An interventional study of RET and Placebo in Sarcopenia, Muscle Atrophy and Osteoporosis, sponsored by University of Birmingham. Completed at 1 site in United Kingdom. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-10.
Sponsored by University of Birmingham · Not applicable, Interventional, and Supportive care
This study aims to determine whether vitamin D3 supplementation is any more effective in improving musculoskeletal function when combined with exercise training compared with exercise training alone.
We are an ageing population with life expectancy currently increasing at 2 years per decade. Crucially, healthy life expectancy is not keeping pace and older adults are now spending longer in poor health.
Sarcopenia represents a major, serious and increasing public health problem. While the causes of sarcopenia are still unclear, vitamin D deficiency, which is widespread among older adults (reaching 90% in residential care), is associated with an increased risk of falls and fractures as well as skeletal muscle weakness. While it is known that vitamin D is essential for bone health, relatively little is known about the direct effects of vitamin D3 supplementation on human muscle mass and function in humans.
Physical activity (resistance exercise training (RET) in particular) is the most potent stimulus for skeletal muscle hypertrophy in both young and older adults. The researchers and others have shown that even in very old adults (>75 years) and frail patient groups, RET improves muscle strength and functional outcomes although the hypertrophic ability of older muscle is blunted compared with younger adults. Therefore in order to help older adults maintain good musculoskeletal health, interventions to optimise responsiveness to physical activity are likely to be most effective if they are multimodal, and include resistance exercise. One example of this is to combine resistance exercise training with vitamin D supplementation.
The aim of the EXVITD study is to determine whether vitamin D3 supplementation is any more effective in improving musculoskeletal function when combined with exercise training compared with exercise training alone.
The researchers aim to recruit 127 men and women aged 65 years or over who are ambulatory (with or without walking aids) and live in supported housing settings. Recruitment will be via local housing trusts/seniors groups.
Participants will be randomised to RET (x3 per week) + 800 International Units (IU) vitamin D3 (daily) supplement or RET + placebo for six months. Participants will be stratified on the basis of vitamin D status, physical activity (measured directly pre-randomisation using accelerometry), and sex.
Tests will include, but are not limited to, lower limb extensor power (LLEP) output, body composition, Short Physical Performance Battery (SPPB), Timed-up-and-go (TUG),power required to rise from a chair, physical activity, perception of musculoskeletal comfort/pain, falls as events, quality of life and venepuncture for biochemical markers.
1,240 studies on the registry are indexed under Sarcopenia; 405 are open to participants now.
This study's enrollment of 19 is below the median of 60 across 793 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →University of Birmingham is the lead sponsor of 182 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Resistance Exercise Training (RET) + vitamin D3 given orally as tablets at a dosage of 800 International Units (IU)/day for 6 months.
Other: RET · Dietary Supplement: Vitamin D3
Resistance Exercise Training (RET) + placebo given orally as tablets; 1 tablet per day for 6 months.
Dietary Supplement: Placebo
RET: A supervised group exercise programme with a maximum of n=10-12 participants per group to be attended 3 times per week for 6 months. The RET programme includes elements of current established programmes for falls prevention/ core stability (i.e., OTAGO, PEPPI) and will tailored to a range of abilities within the target group. Vitamin D3 supplementation: vitamin D3 given orally as tablets at a dosage of 800 IU/day for 6 months.
Placebo given orally as tablets; 1 tablet per day for 6 months.
Placebo given orally as tablets; 800 IU as 1 tablet per day for 6 months.
Lower limb extensor power (LLEP)
Nottingham Leg Extensor Power Rig
Time frame: 6 months
Body composition and bone mineral density (BMD)
Body composition, hip and spine BMD measured using dual-energy X-ray absorptiometry (DXA)
Time frame: 6 months
Short Physical Performance Battery (SPPB)
Gait speed, chair stand, balance tests
Time frame: 6 months
Timed-up-and-go (TUG)
To assess mobility
Time frame: 6 months
Physical activity
Directly monitored physical activity using accelerometry (ActivPAL)
Time frame: 6 months
Falls as events
Incidence of falls
Time frame: 6 months
Quality of life (QoL)
QoL assessed via questionnaire
Time frame: 6 months
Serum blood monitoring
Venepuncture for markers of inflammation plus monitoring of serum vitamin D3 and calcium status at baseline, 1, 3 and 6 months.
Time frame: 6 months
Muscle power
Chair rise test using Leonardo Mechanograph Ground Reaction Force Plate
Time frame: 6 months
3-day Dietary analysis
3-day food diary record
Time frame: 6 months
Ran from Jan 2017 to primary completion in Oct 2019, 33 months.
Of 474 non-industry interventional studies with no phase under Sarcopenia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's 33 months is above that.
Counting every sponsor, half of 485 studies reached it within 18 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cholecalciferol