The Granheim COPD Study - Vitamin D and Strength Training

NCT02598830 | Completed DMC

• 1 other identifier: Trainsome 2014#004
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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. In each stratum, half the participants will receive vitamin D supplementation and half the participants will receive placebo

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Cachexia; Vitamin D; Muscle; Strength training

Outcome Measures

Primary Outcomes (2)

• Muscle size

  Muscle cell cross-sectional area measured in biopsies from m. vastus lateralis using immunohistochemistry

  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

  Changes from before to after the strength training intervention (week 19 to week 28)

Secondary Outcomes (26)

• Lung function

  Changes from before to after the strength training intervention (week 19 to week 28)

• One-legged cycling

  Changes from before to after the strength training intervention (week 19 to week 28)

• Hormones in blood

  Changes over the course of the intervention (week 0 to 28)

• Cytokines in blood

  Changes over the course of the intervention (week 0 to 28)

• Steroids in skeletal muscle

  Changes over the course of the intervention (week 0 to 28)

Other Outcomes (3)

• Training diary

  Measured over the course of the strength training familiarization period and the strength training intervention (week 15 to week 28)

• Dietary registration

  Registred at one time point during the strength training intervention (~week 23, registred over four days)

• Self-reported information on lifestyle-related aspects

  Measured over the course of the intervention (week 0 to week 28)

Study Arms (2)

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

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

Dietary Supplement: Placebo

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Vitamin D3 dissolved in olive oil, encapsuled

Also known as: cholecalciferol

Vitamin D3+str.training, COPD & Healthy

Placebo DIETARY_SUPPLEMENT

Olive oil, encapsuled

Placebo+str.training, COPD & Healthy

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable COPD at GOLD stage II or III, FEV1/FVC \< 0.7 and FEV1 \<80% and \>30% of predicted
• \>45 years of age

You may not qualify if:

• 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
• \- \>45 years of age
• COPD
• Unstable cardiovascular disease
• Chronic granulomatous

Sponsors & Collaborators

• Inland Norway University of Applied Sciences: lead
• Sykehuset Innlandet HF: collaborator
• Lillehammer Hospital for Rheumatic Diseases: collaborator
• University of Bergen: collaborator
• University of Copenhagen: collaborator
• Norwegian School of Sport Sciences: collaborator

Study Sites (1)

Inland Norway University of Applied Sciences

Lillehammer, Norway

Location

Related Publications (1)

• 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.

  PMID: 34229714 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Cachexia

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Thinness

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Knut Sindre Mølmen, MSc

  Inland Norway University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 6, 2015
• Study Start: November 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share

Locations

NO (1)