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

NCT ID: NCT03634553

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-12-31

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.

Conditions

COPD; Physical Activity; Implementation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Training with e-health product

Intervention Type: OTHER

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

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

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Usual care

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Alexandra Halvarsson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandra Halvarsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Central Contacts

Alexandra Halvarsson, PhD

Role: CONTACT

alexandra.halvarsson@ki.se

+46852488810

Kirsti Skavberg Roaldsen, PhD

Role: CONTACT

kirsti.skavberg.roaldsen@ki.se

+46852488810

References

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.

Reference Type: DERIVED

PMID: 33511633 (View on PubMed)

Other Identifiers

4-1738/2018

Identifier Type: -

Identifier Source: org_study_id