Chronic Obstructive Pulmonary DiseaseNCT02598830
The Granheim COPD Study - Vitamin D and Strength Training
A study testing Vitamin D3 in people with Chronic Obstructive Pulmonary Disease, run by Inland Norway University of Applied Sciences at 1 site in Norway.
Trial summary
This study evaluates the effect of vitamin D supplementation on outcomes of 10 weeks progressive strength training in 100 ageing subjects (>45 years of age). Participants will be recruited into two similarly sized strata; one containing COPD patients and one containing healthy subjects of similar age. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2015to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stable COPD at GOLD stage II or III, FEV1/FVC < 0.7 and FEV1 <80% and >30% of predicted
- >45 years of age
- >45 years of age
Who cannot join
- Unstable cardiovascular disease
- Chronic granulomatous
- Known active malignant disease within last 5 years
- Physically disabling muscloskeletal diseases
- Peroral use of steroids within last 2 months
- Serious psychiatric comorbidity
Show all 21Show fewer
- Less than 4 weeks since last return t o habit ual condit ion from exacerbation
- Failing to understand Norwegian literary or verbally
- Medical record diagnosis of asthma
- More than one bout of strength training per week during the last 6 months leading up to the project
- Healthy control group
- COPD
- Unstable cardiovascular disease
- Chronic granulomatous
- Known active malignant disease within last 5 years
- Physically disabling muscloskeletal diseases
- Peroral use of steroids within last 2 months
- Serious psychiatric comorbidity
- Failing to understand Norwegian literary or verbally
- Medical record diagnosis of asthma
- More than one bout of strength training per week during the last 6 months leading up to the project
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Granheim COPD Study: Effects of Vitamin D3-supplementation on the Efficacy of Strength Training in COPD Patients and Healthy Controls - a Double-blinded RCT
This study evaluates the effect of vitamin D supplementation on outcomes of 10 weeks progressive strength training in 100 ageing subjects (>45 years of age). Participants will be recruited into two similarly sized strata; one containing COPD patients and one containing healthy subjects of similar age. In each stratum, half the participants will receive vitamin D supplementation and half the participants will receive placebo
Read the detailed description
Physical activity is a potent way of relieving some of the adverse morbidities associated with COPD, such as muscle atrophy and reduced muscle quality. It is thus problematic that 20-30% of patients fail to elicit positive adaptations to training. This oddity has been ascribed inherent muscular properties, with potential links to comorbidities such as vitamin D and testosterone deficiency and the nature of the training program. In the present project, a double-blinded RCT will be performed to disclose the functional and biological efficacy of vitamin D supplementation (with concomitant ingestion of 1000 mg Ca2+) on the outcomes of 10 wks strength training in 100 aging individuals with or without COPD. The strength training intervention will be preceded by 3 weeks of progressive introduction to training protocols.
50 COPD patients and 50 healthy subjects will be allocated into two strata and separately randomized into two equally sized supplementation groups; (1) vitamin D3 and (2) placebo. The planned 50:50 ratio between COPD patients and healthy individuals may change, depending on the access to COPD patients. All subjects will perform lower-limb strength-training protocols in a contralateral manner: (leg 1) high-resistance (10 RM) and (leg 2) low-resistance (30 RM). Such a one-limb-at-a-time protocol ensures training that is unconfined by the cardiorespiratory limitations inherent to these patients, and allow comparison of the two training modalities in a manner unconfined by individual variation in exercise adaptability. A pilot study investigating the possible central pulmonary capacity limitation to two-legged strength training exercise in COPD patients will be performed. In this pilot study, we will compare exercise performance involving large and small muscle mass. In addition, all subjects will perform a selection of bilateral upper body exercises (10 RM), ensuring adequate hormonal responses and compliance to the study. The study is likely to revitalize guidelines for rehabilitation of COPD patients, and to provide vital information regarding the role of vitamin D in adaptations to strength training.
