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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Maximal strength training in COPD
Sponsored by
Molde University College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Strength training, Lung function, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • My Workout - Medical Rehabilitation Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Maximal Strenght
Measured in 1 repetition maximum (kg) in leg press.
Change in Rate of Force Development
Measured in Newton using a force plate
Change in Forced Expiratory Volume (FEV1)
Measured using spirometry as the maximal volume of air (liter) exhaled in the first second of expiration
Change in Peak Expiratory Flow (PEF)
Measured using spirometry as the maximal speed of expiration (Measured as liter/min)
Change in Work Economy
Measured using CPET walking on a treadmill at a standardized speed and incline (Measured as VO2 ml/kg/min)
Change in Maximal Oxygen Consumption
Measured using CPET in maximal test walking until exhaustion(Measured as VO2 ml/kg/min)
Change in Stair Climbing-test
Measured in seconds as the average of two attempts
Change in Timed up and Go-test
Measured in seconds as the average of two attempts
Change in 6 Minutes Walk Test
Measured in meters

Secondary Outcome Measures

Changes in health-related quality of life - Norwegian RAND36
Questionnaire scoring on a 0-100 scale with higher scores identifying better outcomes
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
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
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
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

Full Information

First Posted
September 6, 2022
Last Updated
October 17, 2022
Sponsor
Molde University College
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1. Study Identification

Unique Protocol Identification Number
NCT05586399
Brief Title
The Effect of Maximal Strength Training on Lung Function in Patients With COPD
Official Title
The Effect of Maximal Strength Training on Lung Function in Patients With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2022 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molde University College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Strength training, Lung function, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-test 4 weeks before the intervention period (Subjects functioning as their own control), tests at baseline and 4 weeks after the intervention period.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Norun Aagård, Msc
Phone
+ 99364951
Email
norun.aagaard@treningsklinikken.no
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Helgerud, PhD
Email
jan.helgerud@ntnu.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Helgerud, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
My Workout - Medical Rehabilitation Clinic
City
Trondheim
ZIP/Postal Code
7047
Country
Norway
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norun Aagård, Msc
Phone
47472788
Email
norun.aagaard@treningsklinikken.no
First Name & Middle Initial & Last Name & Degree
Jan Hoff, PhD
Email
janhoff@myworkout.no

12. IPD Sharing Statement

Learn more about this trial

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

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