The Granheim COPD Study - Vitamin D and Strength Training

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02598830
• Date of registration: 05/11/2015
• Prospective Registration: No
• Primary sponsor: Inland Norway University of Applied Sciences
• Public title: The Granheim COPD Study - Vitamin D and Strength Training
• Scientific 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
• Date of first enrolment: November 2015
• Target sample size: 97
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02598830
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Norway

Contacts

• Name: Knut Sindre Mølmen, MSc
• Affiliation: Inland Norway University of Applied Sciences

Key inclusion & exclusion criteria

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



Age minimum: 45 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease

Intervention(s)

Dietary Supplement: Placebo

Dietary Supplement: Vitamin D3

Primary Outcome(s)

Muscle phenotype [Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)]

Muscle size [Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)]

Secondary Outcome(s)

Bilateral upper body muscle endurance [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)]

Muscle mitochondrial functions [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)]

Step test [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)]

Bilateral upper body maximal strength [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)]

Cytokines in blood [Time Frame: Changes over the course of the intervention (week 0 to 28)]

Gene expression in skeletal muscle [Time Frame: Changes from before to after familiarization to strength training (week 15 to week 17)]

Gene expression in skeletal muscle [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)]

Unilateral lower body muscle endurance [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)]

Pasient-reported outcome measures, generic [Time Frame: Changes from before to after the strength training intervention (week 19 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)]

Daily life activity level [Time Frame: Changes from before to after the intervention (week 0 to week 28)]

Protein abundances in skeletal muscle [Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)]

Vitamin D in blood [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)]

Body mass composition [Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)]

Lung function [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)]

Steroids in skeletal muscle [Time Frame: Changes over the course of the intervention (week 0 to 28)]

Unilateral lower body maximal muscle strength [Time Frame: Changes from before to after the strength training intervention (week 19 to week 28)]

Secondary ID(s)

Trainsome 2014#004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sykehuset Innlandet HF

University of Bergen

University of Copenhagen

Lillehammer Hospital for Rheumatic Diseases

Norwegian School of Sport Sciences