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

NCT02467153 | Completed

• 1 other identifier: RG_14-185
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Muscle Atrophy; Osteoporosis

Keywords

Sarcopenia; Older adult; Vitamin D; Physical activity; Muscle atrophy; Muscle strength; Physical function; Frailty; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Lower limb extensor power (LLEP)

  Nottingham Leg Extensor Power Rig

  6 months

Secondary Outcomes (9)

• Body composition and bone mineral density (BMD)

  6 months

• Short Physical Performance Battery (SPPB)

  6 months

• Timed-up-and-go (TUG)

  6 months

• Physical activity

  6 months

• Falls as events

  6 months

Study Arms (2)

RET + vitamin D3

EXPERIMENTAL

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

RET + placebo

PLACEBO COMPARATOR

Resistance Exercise Training (RET) + placebo given orally as tablets; 1 tablet per day for 6 months.

Dietary Supplement: Placebo

Interventions

RET OTHER

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.

RET + vitamin D3

Placebo DIETARY_SUPPLEMENT

Placebo given orally as tablets; 1 tablet per day for 6 months.

RET + placebo

Vitamin D3 DIETARY_SUPPLEMENT

Placebo given orally as tablets; 800 IU as 1 tablet per day for 6 months.

RET + vitamin D3

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged 65 years or over
• Ambulatory (with or without walking aids)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Birmingham: lead
• University Hospital Birmingham: collaborator
• University of Surrey: collaborator

Study Sites (1)

University of Birmingham

Birmingham, B15 2TT, United Kingdom

Location

Related Publications (1)

• Welford AE, Lanham-New S, Lord J, Doyle A, Robinson J, Nightingale P, Gittoes N, Greig CA. Influence of combined vitamin D3 supplementation and resistance exercise training on musculoskeletal health in older men and women (EXVITD): protocol for a randomised controlled trial. BMJ Open. 2020 Mar 18;10(3):e033824. doi: 10.1136/bmjopen-2019-033824.

  PMID: 32193264 DERIVED

MeSH Terms

Conditions

Sarcopenia; Muscular Atrophy; Osteoporosis; Motor Activity; Frailty

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior; Pathologic Processes

Intervention Hierarchy (Ancestors)

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

Study Officials

• Carolyn Greig, PhD

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: June 9, 2015
• Study Start: January 1, 2017
• Primary Completion: October 31, 2019
• Study Completion: December 16, 2019
• Last Updated: February 10, 2022

Record last verified: 2021-03

Locations

GB (1)