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Evidence Based Training and Physical Activity With an E-health Program

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03634553
Enrollment
80
Registered
2018-08-16
Start date
2021-01-01
Completion date
2023-12-31
Last updated
2020-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Implementation, Physical Activity

Brief 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). 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.

Interventions

OTHERTraining 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.

OTHERUsual care

usual care, i.e. participates in regular training regime at the physiotherapy department

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* medical barriers to participate in training at home with the e-health program.

Design outcomes

Primary

MeasureTime frameDescription
COPD Assessment Test, CAT, to assess symtoms of COPDAssess change from baseline to 10 weeks, 6 month and 12 month follow-upQuestionnaire with 8 questions, graded 0-5. Total sum range from 0-40. High scores indicate high prevalence of symtoms.

Secondary

MeasureTime frameDescription
Leicester Cough Questionnaire LCQ-S assess health-related quality of life related to coughAssess change from baseline to 10 weeks, 6 month and 12 month follow-upQuestionnaire 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
mMRC (Medical Research Council Scale) assess symtoms of COPDAssess change from baseline to 10 weeks, 6 month and 12 month follow-upOne scale ranging from 0-4, 4 indicate severe symtoms.
the Hospital anxiety and depression Scale, HAD, assess anxiety and depressionAssess change from baseline to 10 weeks, 6 month and 12 month follow-upQuestionnaire 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.
The SCI Exercise Self-Efficacy Scale assess Self-efficacy of their own ability to cope with physical activitiesAssess change from baseline to 10 weeks, 6 month and 12 month follow-upQuestionnaire with 10 questions, graded 1-4. Total score of 10-40, higher scores indicate higher ability
Frändin Grimby scale to assess Physical activity levelAssess change from baseline to 10 weeks, 6 month and 12 month follow-upOne scale ranging from 1-6, higher score indicate higher physical activity level
Accelerometer to assess physical activity level and patternAssess change from baseline to 10 weeks, 6 month and 12 month follow-upAccelerometer that assess different parameters related to physical activity pattern and level. Data collection during 5 days.
EuroQoL (EQ5D) assess health-related quality of lifeAssess change from baseline to 10 weeks, 6 month and 12 month follow-upQuestionnaire 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.
The Activities-specific Balance Confidence scale (ABC scale) assess balance confidenceAssess change from baseline to 10 weeks, 6 month and 12 month follow-upQuestionnaire with 16 questions, graded 0-10. Total score is calculated by counting up all the 16 questions and thereafter divide by 16.
6-minute walk test to assess physical performanceAssess change from baseline to 10 weeks, 6 month and 12 month follow-upwalk test during 6 minutes. The total length is noted.
Sit to stand test to assess muscle strength in the lower leg.Assess change from baseline to 10 weeks, 6 month and 12 month follow-upNumber of rises from a chair are counted during 30 and 60 seconds.
10 meter walking test to assess walking speed.Assess change from baseline to 10 weeks, 6 month and 12 month follow-upThe walking speed is calculated by taking time while the participant walk 10 meters during preferred and fast speed.
Hand grip test to assess hand grip strengthAssess change from baseline to 10 weeks, 6 month and 12 month follow-upAssess hand grip strength with a hand dynamometer.
Fall efficacy scale international (FES-I) to assess concerns about fallingAssess change from baseline to 10 weeks, 6 month and 12 month follow-upQuestionnaire with 16 questions, graded 1-4. Total score of 16-64. Higher score indicate higher level of concerns.
MiniBESTest asses balance performanceAssess change from baseline to 10 weeks, 6 month and 12 month follow-upMeasurement 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

Contacts

Primary ContactAlexandra Halvarsson, PhD
alexandra.halvarsson@ki.se+46852488810
Backup ContactKirsti Skavberg Roaldsen, PhD
kirsti.skavberg.roaldsen@ki.se+46852488810

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026