The Effect of Maximal Strength Training on Lung Function in Patients With COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

The Effect of Maximal Strength Training on Lung Function in Patients With COPD

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05586399
• Other study ID #: NA -COPD
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2022
• Source: Molde University College
• Contact: Norun Aagård, Msc
• Phone: + 99364951
• Email: norun.aagaard[@]treningsklinikken.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect on maximal strength training on muscle function, lung function and quality of life for patients diagnosed with COPD grade II-III (Gold scale). Each patient will complete a total of 20 exercise session participating in a rehabilitation program for 4 weeks. Physiological and functional testing will be performed 4 weeks before the training intervention, at baseline and after the intervention period.

Description:

COPD is a group of diseases which affect the pulmonary system and leads to airflow restrictions and breathing difficulty. Other healthcare related problems, such as chronic inflammation, reduced muscle function, anxiety, depression and cardiovascular diseases are often seen in patients who are diagnosed with COPD.

Frequent participation in physical activity has been shown to improve the general public health, and serve as a prevention for development of various chronic diseases. Physical activity has at the same time been shown to be effective in treatment of both pulmonary and cardiovascular diseases. It also has the potential to reduce the need for health services, and can replace or reduce the need for medicinal treatments.

In this study we are want to investigate the effect of maximal strength training in COPD patients grade II-III on both muscle function and lung function. Maximal strength training (MST) have previously been shown as a superior intervention to achieve increased 1RM and fast development of power, also known as rate of force development (RFD). Lung function in COPD patients has been shown in previous research to be improved following maximal strength training.

The participants will partake in a total of 20 MST interventions during a rehabilitation period of 4 weeks. The sessions will be distributed five times a week located in two different Rehabilitation Centers in Trondheim, Norway. The strength training will be performed in groups, supervised by one or more coworkers in the project. MST will be performed with 4 series of 4 RM in a horizontal leg press machine, supervised by a coworker in the project. As part of the rehabilitation program, participants will also perform endurance training parallell to the MST sessions.

The participants will function as their own control group in the project. They will participate in a pre-test 4 weeks before the intervention period. After the pre-test they will be instructed to live as usual for the next 4 weeks. They will then start the intervention period, with tests performed at start and end of the period.

Both subjective and objective measurements will be performed 4 weeks before, at baseline and after the intervention period. All physiological tests will be completed during the same day. A standardized work economy test on a treadmill will be used in assessment of endurance capacity, with an expected duration of 4 minutes. The work economy test will be followed by a standardized graded test of maximal oxygen consumption, with a maximal duration of 10 minutes. Both endurance tests will be performed on a treadmill, with continuous heart rate monitoring. Approximately 5-10 minutes after finishing the endurance tests, a test of maximal dynamic strength will be performed (1RM test). The test will be performed in a horizontal leg press machine. After three submaximal warm-up sets, the load will be gradually increased until the participant fails to perform the test. Duration of rest periods between sets will be standardized to 3 minutes. Rate of force development will also be assessed, with the use of a force plate in the same horizontal leg press machine. There will also be performed functional tests (6 minute walk test, Timed Up and Go and stair climb test). All participants will also answer standardized questionnaires regarding health related quality of life.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• COPD-diagnosis grade II-III (Gold Classification)

• Patients in one of two rehabilitation centres in Trondheim, Norway.

• Must be able to perform the test procedures walking or running on a treadmill.

• Must participate in at least 18 of the 20 planned training sessions.

Exclusion Criteria:

• Other pulmonary disease than COPD

• Diabetes mellitus or other metabolic diseases

• Use of corticosteroids the last 6 weeks

• Pulmonary infection the last 4 weeks

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Maximal strength training in COPD
Participate in a rehabilitation program for 4 weeks, with exercise 5 times a week. Supervised maximal strength training in a leg press machine for a total of 20 exercise sessions. Patients will participate in rehabilitation in one of two rehabilitations centers in Trondheim, Norway.

Locations

Country	Name	City	State
Norway	My Workout - Medical Rehabilitation Clinic	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Molde University College

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Maximal Strenght	Measured in 1 repetition maximum (kg) in leg press.	4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Primary	Change in Rate of Force Development	Measured in Newton using a force plate	4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Primary	Change in Forced Expiratory Volume (FEV1)	Measured using spirometry as the maximal volume of air (liter) exhaled in the first second of expiration	4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Primary	Change in Peak Expiratory Flow (PEF)	Measured using spirometry as the maximal speed of expiration (Measured as liter/min)	4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Primary	Change in Work Economy	Measured using CPET walking on a treadmill at a standardized speed and incline (Measured as VO2 ml/kg/min)	4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Primary	Change in Maximal Oxygen Consumption	Measured using CPET in maximal test walking until exhaustion(Measured as VO2 ml/kg/min)	4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Primary	Change in Stair Climbing-test	Measured in seconds as the average of two attempts	4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Primary	Change in Timed up and Go-test	Measured in seconds as the average of two attempts	4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Primary	Change in 6 Minutes Walk Test	Measured in meters	4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Secondary	Changes in health-related quality of life - Norwegian RAND36	Questionnaire scoring on a 0-100 scale with higher scores identifying better outcomes	4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Secondary	Changes in health-related quality of life - Hospital and Anxiety Score (HADS)	Questionnaires - Change in total score from 0-21 where higher score may indicate anxiety and/or depression	4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Secondary	Changes in health-related quality of life - International physical activity questionnaire (IPAQ)	Questionnaires - Change in MET-minutes of physical acitivity a week with higher score identifying better outcomes	4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Secondary	Changes in health-related quality of life - EQ-5D-5L	Questionnaires - Change in health state from level 1-5 with lower level identifying better outcomes	4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Secondary	Changes in health-related quality of life - Visual Analogue Scale (VAS)	Questionnaires - Units on a Scale from 0-10 cm with lower score identifying better outcomes	4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.