for the upper and lower extremities (number: 5-8 pc. with progression in three levels), daily (5-7 times / week), 30 minutes walks and balance training.
Usual careOther
usual care, i.e. participates in regular training regime at the physiotherapy department
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Training with e-health product The training program follows the recommendations for training from ACSMS and SoS who states the importance that exercise programs should include muscle strengthening, cardiovascular as wells as balance exercises. Therefore, the training program includes: Strengthening exercises for the upper and lower extremities (number: 5-8 pc. with progression in three levels), daily (5-7 times / week), 30 minutes walks and balance training. Receives: Other: Training with e-health product |
| Control | Active comparator | usual care, i.e. participates in regular training regime at the physiotherapy department Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD Assessment Test, CAT, to assess symtoms of COPD
Questionnaire with 8 questions, graded 0-5. Total sum range from 0-40. High scores indicate high prevalence of symtoms.
Measured: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
Secondary outcomes (14)
EuroQoL (EQ5D) assess health-related quality of life
Questionnaire with 5 questions with 3 possible responses. The score are calculated with their own index list. The last question is a question with response option of a visual analog scale.
Measured: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
Leicester Cough Questionnaire LCQ-S assess health-related quality of life related to cough
Questionnaire with 19 questions, graded 1-7. The score can be divided into three domains: physical, psychological and social. The domain sum is calculated by producing the average for each domain. These are then combined to give the total sum, which can vary from 3 to 21. Higher scores indicate better health related quality of life
Measured: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
mMRC (Medical Research Council Scale) assess symtoms of COPD
One scale ranging from 0-4, 4 indicate severe symtoms.
Measured: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
the Hospital anxiety and depression Scale, HAD, assess anxiety and depression
Questionnaire with 14 questions, graded 0-4. Contains of two domains, anxiety and depression. Total score for each domain is calculated and higher scores indicates higher levels of anxiety or depression.
Measured: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
The SCI Exercise Self-Efficacy Scale assess Self-efficacy of their own ability to cope with physical activities
Questionnaire with 10 questions, graded 1-4. Total score of 10-40, higher scores indicate higher ability
Measured: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
Frändin Grimby scale to assess Physical activity level
One scale ranging from 1-6, higher score indicate higher physical activity level
Measured: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
Accelerometer to assess physical activity level and pattern
Accelerometer that assess different parameters related to physical activity pattern and level. Data collection during 5 days.
Measured: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
MiniBESTest asses balance performance
Measurement consisting of 14 items, graded 0-2. The measurement consists of four domains and total score for each domain can be calculated and by sum up the domains a total score is given. Higher score indicate better balance performance
Measured: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
The Activities-specific Balance Confidence scale (ABC scale) assess balance confidence
Questionnaire with 16 questions, graded 0-10. Total score is calculated by counting up all the 16 questions and thereafter divide by 16.
Measured: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
6-minute walk test to assess physical performance
walk test during 6 minutes. The total length is noted.
Measured: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
Sit to stand test to assess muscle strength in the lower leg.
Number of rises from a chair are counted during 30 and 60 seconds.
Measured: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
10 meter walking test to assess walking speed.
The walking speed is calculated by taking time while the participant walk 10 meters during preferred and fast speed.
Measured: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
Hand grip test to assess hand grip strength
Assess hand grip strength with a hand dynamometer.
Measured: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
Fall efficacy scale international (FES-I) to assess concerns about falling
Questionnaire with 16 questions, graded 1-4. Total score of 16-64. Higher score indicate higher level of concerns.
Measured: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start1 Jan 2021 (estimated)
- Primary completion30 Jan 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Halvarsson, Karolinska Institutet
- Investigators
- Alexandra Halvarsson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634553
- Sponsor's protocol ID
- 4-1738/2018
- Status last verified
- Sep 2020
- First submitted
- 21 Jun 2018
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
PubMed 33511633
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence Based Training and Physical Activity With an E-health Program - a New Method for People With Chronic Obstructive Pulmonary Disease (COPD) to Become More Physically Active.
- ClinicalTrials.gov ID
- NCT03634553
- Acronym / sponsor ID
- 4-1738/2018
- Conditions
- COPD, Physical Activity, Implementation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Aug 2018 (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.
The main aim of the project in this application is two-fold. First we will explore and describe facilitators and barriers for being physically active and perform physical training for people with Chronic Obstructive Pulmonary Disease COPD (Step 1). Secondly, with user involvement, we will develop and evaluate a novel e-health program with a training module and an evidence-based educational component, the rEACH-COPD e-health program with the aim to increase the understanding and management of the disease and to facilitate every-day living with COPD (Step 2-3).
According to the guidelines of the Swedish National Board of Health and Welfare (SoS), physiotherapy led exercise is an important part of rehabilitation for people with COPD. The e-health training program will follow evidence-based guidelines, i.e. recommendations from SoS and the American College of Sport Medicine (ACSMS).
Offering individualized and evidence-based training will increase adherence to training. With regular physical activity and exercise there is a potential to improve health-related quality of life, physical capacity, activity and participation in every day life in people with COPD.
