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Trial record 28 of 180 for:    RET

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
Sponsor:
Collaborators:
University Hospital Birmingham
University of Surrey
Information provided by (Responsible Party):
University of Birmingham

Brief 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.

Condition or disease Intervention/treatment Phase
Sarcopenia Muscle Atrophy Osteoporosis Other: RET Dietary Supplement: Placebo Dietary Supplement: Vitamin D3 Not Applicable

Detailed 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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
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.
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: 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.




Primary Outcome Measures :
  1. Lower limb extensor power (LLEP) [ Time Frame: 6 months ]
    Nottingham Leg Extensor Power Rig


Secondary Outcome Measures :
  1. 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)

  2. Short Physical Performance Battery (SPPB) [ Time Frame: 6 months ]
    Gait speed, chair stand, balance tests

  3. Timed-up-and-go (TUG) [ Time Frame: 6 months ]
    To assess mobility

  4. Physical activity [ Time Frame: 6 months ]
    Directly monitored physical activity using accelerometry (ActivPAL)

  5. Falls as events [ Time Frame: 6 months ]
    Incidence of falls

  6. Quality of life (QoL) [ Time Frame: 6 months ]
    QoL assessed via questionnaire

  7. 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.

  8. 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)



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

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


Contacts
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Contact: Carolyn Greig, PhD C.A.Greig@bham.ac.uk
Contact: Anneka Antoniak, MRes aea423@bham.ac.uk

Locations
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United Kingdom
University of Birmingham Recruiting
Birmingham, United Kingdom, B15 2TT
Contact: Carolyn Greig, PhD         
Contact: Anneka Antoniak, MRes       aea423@bham.ac.uk   
Sponsors and Collaborators
University of Birmingham
University Hospital Birmingham
University of Surrey
Investigators
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Principal Investigator: Carolyn Greig, PhD University of Birmingham

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Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT02467153     History of Changes
Other Study ID Numbers: RG_14-185
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Keywords provided by University of Birmingham:
Sarcopenia
Older adult
Vitamin D
Physical activity
Muscle atrophy
Muscle strength
Physical function
Frailty
Osteoporosis
Additional relevant MeSH terms:
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Osteoporosis
Sarcopenia
Muscular Atrophy
Atrophy
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents