Vitamin D and Resistance Exercise Training; Effects on Musculoskeletal Health in Frail Older Men and Women (EXVITD)
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|ClinicalTrials.gov Identifier: NCT02467153|
Recruitment Status : Recruiting
First Posted : June 9, 2015
Last Update Posted : October 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sarcopenia Muscle Atrophy Osteoporosis||Other: RET Dietary Supplement: Placebo Dietary Supplement: Vitamin D3||Not Applicable|
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 114 men and women aged 70 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Influence of Combined Vitamin D Supplementation and Resistance Exercise Training on Musculoskeletal Health in Frail Older Men and Women (EXVITD)|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||January 2020|
Experimental: RET + vitamin D3
Resistance Exercise Training (RET) + vitamin D3 given orally as tablets at a dosage of 800 International Units (IU)/day for 6 months.
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.
Dietary Supplement: Vitamin D3
Placebo given orally as tablets; 800 IU as 1 tablet per day for 6 months.
Placebo Comparator: RET + placebo
Resistance Exercise Training (RET) + placebo given orally as tablets; 1 tablet per day for 6 months.
Dietary Supplement: Placebo
Placebo given orally as tablets; 1 tablet per day for 6 months.
- Lower limb extensor power (LLEP) [ Time Frame: 6 months ]Nottingham Leg Extensor Power Rig
- Body composition and bone mineral density (BMD) [ Time Frame: 6 months ]Body composition, hip and spine BMD measured using dual-energy X-ray absorptiometry (DXA)
- Short Physical Performance Battery (SPPB) [ Time Frame: 6 months ]Gait speed, chair stand, balance tests
- Timed-up-and-go (TUG) [ Time Frame: 6 months ]To assess mobility
- Physical activity [ Time Frame: 6 months ]Directly monitored physical activity using accelerometry (ActivPAL)
- Falls as events [ Time Frame: 6 months ]Incidence of falls
- Quality of life (QoL) [ Time Frame: 6 months ]QoL assessed via questionnaire
- Vitamin D3 and Calcium status [ Time Frame: 6 months ]Venepuncture for markers of inflammation/stress plus monitoring of serum vitamin D3 and calcium status at baseline, 1, 3 and 6 months.
- Nutrient intake [ Time Frame: 6 months ]3-day food diaries will be completed at baseline and intermittently throughout the intervention to monitor calcium intake and other nutrients (e.g. protein)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467153
|Contact: Carolyn Greig, PhD||C.A.Greig@bham.ac.uk|
|Contact: Anneka Antoniak, MResfirstname.lastname@example.org|
|University of Birmingham||Recruiting|
|Birmingham, United Kingdom, B15 2TT|
|Contact: Carolyn Greig, PhD|
|Contact: Anneka Antoniak, MRes email@example.com|
|Principal Investigator:||Carolyn Greig, PhD||University of Birmingham|