Home-monitored Telerehabilitation in COPD Patients

NCT04816825 | Active Not Recruiting

• 1 other identifier: ExerGaming
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

Study title Feasibility and effectiveness of a home monitored rehabilitation intervention using an exergaming approach in COPD patients - a randomized, controlled study. Background and rationale Chronic Obstructive Pulmonary Disease (COPD) is a common chronic disease characterized by persistent airflow limitation caused by significant exposure to noxious particles or gases, particularly cigarette smoking. In Sweden the prevalence of COPD is approximately 8% and the annual estimated cost for society of 9.1 billion SEK. Improving exercise capacity and physical activity levels are important goals in management of patients with COPD and are strong determinants of positive outcomes, including increased quality of life. Major barrier for rehabilitation recommendations is the limited access and adherence to organized center-based exercise programs. Major barriers related to the side of health care organization are budgets and infrastructure and the limitation in time of the programs. From patient's perspective major barriers exist, like distance, and lack of transport to the unit, also in relation to the frequency of the program, which is commonly two times a week. Research question and objectives The primary objective of this study is to investigate whether home-based telemonitored supervised exercise programs using an exergaming approach will be associated to improved physical fitness, measured with the (1-minute sit-to-stand test, 1-MSTST) compared to the ordinary care. The secondary objectives of this study are:

1. 1.To investigate whether a home-based exergaming program is associated with improved health-related quality of life, exercise capacity, physical activity levels and body composition.
2. 2.To investigate if the home-based exergaming program is associated with less exacerbations.
3. 3.To investigate if the home-based exergaming program is associated with improved health care utilization and/or less hospitalization from all causes?

Conditions

Copd

Keywords

COPD; Telerehabilitation; Pulmonary rehabilitation; exergaming

Outcome Measures

Primary Outcomes (1)

• Physical activity

  Change in level of physical activity will be objectively measured with 1-minute sit to stand test

  Baseline and 12 weeks after baseline

Secondary Outcomes (12)

• Exercise capacity

  Baseline and 12 weeks after baseline

• Exercise capacity

  Baseline and 12 weeks after baseline

• Exercise capacity

  Baseline and 12 weeks after baseline

• Body composition

  Baseline and 12 weeks after baseline

• Body composition

  Baseline and 12 weeks after baseline

Other Outcomes (1)

• Performance and safety of the device

  Baseline and 12 weeks after baseline

Study Arms (2)

Exergaming

EXPERIMENTAL

The combination of 1) game-console based exercise programs, 2) specifically designed by professional physiotherapists with focus on subjects with a chronic lung disease and 3) weekly distant monitoring with close supervision by a physiotherapist. Individually prescribed exercise program based on tests of patient's physical fitness.

Device: Alkit eSence

Standard rehabilitation

ACTIVE COMPARATOR

Standard rehabilitation at the COPD-Center. This includes recommendations about physical activity according to the general guidelines, however, individualized after each subject's physical fitness level.

Other: Standard rehabilitation

Interventions

Alkit eSence DEVICE

Home-based rehabilitation program including computer games and supervised by a physiotherapist.

Exergaming

Standard rehabilitation OTHER

Standard rehabilitation program at the COPD-Center

Standard rehabilitation

Eligibility Criteria

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

You may qualify if:

• Willingness to participate and signed informed consent form
• Diagnosis of COPD
• FEV1/FVC (post bronchodilator) \<0.7
• GOLD severity grade B/D
• FEV, \< 80% predicted
• Cognitive ability relevant for the studies as judged by the investigator
• Living in their own home and able to manage their activities of daily living

You may not qualify if:

• Rapidly progressing severe disease other than COPD and COPD-related diseases.
• Influencing the HRQOL during the study time as judged by the investigator, e.g. long-term stay (\>2 weeks) away from home during the study period.
• Inability to communicate in Swedish.
• Any condition that may interfere with the possibility for the subject to comply with the study protocol.
• Already participating in the pulmonary rehabilitation training group 2 times a week.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

COPD-Center

Gothenburg, VGR, 413 45, Sweden

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A randomized clinical controlled study

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 25, 2021
• Study Start: March 23, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 30, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-03

Locations

SE (1)