Home-monitored Telerehabilitation in COPD Patients

Copd Clinical Trial

Official title:

Feasibility and Effectiveness of a Home Monitored Rehabilitation Intervention Using an Exergaming Approach in COPD Patients - a Randomized, Controlled Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04816825
• Other study ID #: ExerGaming
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Vastra Gotaland Region
• Contact: Lowie Vanfleteren
• Phone: 0046736601730
• Email: lowie.vanfleteren[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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. To investigate if the home-based exergaming program is associated with less exacerbations.

3. To investigate if the home-based exergaming program is associated with improved health care utilization and/or less hospitalization from all causes?

Study design This is an open label , randomized controlled clinical study. The study takes place at the COPD-center at Sahlgrenska University hospital. Subjects will be randomized to either the use of the ALKIT exergaming tool in combination with telemonitored supervision by a physiotherapist or ordinary care without this system at their first visit. A total of 92 subjects will be included in the study, 46 in every arm. The intervention will include exergames performed 3 times a week for 12 weeks, consistent with the current recommendations. Pre-and post-intervention tests will be performed and subjects in both groups will be assessed. The tests include: 1-minute sit-to-stand test, 6-minute walk test, and timed-up and go. Two self- assessed questionnaires will be filled in: COPD Assessment Test and EQ5D-5L. Subjects will be also measured for quadriceps muscle strength, shoulder flexion and body composition. Additionally, physical activity level will be assessed by outcomes of pedometer worn over a week. Moreover, exacerbations and health care utilization will be measured. Users' perception of the exergaming program will be also investigated.

Population and study size The study will include a total of 92 subjects, 46 in the intervention- and 46 in the control arm. For each participant, the total study participation time will be 12 weeks. A randomization list will be produced with random assignment of treatment groups in a ratio of 1:1

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Willingness to participate and signed informed consent form

2. Diagnosis of COPD

3. FEV1/FVC (post bronchodilator) <0.7

4. GOLD severity grade B/D

5. FEV, < 80% predicted

6. Cognitive ability relevant for the studies as judged by the investigator

7. Living in their own home and able to manage their activities of daily living

Exclusion Criteria:

1. Rapidly progressing severe disease other than COPD and COPD-related diseases.

2. 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.

3. Inability to communicate in Swedish.

4. Any condition that may interfere with the possibility for the subject to comply with the study protocol.

5. Already participating in the pulmonary rehabilitation training group 2 times a week.

Related Conditions & MeSH terms

• Copd

Intervention

Device:
• Alkit eSence
Home-based rehabilitation program including computer games and supervised by a physiotherapist.

Other:
• Standard rehabilitation
Standard rehabilitation program at the COPD-Center

Locations

Country	Name	City	State
Sweden	COPD-Center	Gothenburg	VGR

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Performance and safety of the device	Users' perception of the exergaming program will be investigated by qualitative methods using short interviews or a self-made questionnaire. A total of 16 questions evaluate the rehabilitation with exergaming strategy and answers are assessed with Visual Analog Score (VAS), 0- strongly disagree, 5-strongry agree. The final score range from 0-80, where 80 indicates more positive feedback.	Baseline and 12 weeks after baseline
Primary	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	Exercise capacity	Change in submaximal exercise capacity will be measured by 6-Minute Walking Test.	Baseline and 12 weeks after baseline
Secondary	Exercise capacity	Change in submaximal exercise capacity will be measured by Timed up and go (TUG) test.	Baseline and 12 weeks after baseline
Secondary	Exercise capacity	Change in submaximal exercise capacity will be assessed by outcomes of a pedometer (number of daily steps).	Baseline and 12 weeks after baseline
Secondary	Body composition	Change in body composition will be calculated by Body Mass Index (BMI) by a BIA device.	Baseline and 12 weeks after baseline
Secondary	Body composition	Change in body composition will be calculated by Fat Free Mass Index (FFMI) by a BIA device.	Baseline and 12 weeks after baseline
Secondary	Body strength	Change in quadriceps muscle strength measured by the One-Repetition Maximum test (1RM). Muscle endurance will be measured by a shoulder flexion test (SFT).	Baseline and 12 weeks after baseline
Secondary	Body strength	Change in muscle endurance will be measured by a shoulder flexion test (SFT).	Baseline and 12 weeks after baseline
Secondary	Health-related quality of life	Change in disease-specific quality of life by using a COPD Assessment Test (CAT) questionnaire. CAT measures COPD symptoms with scores from 0 to 5 points (0 indicating no impact or symptoms, 5- worst possible impact or symptoms) summing up to a total CAT score range of 0-40 points.	Baseline and 12 weeks after baseline
Secondary	Health-related quality of life	Change in general health-related quality of life will be measured by The 5-level EQ-5D EuroQoL (EQ5D-5L) questionnaire. First part of the questionnaire indicates health state in 5 dimentions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The total score ranges 5-25 and higher score indicates worse health condition. The second part of EQ5D-5L, the EQ VAS (Visual Analog Score) records the patient's self-rated health on a vertical visual analogue scale (0-100), where the endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0). This part will be used as a quantitative measure of health outcome that reflect the patient's own judgement.	Baseline and 12 weeks after baseline
Secondary	Number of exacerbations	Change in exacerbation incidence will be measured by number of courses of corticosteroids and/or antibiotics for a worsening of respiratory symptoms.	Baseline and 12 weeks after baseline
Secondary	Healthcare utilization	Change in healthcare utilization will be measured by number of hospital admissions for COPD.	Baseline and 12 weeks after baseline
Secondary	Healthcare utilization	Change in healthcare utilization will be measured by number of hospital admissions for all causes.	Baseline and 12 weeks after baseline