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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Physical Activity; COPD; Implementation
• Intervention / Treatment: Other: Training with e-health product; Other: Usual care

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandra Halvarsson, PhD; Phone Number: +46852488810; Email: alexandra.halvarsson@ki.se
• Study Contact Backup: Name: Kirsti Skavberg Roaldsen, PhD; Phone Number: +46852488810; Email: kirsti.skavberg.roaldsen@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Active Comparator: Control; usual care, i.e. participates in regular training regime at the physiotherapy department	Other: Usual care; usual care, i.e. participates in regular training regime at the physiotherapy department

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Assess change from baseline to 10 weeks, 6 month and 12 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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.	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	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	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.	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	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.	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.	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.	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.	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.	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.	Assess change from baseline to 10 weeks, 6 month and 12 month follow-up

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Alexandra Halvarsson, PhD, Karolinska Institutet

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): January 30, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: June 21, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 4-1738/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No