An interventional study of Maximal strength training in COPD in Chronic Obstructive Pulmonary Disease, sponsored by Molde University College. Status unknown at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-19.
Sponsored by Molde University College · Not applicable, Interventional, and Treatment
Among 99 studies in Pulmonary Disease, Chronic Obstructive with a site in Norway — 6 open to participants now, 7 under way, 3 of them phase 3. Pulmonary Disease, Chronic Obstructive · Norway.
Among the 99 studies in Pulmonary Disease, Chronic Obstructive with a site in Norway, this one is the 67th largest by planned enrollment of the 79 interventional ones, is one of 2 that started in 2022, is one of 33 with no phase, and was the 91st registered.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 30 is below the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →6 of the 99 studies in Pulmonary Disease, Chronic Obstructive with a site in Norway are open now, in 12 countries. Each count lists the studies.
Of the 555 Pulmonary Disease, Chronic Obstructive studies recruiting now, 305 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 87 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →99 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 2 started in 2022.
Median enrollment 228 across the 79 interventional studies, 200 across the 20 observational. Of the 87 that completed or were terminated, 36 (41%) have results posted.
52 of 99 have an industry lead sponsor. The 10 most frequent:
Molde University College is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Molde University College has 1 study filed under Pulmonary Disease, Chronic Obstructive — fewer than ten, so there is no comparison to draw.
1 of the studies in Pulmonary Disease, Chronic Obstructive with a site in Norway that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06401512Western Norway University of Applied SciencesDigital Follow-up Program for People with Chronic Obstructive Pulmonary Disease in Primary Healthcare | 2026-12 |
Among the 99 studies in Pulmonary Disease, Chronic Obstructive with a site in Norway, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Change in Maximal Strenght
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.
Change in Rate of Force Development
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.
Change in Forced Expiratory Volume (FEV1)
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.
Change in Peak Expiratory Flow (PEF)
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.
Change in Work Economy
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.
Change in Maximal Oxygen Consumption
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.
Change in Stair Climbing-test
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.
Change in Timed up and Go-test
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.
Change in 6 Minutes Walk Test
Measured in meters
Time frame: 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 - Norwegian RAND36
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.
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Start is estimated for Nov 2022; primary completion for Jun 2024, 19 months later.
Of 1,094 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 19 months is below that.
Counting every sponsor, half of 1,181 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
Molde University College