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

NCT05586399 | Unknown

• 1 other identifier: NA -COPD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Strength training; Lung function; Quality of life

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (5)

• Changes in health-related quality of life - Norwegian RAND36

  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)

  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)

  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

  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)

  4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.

Study Arms (1)

Exercise intervention

EXPERIMENTAL

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

Interventions

Maximal strength training in COPD BEHAVIORAL

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.

Exercise intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Other pulmonary disease than COPD
• Diabetes mellitus or other metabolic diseases
• Use of corticosteroids the last 6 weeks
• Pulmonary infection the last 4 weeks

Sponsors & Collaborators

• Molde University College: lead

Study Sites (1)

My Workout - Medical Rehabilitation Clinic

Trondheim, 7047, Norway

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 Officials

• Jan Helgerud, PhD

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Norun Aagård, Msc

CONTACT

+ 99364951; norun.aagaard@treningsklinikken.no

Jan Helgerud, PhD

CONTACT

jan.helgerud@ntnu.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre-test 4 weeks before the intervention period (Subjects functioning as their own control), tests at baseline and 4 weeks after the intervention period.

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: October 19, 2022
• Study Start: November 15, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 19, 2022

Record last verified: 2022-09

Locations

NO (1)