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

NCT03634553 | Unknown

• 1 other identifier: 4-1738/2018
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COPD; Physical Activity; Implementation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• EuroQoL (EQ5D) assess health-related quality of life

  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

  Assess change from baseline to 10 weeks, 6 month and 12 month follow-up

• mMRC (Medical Research Council Scale) assess symtoms of COPD

  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

  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

  Assess change from baseline to 10 weeks, 6 month and 12 month follow-up

Study Arms (2)

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.

Other: Training with e-health product

Control

ACTIVE COMPARATOR

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

Other: Usual care

Interventions

Training with e-health product 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.

Intervention

Usual care OTHER

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

Control

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Related Publications (1)

• 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.

  PMID: 33511633 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Alexandra Halvarsson, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Halvarsson, PhD

CONTACT

+46852488810; alexandra.halvarsson@ki.se

Kirsti Skavberg Roaldsen, PhD

CONTACT

+46852488810; kirsti.skavberg.roaldsen@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: August 16, 2018
• Study Start: January 1, 2021
• Primary Completion: January 30, 2022
• Study Completion: December 31, 2023
• Last Updated: September 9, 2020

Record last verified: 2020-09