- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02598830
The Granheim COPD Study - Vitamin D and Strength Training
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Lillehammer, Norway
- Inland Norway University of Applied Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
COPD group
Inclusion Criteria:
- Stable COPD at GOLD stage II or III, FEV1/FVC < 0.7 and FEV1 <80% and >30% of predicted
- >45 years of age
Exclusion Criteria:
- 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
- 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
Inclusion Criteria:
- >45 years of age
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vitamin D3+str.training, COPD & Healthy
Vitamin D3 capsules for 30 weeks:
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:
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Vitamin D3 dissolved in olive oil, encapsuled
Other Names:
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Placebo Comparator: Placebo+str.training, COPD & Healthy
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:
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Olive oil, encapsuled
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle size
Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)
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Muscle cell cross-sectional area measured in biopsies from m. vastus lateralis using immunohistochemistry
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Changes from before to after the strength training intervention (week 19 to week 28)
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Muscle phenotype
Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)
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Muscle fiber type composition measured in biopsies from m. vastus lateralis using immunohistochemistry
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Changes from before to after the strength training intervention (week 19 to week 28)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung function
Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)
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Lung function measured using spirometry
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Changes from before to after the strength training intervention (week 19 to week 28)
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One-legged cycling
Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)
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Performance indicies measured during an incremental one-legged cycling test
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Changes from before to after the strength training intervention (week 19 to week 28)
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Hormones in blood
Time Frame: Changes over the course of the intervention (week 0 to 28)
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Levels of hormones in blood
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Changes over the course of the intervention (week 0 to 28)
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Cytokines in blood
Time Frame: Changes over the course of the intervention (week 0 to 28)
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Levels of cytokines in blood
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Changes over the course of the intervention (week 0 to 28)
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Steroids in skeletal muscle
Time Frame: Changes over the course of the intervention (week 0 to 28)
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Levels of steroids in m. vastus lateralis
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Changes over the course of the intervention (week 0 to 28)
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Androgen-converting enzymes in skeletal muscle
Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)
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Levels of androgen-converting enzymes in m. vastus lateralis
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Changes from before to after the strength training intervention (week 19 to week 28)
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Gene expression in skeletal muscle
Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)
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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
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Changes from before to after the strength training intervention (week 19 to week 28)
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Gene expression in skeletal muscle
Time Frame: Changes from before to after familiarization to strength training (week 15 to week 17)
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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
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Changes from before to after familiarization to strength training (week 15 to week 17)
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Protein abundances in skeletal muscle
Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)
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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
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Changes from before to after the strength training intervention (week 19 to week 28)
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Protein abundances in skeletal muscle
Time Frame: Changes from before to after familiarization to strength training (week 15 to week 17)
|
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
|
Changes from before to after familiarization to strength training (week 15 to week 17)
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Vitamin D in blood
Time Frame: Changes over the course of the intervention (week 0 to 28)
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Levels of vitamin D in blood
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Changes over the course of the intervention (week 0 to 28)
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Step test
Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)
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Performance and performance indicies measured during a 6 minutes step test
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Changes from before to after the strength training intervention (week 19 to week 28)
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Pasient-reported outcome measures, generic
Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)
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Pasient-related outcome measures assessed using the generic survey SF-36
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Changes from before to after the strength training intervention (week 19 to week 28)
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Pasient-reported outcome measures, COPD-specific
Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)
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COPD-specific pasient-reported outcome assessed using COPD assessment test
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Changes from before to after the strength training intervention (week 19 to week 28)
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Body mass composition
Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)
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Body mass composition measured using Dual-energy X-ray absorptiometry (DXA)
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Changes from before to after the strength training intervention (week 19 to week 28)
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Bilateral upper body maximal strength
Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)
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The ability of muscles of the upper body to exert maximal force during dynamic movements
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Changes from before to after the strength training intervention (week 19 to week 28)
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Grip strength
Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)
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Isometric hand grip strength
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Changes from before to after the strength training intervention (week 19 to week 28)
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Sit-to-stand test
Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)
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Performance and performance indicies measured during a sit-to-stand test
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Changes from before to after the strength training intervention (week 19 to week 28)
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Unilateral lower body maximal muscle strength
Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)
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The ability of muscles of the lower body to exert maximal force during dynamic movements
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Changes from before to after the strength training intervention (week 19 to week 28)
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Unilateral lower body muscle endurance
Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)
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The ability of muscles of the lower body to perform repeated dynamic contractions at a specified submaximal load to exhaustion
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Changes from before to after the strength training intervention (week 19 to week 28)
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Bilateral upper body muscle endurance
Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)
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The ability of muscles of the upper body to perform repeated dynamic contractions at a specified submaximal load to exhaustion
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Changes from before to after the strength training intervention (week 19 to week 28)
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Unilateral lower body isokinetic muscle strength
Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)
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The ability of muscles of the lower body to exert maximal force during isokinetic movements
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Changes from before to after the strength training intervention (week 19 to week 28)
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Daily life activity level
Time Frame: Changes from before to after the intervention (week 0 to week 28)
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Daily life activity level measured using accelerometer
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Changes from before to after the intervention (week 0 to week 28)
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Muscle cell biological traits
Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)
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Muscle cell biological traits, including numbers of myonuclei, satelitte cells and capillaries, measured in biopsies from m. vastus lateralis using immunohistochemistry
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Changes from before to after the strength training intervention (week 19 to week 28)
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Muscle mitochondrial quantities
Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)
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Mitochondrial quantities measured in biopsies from m. vastus lateralis
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Changes from before to after the strength training intervention (week 19 to week 28)
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Muscle mitochondrial functions
Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)
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Mitochondrial functions measured in biopsies from m. vastus lateralis
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Changes from before to after the strength training intervention (week 19 to week 28)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Training diary
Time Frame: Measured over the course of the strength training familiarization period and the strength training intervention (week 15 to week 28)
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Training diary containing information about type of training, duration of training and training intensity
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Measured over the course of the strength training familiarization period and the strength training intervention (week 15 to week 28)
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Dietary registration
Time Frame: Registred at one time point during the strength training intervention (~week 23, registred over four days)
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Detailed registration of food intake
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Registred at one time point during the strength training intervention (~week 23, registred over four days)
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Self-reported information on lifestyle-related aspects
Time Frame: Measured over the course of the intervention (week 0 to week 28)
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Disease, symptoms, injury, vitamin D-intake, time spent outdoors, solarium, training background, smoking, etc
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Measured over the course of the intervention (week 0 to week 28)
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Knut Sindre Mølmen, MSc, Inland Norway University of Applied Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Trainsome 2014#004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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