For outcome measures specific to COPD pasients, final analyses will be performed on data from the COPD population only. For other outcome measures, final analyses will be performed on data merged from COPD patients and healthy subjects. An important rationale behind implementing healthy control subjects is to increase the statistical power of outcome measures unrelated to COPD epidemiology, which are of general relevance to physiological adaptation to strength training. In a related set of analyses, we will perform between-groups comparisons, including multivariate analyses. We will also compare the efficacy of high- and low-resistance strength training in COPD patients and healthy control subjects. The two training modalities are expected to result in similar muscular adaptations.
In general, baseline vitamin D levels in blood, measured as 25(OH)D, is anticipated to be a determinant of the efficacy of the strength training intervention. In response to vitamin D3 supplementation, individuals with low baseline levels of 25(OH)D are expected to display more pronounced changes in biological active vitamin D, leading to more pronounced changes in functional and biological outcome measures in response to strength training. In contrast, supplementation may not lead to further elevation of blood 25(OH)D levels in individuals with high baseline levels, essentially meaning that vitamin D3 ingestion will be leveled out by or exceeded by the elimination of vitamin D derivatives. In these individuals, vitamin D3 ingestion will not have an additive effect on functional and biological outcome measures in response to strength training. To assess individual variation in vitamin D responses, data on functional and biological variables will be divided into quartiles based on baseline 25(OH)D-levels, whereupon comparisons will be made between low-end and high-end quartiles. Individual variation in responses to vitamin D supplementation and strength training will also be assessed using a mixed model approach.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Vitamin D3, Placebo
- Keywords
- Cachexia, Vitamin D, Muscle, Strength training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called cholecalciferol
Vitamin D3 dissolved in olive oil, encapsuled
PlaceboDietary supplement
Olive oil, encapsuled
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3+str.training, COPD & Healthy | Experimental | Vitamin D3 capsules for 30 weeks:
* weeks 1-2: 10000 IU/day (equivalent to 250 ug), accompanied by 1000 mg Ca2+
* weeks 3-30: 2000 IU/day (equivalent to 50 ug), accompanied by 1000 mg Ca2+
Progressive unilateral strength training of the legs for 3+10 weeks (weeks 15-28); leg 1 = high-load training, leg 2 = low-load training, allocated to left and right foot in a randomized manner:
* weeks 15-17, familiarization period
* week 18, test period
* weeks 19-28, intervention period
* weeks 29-30, test period Receives: Dietary Supplement: Vitamin D3 |
| Placebo+str.training, COPD & Healthy | Placebo comparator | Placebo capsules for 30 weeks (the number of capsules ingested each day match those of the vitamin D3 group)
Progressive unilateral strength training of the legs for 3+10 weeks (weeks 15-28); leg 1 = high-load training, leg 2 = low-load training, allocated to left and right foot in a randomized manner:
* weeks 15-17, familiarization period
* week 18, test period
* weeks 19-28, intervention period
* weeks 29-30, test period Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle size
Muscle cell cross-sectional area measured in biopsies from m. vastus lateralis using immunohistochemistry
Measured: Changes from before to after the strength training intervention (week 19 to week 28)
Muscle phenotype
Muscle fiber type composition measured in biopsies from m. vastus lateralis using immunohistochemistry
Measured: Changes from before to after the strength training intervention (week 19 to week 28)
Secondary outcomes (26)
Lung function
Lung function measured using spirometry
Measured: Changes from before to after the strength training intervention (week 19 to week 28)
One-legged cycling
Performance indicies measured during an incremental one-legged cycling test
Measured: Changes from before to after the strength training intervention (week 19 to week 28)
Hormones in blood
Levels of hormones in blood
Measured: Changes over the course of the intervention (week 0 to 28)
Cytokines in blood
Levels of cytokines in blood
Measured: Changes over the course of the intervention (week 0 to 28)
Steroids in skeletal muscle
Levels of steroids in m. vastus lateralis
Measured: Changes over the course of the intervention (week 0 to 28)
Androgen-converting enzymes in skeletal muscle
Levels of androgen-converting enzymes in m. vastus lateralis
Measured: Changes from before to after the strength training intervention (week 19 to week 28)
Gene expression in skeletal muscle
RNA (e.g. messenger RNA, ribosomal RNA, microRNA, long non-coding RNA) abundances in m. vastus lateralis, measured both as single genes and at the level of the transcriptome
Measured: Changes from before to after the strength training intervention (week 19 to week 28)
