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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Behavioral: Maximal strength training in COPD

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Norun Aagård, Msc; Phone Number: + 99364951; Email: norun.aagaard@treningsklinikken.no
• Study Contact Backup: Name: Jan Helgerud, PhD; Email: jan.helgerud@ntnu.no

Study Locations

• Norway
  • Trondheim, Norway, 7047
    • My Workout - Medical Rehabilitation Clinic
    • Contact: Norun Aagård, Msc; Phone Number: 47472788; Email: norun.aagaard@treningsklinikken.no
    • Contact: Jan Hoff, PhD; Email: janhoff@myworkout.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Exercise intervention; Participants performing a rehabilitation program for 5 times a week in a total of 4 weeks in one of two rehabilitation centers in Trondheim, Norway. The aim is to perform a total of 20 maximal strength training interventions supervised by one or more health professionals. Maximal strength training will be performed with 4 repetitions and 4 series at 90-95% of one repetition maximum.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Molde University College
• Investigators: Principal Investigator: Jan Helgerud, PhD, Norwegian University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Anticipated): November 15, 2022
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: October 17, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Quality of life; Lung function; Strength training
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: NA -COPD

Drug and device information, study documents

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