Clinical trial NCT03634553: Evidence Based Training and Physical Activity With an E-health Program
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Physical Activity
Implementation
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: COPD Assessment Test, CAT, to assess symtoms of COPD
timeFrame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
Secondary outcomes:
measure: EuroQoL (EQ5D) assess health-related quality of life
timeFrame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
measure: Leicester Cough Questionnaire LCQ-S assess health-related quality of life related to cough
timeFrame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
measure: mMRC (Medical Research Council Scale) assess symtoms of COPD
timeFrame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
measure: the Hospital anxiety and depression Scale, HAD, assess anxiety and depression
timeFrame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
measure: The SCI Exercise Self-Efficacy Scale assess Self-efficacy of their own ability to cope with physical activities
timeFrame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
measure: Frändin Grimby scale to assess Physical activity level
timeFrame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
measure: Accelerometer to assess physical activity level and pattern
timeFrame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
measure: MiniBESTest asses balance performance
timeFrame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
measure: The Activities-specific Balance Confidence scale (ABC scale) assess balance confidence
timeFrame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
measure: 6-minute walk test to assess physical performance
timeFrame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
measure: Sit to stand test to assess muscle strength in the lower leg.
timeFrame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
measure: 10 meter walking test to assess walking speed.
timeFrame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
measure: Hand grip test to assess hand grip strength
timeFrame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
measure: Fall efficacy scale international (FES-I) to assess concerns about falling
timeFrame: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Alexandra Halvarsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.