Gene expression in skeletal muscle
RNA (e.g. messenger RNA, ribosomal RNA, microRNA, long non-coding RNA) abundances in m. vastus lateralis, measured both as single genes and at the level of the transcriptome
Measured: Changes from before to after familiarization to strength training (week 15 to week 17)
Protein abundances in skeletal muscle
Levels of proteins and their modification status (e.g. phosphorylation) in m. vastus lateralis, measured at the level of single proteins and at the level of the proteome
Measured: Changes from before to after the strength training intervention (week 19 to week 28)
Protein abundances in skeletal muscle
Levels of proteins and their modification status (e.g. phosphorylation) in m. vastus lateralis, measured at the level of single proteins and at the level of the proteome
Measured: Changes from before to after familiarization to strength training (week 15 to week 17)
Vitamin D in blood
Levels of vitamin D in blood
Measured: Changes over the course of the intervention (week 0 to 28)
Step test
Performance and performance indicies measured during a 6 minutes step test
Measured: Changes from before to after the strength training intervention (week 19 to week 28)
Pasient-reported outcome measures, generic
Pasient-related outcome measures assessed using the generic survey SF-36
Measured: Changes from before to after the strength training intervention (week 19 to week 28)
Pasient-reported outcome measures, COPD-specific
COPD-specific pasient-reported outcome assessed using COPD assessment test
Measured: Changes from before to after the strength training intervention (week 19 to week 28)
Body mass composition
Body mass composition measured using Dual-energy X-ray absorptiometry (DXA)
Measured: Changes from before to after the strength training intervention (week 19 to week 28)
Bilateral upper body maximal strength
The ability of muscles of the upper body to exert maximal force during dynamic movements
Measured: Changes from before to after the strength training intervention (week 19 to week 28)
Grip strength
Isometric hand grip strength
Measured: Changes from before to after the strength training intervention (week 19 to week 28)
Sit-to-stand test
Performance and performance indicies measured during a sit-to-stand test
Measured: Changes from before to after the strength training intervention (week 19 to week 28)
Unilateral lower body maximal muscle strength
The ability of muscles of the lower body to exert maximal force during dynamic movements
Measured: Changes from before to after the strength training intervention (week 19 to week 28)
Unilateral lower body muscle endurance
The ability of muscles of the lower body to perform repeated dynamic contractions at a specified submaximal load to exhaustion
Measured: Changes from before to after the strength training intervention (week 19 to week 28)
Bilateral upper body muscle endurance
The ability of muscles of the upper body to perform repeated dynamic contractions at a specified submaximal load to exhaustion
Measured: Changes from before to after the strength training intervention (week 19 to week 28)
Unilateral lower body isokinetic muscle strength
The ability of muscles of the lower body to exert maximal force during isokinetic movements
Measured: Changes from before to after the strength training intervention (week 19 to week 28)
Daily life activity level
Daily life activity level measured using accelerometer
Measured: Changes from before to after the intervention (week 0 to week 28)
Muscle cell biological traits
Muscle cell biological traits, including numbers of myonuclei, satelitte cells and capillaries, measured in biopsies from m. vastus lateralis using immunohistochemistry
Measured: Changes from before to after the strength training intervention (week 19 to week 28)
Muscle mitochondrial quantities
Mitochondrial quantities measured in biopsies from m. vastus lateralis
Measured: Changes from before to after the strength training intervention (week 19 to week 28)
Muscle mitochondrial functions
Mitochondrial functions measured in biopsies from m. vastus lateralis
Measured: Changes from before to after the strength training intervention (week 19 to week 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inland Norway University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Sykehuset Innlandet HF, Lillehammer Hospital for Rheumatic Diseases, University of Bergen, University of Copenhagen, Norwegian School of Sport Sciences
- Responsible party
- Sponsor
- Investigators
- Knut Sindre Mølmen, MSc, Principal investigator, Inland Norway University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598830
- Sponsor's protocol ID
- Trainsome 2014#004
- Status last verified
- Dec 2018
- First submitted
- 5 Nov 2015
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified data will be made available to the academic community through the general biobank "The Trainsome - effects of exercise and environment on human cells" (REK-2013/2045, Regional Comitees for Medical and Health Research Ethics South East). Data will be available on request and will be restricted to scientists and/or projects with a sound scientific purpose and rationale.