By an improved health, physical function and quality of life a decreased use of health care is expected. Thus, this program may, in the long term, contribute to reduced costs for the society.
Detailed description
There is convincing evidence that physical activity and exercise have positive effects on quality of life and health in people with chronic disease and/or disabilities, but training programs do not reach all in need for it. Being able to offer individualized evidence-based training with modern technology (e-health) is an option, that may increase participation in health enhancing physical activity in people with chronic diseases.
The main aim of the project in this application is two-fold. First we will explore and describe facilitators and barriers for being physically active and perform physical training for people with Chronic Obstructive Pulmonary Disease COPD (Step 1). Secondly, with user involvement, we will develop and evaluate a novel e-health program with a training module and an evidence-based educational component, the rEACH-COPD e-health program with the aim to increase the understanding and management of the disease and to facilitate every-day living with COPD (Step 2-3).
Participants will be recruited from both Stockholm and Västerbotten county, university hospitals and primary care.
According to the guidelines of the Swedish National Board of Health and Welfare (SoS), physiotherapy led exercise is an important part of rehabilitation for people with COPD. The e-health training program will follow evidence-based guidelines, i.e. recommendations from SoS and the American College of Sport Medicine (ACSMS).
The e-health program will be developed and launched during 2019 and the participants will be included in the development to make the product feasible for the end users.
This project will contribute to improve health in people with COPD by using new technology.Offering individualized and evidence-based training will increase adherence to training. With regular physical activity and exercise there is a potential to improve health-related quality of life, physical capacity, activity and participation in every day life in people with COPD.
By an improved health, physical function and quality of life a decreased use of health care is expected. Thus, this program may, in the long term, contribute to reduced costs for the society.
Being able to offer training with an e-health program will give more people with COPD the opportunity to be physically active and thereby increase the chance for a better life with a good quality of life, less dependency in everyday life and add life to years and years to life. Physical activity and exercise offers a low-cost alternative with large health related effects which benefits both specific symptoms and general health in persons with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Training with e-health productTraining with e-health product The training program follows the recommendations for training from ACSMS and SoS who states the importance that exercise programs should include muscle strengthening, cardiovascular as wells as balance exercises. Therefore, the training program includes: Strengthening exercises for the upper and lower extremities (number: 5-8 pc. with progression in three levels), daily (5-7 times / week), 30 minutes walks and balance training. |
| Control | Active comparator | Other: Usual careusual care, i.e. participates in regular training regime at the physiotherapy department |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- participants must have a diagnosed COPD, be over 40 years and have no other medical barriers to participate in training at home with the e-health program.
Key exclusion criteria (1 listed)
- medical barriers to participate in training at home with the e-health program.
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 |
|---|---|---|
| Training with e-health productThe training program follows the recommendations for training from ACSMS and SoS who states the importance that exercise programs should include muscle strengthening, cardiovascular as wells as balance exercises. Therefore, the training program includes: Strengthening exercises for the upper and lower extremities (number: 5-8 pc. with progression in three levels), daily (5-7 times / week), 30 minutes walks and balance training. | Other | Intervention |
| Usual careusual care, i.e. participates in regular training regime at the physiotherapy department | Other | Control |
Primary outcome
COPD Assessment Test, CAT, to assess symtoms of COPD
Time frame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
Questionnaire with 8 questions, graded 0-5. Total sum range from 0-40. High scores indicate high prevalence of symtoms.
14 secondary outcomes
EuroQoL (EQ5D) assess health-related quality of life
Time frame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
Leicester Cough Questionnaire LCQ-S assess health-related quality of life related to cough
Time frame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
mMRC (Medical Research Council Scale) assess symtoms of COPD
Time frame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
the Hospital anxiety and depression Scale, HAD, assess anxiety and depression
Time frame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
The SCI Exercise Self-Efficacy Scale assess Self-efficacy of their own ability to cope with physical activities
Time frame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
Frändin Grimby scale to assess Physical activity level
Time frame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
Accelerometer to assess physical activity level and pattern
Time frame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
MiniBESTest asses balance performance
Time frame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
The Activities-specific Balance Confidence scale (ABC scale) assess balance confidence
Time frame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
6-minute walk test to assess physical performance
Time frame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
Sit to stand test to assess muscle strength in the lower leg.
Time frame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
10 meter walking test to assess walking speed.
Time frame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
Hand grip test to assess hand grip strength
Time frame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
Fall efficacy scale international (FES-I) to assess concerns about falling
Time frame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Derived from this study: PubMed 33511633Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
- Individual participant dataSharing planned: Undecided
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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.
Alexandra Halvarsson, PhD principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
A study testing Training with e-health product in people with COPD and Physical Activity, run by Karolinska Institutet.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Halvarsson, PhD (+46852488810, alexandra.halvarsson@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD Assessment Test, CAT, to assess symtoms of COPD (time frame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03634553, which also lists 1 linked publication.
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 9 Sep 2020.