Vitamin D and Resistance Exercise Training; Effects on Musculoskeletal Health in Frail Older Men and Women

Osteoporosis Clinical Trial

— EXVITD  

Official title:

Influence of Combined Vitamin D Supplementation and Resistance Exercise Training on Musculoskeletal Health in Frail Older Men and Women (EXVITD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467153
• Other study ID #: RG_14-185
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 16, 2019

Study information

• Verified date: March 2021
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 16, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Aged 65 years or over

• Ambulatory (with or without walking aids)

Exclusion Criteria:

• History of myocardial infarction within previous 2 years

• Cardiac illness: moderate/ severe aortic stenosis, acute pericarditis, acute myocarditis, aneurysm, severe angina, clinically significant valvular disease, uncontrolled dysrhythmia, claudication within the previous 10 years; thrombophlebitis or pulmonary embolus within the previous 2 years

• History of cerebrovascular disease (CVA or TIA) within the previous 2 years

• Acute febrile illness within the previous 3 months

• Severe airflow obstruction; uncontrolled metabolic disease (e.g., thyroid disease or cancer)

• Significant emotional distress, psychotic illness or depression within the previous 2 years

• Lower limb fracture sustained within the previous 2 years/ upper limb fracture within the previous 6 months

• Non-arthroscopic lower limb joint surgery within the previous 2 years

• Any reason for loss of mobility for greater than 1 week in the previous 2 months or greater than 2 weeks in the previous 6 months

• Resting systolic pressure >200 millimeters of mercury (mmHg) or resting diastolic pressure >100 mmHg

• Poorly controlled atrial fibrillation; poor (chronic) pain control

• Moderate/severe cognitive impairment (mini mental state examination (MMSE) score <23)

• Vitamin D deficient (serum 25(OH)D3 <30nmol/l); current antiresorptive or anabolic treatment for osteoporosis

• Treatment with bisphosphonates for osteoporosis in the past two years

• Current supplement use of vitamin D (>400 IU/day) or calcium (>500 mg/day including use of over the counter preparations)

• Current use of glucocorticoids; known primary hyperparathyroidism; hypercalcaemia (albumin-adjusted serum calcium >2.60 mmol/l)

• Renal impairment (Stage 4 or 5)

Related Conditions & MeSH terms

• Atrophy
• Muscle Atrophy
• Muscular Atrophy
• Osteoporosis
• Sarcopenia

Intervention

Other:
• RET
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:
• Placebo
Placebo given orally as tablets; 1 tablet per day for 6 months.
• Vitamin D3
Placebo given orally as tablets; 800 IU as 1 tablet per day for 6 months.

Locations

Country	Name	City	State
United Kingdom	University of Birmingham	Birmingham

Sponsors (3)

Lead Sponsor	Collaborator
University of Birmingham	University Hospital Birmingham, University of Surrey

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower limb extensor power (LLEP)	Nottingham Leg Extensor Power Rig	6 months
Secondary	Body composition and bone mineral density (BMD)	Body composition, hip and spine BMD measured using dual-energy X-ray absorptiometry (DXA)	6 months
Secondary	Short Physical Performance Battery (SPPB)	Gait speed, chair stand, balance tests	6 months
Secondary	Timed-up-and-go (TUG)	To assess mobility	6 months
Secondary	Physical activity	Directly monitored physical activity using accelerometry (ActivPAL)	6 months
Secondary	Falls as events	Incidence of falls	6 months
Secondary	Quality of life (QoL)	QoL assessed via questionnaire	6 months
Secondary	Serum blood monitoring	Venepuncture for markers of inflammation plus monitoring of serum vitamin D3 and calcium status at baseline, 1, 3 and 6 months.	6 months
Secondary	Muscle power	Chair rise test using Leonardo Mechanograph Ground Reaction Force Plate	6 months
Secondary	3-day Dietary analysis	3-day food diary record	6 months