Publications
Molmen KS, Hammarstrom D, Falch GS, Grundtvig M, Koll L, Hanestadhaugen M, Khan Y, Ahmad R, Malerbakken B, Rodolen TJ, Lien R, Ronnestad BR, Raastad T, Ellefsen S. Chronic obstructive pulmonary disease does not impair responses to resistance training. J Transl Med. 2021 Jul 6;19(1):292. doi: 10.1186/s12967-021-02969-1.
PubMed 34229714
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Granheim COPD Study: Effects of Vitamin D3-supplementation on the Efficacy of Strength Training in COPD Patients and Healthy Controls - a Double-blinded RCT
- ClinicalTrials.gov ID
- NCT02598830
- Acronym / sponsor ID
- Trainsome 2014#004
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Cachexia, Vitamin D, Muscle, Strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Inland Norway University of Applied SciencesUniversity, hospital or other
- Collaborators
- Sykehuset Innlandet HF, Lillehammer Hospital for Rheumatic Diseases, University of Bergen, University of Copenhagen, Norwegian School of Sport Sciences
- Study start
- Nov 2015 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 6 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effect of vitamin D supplementation on outcomes of 10 weeks progressive strength training in 100 ageing subjects (>45 years of age). Participants will be recruited into two similarly sized strata; one containing COPD patients and one containing healthy subjects of similar age. In each stratum, half the participants will receive vitamin D supplementation and half the participants will receive placebo
Detailed description
Physical activity is a potent way of relieving some of the adverse morbidities associated with COPD, such as muscle atrophy and reduced muscle quality. It is thus problematic that 20-30% of patients fail to elicit positive adaptations to training. This oddity has been ascribed inherent muscular properties, with potential links to comorbidities such as vitamin D and testosterone deficiency and the nature of the training program. In the present project, a double-blinded RCT will be performed to disclose the functional and biological efficacy of vitamin D supplementation (with concomitant ingestion of 1000 mg Ca2+) on the outcomes of 10 wks strength training in 100 aging individuals with or without COPD. The strength training intervention will be preceded by 3 weeks of progressive introduction to training protocols.
50 COPD patients and 50 healthy subjects will be allocated into two strata and separately randomized into two equally sized supplementation groups; (1) vitamin D3 and (2) placebo. The planned 50:50 ratio between COPD patients and healthy individuals may change, depending on the access to COPD patients. All subjects will perform lower-limb strength-training protocols in a contralateral manner: (leg 1) high-resistance (10 RM) and (leg 2) low-resistance (30 RM). Such a one-limb-at-a-time protocol ensures training that is unconfined by the cardiorespiratory limitations inherent to these patients, and allow comparison of the two training modalities in a manner unconfined by individual variation in exercise adaptability. A pilot study investigating the possible central pulmonary capacity limitation to two-legged strength training exercise in COPD patients will be performed. In this pilot study, we will compare exercise performance involving large and small muscle mass. In addition, all subjects will perform a selection of bilateral upper body exercises (10 RM), ensuring adequate hormonal responses and compliance to the study. The study is likely to revitalize guidelines for rehabilitation of COPD patients, and to provide vital information regarding the role of vitamin D in adaptations to strength training.
For outcome measures specific to COPD pasients, final analyses will be performed on data from the COPD population only. For other outcome measures, final analyses will be performed on data merged from COPD patients and healthy subjects. An important rationale behind implementing healthy control subjects is to increase the statistical power of outcome measures unrelated to COPD epidemiology, which are of general relevance to physiological adaptation to strength training. In a related set of analyses, we will perform between-groups comparisons, including multivariate analyses. We will also compare the efficacy of high- and low-resistance strength training in COPD patients and healthy control subjects. The two training modalities are expected to result in similar muscular adaptations.
In general, baseline vitamin D levels in blood, measured as 25(OH)D, is anticipated to be a determinant of the efficacy of the strength training intervention. In response to vitamin D3 supplementation, individuals with low baseline levels of 25(OH)D are expected to display more pronounced changes in biological active vitamin D, leading to more pronounced changes in functional and biological outcome measures in response to strength training. In contrast, supplementation may not lead to further elevation of blood 25(OH)D levels in individuals with high baseline levels, essentially meaning that vitamin D3 ingestion will be leveled out by or exceeded by the elimination of vitamin D derivatives. In these individuals, vitamin D3 ingestion will not have an additive effect on functional and biological outcome measures in response to strength training. To assess individual variation in vitamin D responses, data on functional and biological variables will be divided into quartiles based on baseline 25(OH)D-levels, whereupon comparisons will be made between low-end and high-end quartiles. Individual variation in responses to vitamin D supplementation and strength training will also be assessed using a mixed model approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3+str.training, COPD & Healthy | Experimental | Dietary Supplement: Vitamin D3Vitamin D3 capsules for 30 weeks: * weeks 1-2: 10000 IU/day (equivalent to 250 ug), accompanied by 1000 mg Ca2+ * weeks 3-30: 2000 IU/day (equivalent to 50 ug), accompanied by 1000 mg Ca2+ Progressive unilateral strength training of the legs for 3+10 weeks (weeks 15-28); leg 1 = high-load training, leg 2 = low-load training, allocated to left and right foot in a randomized manner: * weeks 15-17, familiarization period * week 18, test period * weeks 19-28, intervention period * weeks 29-30, test period |
| Placebo+str.training, COPD & Healthy | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsules for 30 weeks (the number of capsules ingested each day match those of the vitamin D3 group) Progressive unilateral strength training of the legs for 3+10 weeks (weeks 15-28); leg 1 = high-load training, leg 2 = low-load training, allocated to left and right foot in a randomized manner: * weeks 15-17, familiarization period * week 18, test period * weeks 19-28, intervention period * weeks 29-30, test period |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable COPD at GOLD stage II or III, FEV1/FVC < 0.7 and FEV1 <80% and >30% of predicted
- >45 years of age
- >45 years of age
Key exclusion criteria (21 listed)
- Unstable cardiovascular disease
- Chronic granulomatous
- Known active malignant disease within last 5 years
- Physically disabling muscloskeletal diseases
- Peroral use of steroids within last 2 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Also: cholecalciferolVitamin D3 dissolved in olive oil, encapsuled | Dietary supplement | Vitamin D3+str.training, COPD & Healthy |
| PlaceboOlive oil, encapsuled | Dietary supplement | Placebo+str.training, COPD & Healthy |
Primary outcome
Muscle size
Time frame: Changes from before to after the strength training intervention (week 19 to week 28)
Muscle cell cross-sectional area measured in biopsies from m. vastus lateralis using immunohistochemistry
Muscle phenotype
Time frame: Changes from before to after the strength training intervention (week 19 to week 28)
Muscle fiber type composition measured in biopsies from m. vastus lateralis using immunohistochemistry
26 secondary outcomes
Lung function
Time frame: Changes from before to after the strength training intervention (week 19 to week 28)
One-legged cycling
Time frame: Changes from before to after the strength training intervention (week 19 to week 28)
Hormones in blood
Time frame: Changes over the course of the intervention (week 0 to 28)
Cytokines in blood
Time frame: Changes over the course of the intervention (week 0 to 28)
Steroids in skeletal muscle
Time frame: Changes over the course of the intervention (week 0 to 28)
Androgen-converting enzymes in skeletal muscle
Time frame: Changes from before to after the strength training intervention (week 19 to week 28)
Gene expression in skeletal muscle
Time frame: Changes from before to after the strength training intervention (week 19 to week 28)
Gene expression in skeletal muscle
Time frame: Changes from before to after familiarization to strength training (week 15 to week 17)
Protein abundances in skeletal muscle
Time frame: Changes from before to after the strength training intervention (week 19 to week 28)
Protein abundances in skeletal muscle
Time frame: Changes from before to after familiarization to strength training (week 15 to week 17)
Vitamin D in blood
Time frame: Changes over the course of the intervention (week 0 to 28)
Step test
Time frame: Changes from before to after the strength training intervention (week 19 to week 28)
Pasient-reported outcome measures, generic
Time frame: Changes from before to after the strength training intervention (week 19 to week 28)
Pasient-reported outcome measures, COPD-specific
Time frame: Changes from before to after the strength training intervention (week 19 to week 28)
Body mass composition
Time frame: Changes from before to after the strength training intervention (week 19 to week 28)
Bilateral upper body maximal strength
Time frame: Changes from before to after the strength training intervention (week 19 to week 28)
Grip strength
Time frame: Changes from before to after the strength training intervention (week 19 to week 28)
Sit-to-stand test
Time frame: Changes from before to after the strength training intervention (week 19 to week 28)
Unilateral lower body maximal muscle strength
Time frame: Changes from before to after the strength training intervention (week 19 to week 28)
Unilateral lower body muscle endurance
Time frame: Changes from before to after the strength training intervention (week 19 to week 28)
Bilateral upper body muscle endurance
Time frame: Changes from before to after the strength training intervention (week 19 to week 28)
Unilateral lower body isokinetic muscle strength
Time frame: Changes from before to after the strength training intervention (week 19 to week 28)
Daily life activity level
Time frame: Changes from before to after the intervention (week 0 to week 28)
Muscle cell biological traits
Time frame: Changes from before to after the strength training intervention (week 19 to week 28)
Muscle mitochondrial quantities
Time frame: Changes from before to after the strength training intervention (week 19 to week 28)
Muscle mitochondrial functions
Time frame: Changes from before to after the strength training intervention (week 19 to week 28)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
- Derived from this study: PubMed 34229714Molmen KS, Hammarstrom D, Falch GS, Grundtvig M, Koll L, Hanestadhaugen M, Khan Y, Ahmad R, Malerbakken B, Rodolen TJ, Lien R, Ronnestad BR, Raastad T, Ellefsen S. Chronic obstructive pulmonary disease does not impair responses to resistance training. J Transl Med. 2021 Jul 6;19(1):292. doi: 10.1186/s12967-021-02969-1.
- Individual participant dataSharing planned: Yes. De-identified data will be made available to the academic community through the general biobank "The Trainsome - effects of exercise and environment on human cells" (REK-2013/2045, Regional Comitees for Medical and Health Research Ethics South East). Data will be available on request and will be restricted to scientists and/or projects with a sound scientific purpose and rationale.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Knut Sindre Mølmen, MSc principal investigator
Inland Norway University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Chronic Obstructive Pulmonary Disease, run by Inland Norway University of Applied Sciences at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle size (time frame: Changes from before to after the strength training intervention (week 19 to week 28)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02598830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2018.