Vitamin D and Physical Activity for Prevention of Sarcopenia in Osteoporosis

NCT01666522 | Completed DMC

• 1 other identifier: alexmed116671002
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

In the present study the aim was to determine the prevalence of sarcopenia and to evaluate the effectiveness of an exercise program and vitamin D supplementation in enhancing muscle mass and strength in community-dwelling older adults with osteopenia /osteoporosis. One hundred and forty-five individuals aged 65 years and above with documented osteopenia/osteoporosis were scanned for sarcopenia. The participants were randomly assigned to one of four groups: Group 1-PA and vitamin D (n= 38), Group 2-PA(n=36), Group 3-vitamin D (n= 36) or Group 4-healthy lifestyle(n =35) for 16 weeks. The PA group received a 60-minute 3-day/week exercise programme, the vitamin D group received oral cholecalciferol 2000 IU/day and the control group was provided with health education using videotaped presentations, physician talks on topics concerning bone and muscle health. Body composition was measured DEXA. Vitamin D levels were measured and PA was measured using the Baecke Physical Activity Questionnaire. Physical performance was assessed using upper limb grip strength, walking speed and knee extension strength. All data was collected at baseline and at 4 months.

Conditions

Sarcopenia

Keywords

sarcopenia; osteopenia/osteoporosis; older adults; vitamin D supplementation; physical activity

Outcome Measures

Primary Outcomes (2)

• muscle mass change

  4 months

• Muscle mass change

  To determine change in vitamin D status, fasting blood samples were collected from all participants at baseline and after 16 weeks of intervention and were measured by Liaison immunoassay. Muscle mass change and sarcopenia prevention was measured using the relative skeletal muscle index (appendicular skeletal muscle mass divided by height) below 5.45 kg/m2).

  4 months

Study Arms (4)

Vitamin D

EXPERIMENTAL

vitamin D-oral cholecalciferol 2000 IU/day for 4 months

Drug: Vitamin D

Physical activity

ACTIVE COMPARATOR

A 3-day/week exercise programme lasting 60 minutes each day for 4 months was instigated.

Other: Physical activity

Vitamin D and Physical activity

EXPERIMENTAL

Vitamin D -oral cholecalciferol 2000 IU/day and Physical activity-60-minute 3-day/week exercise programme

Drug: Vitamin D; Other: Physical activity

Control

PLACEBO COMPARATOR

The control group was provided with health education using videotaped presentations, physician talks on topics concerning bone and muscle health.

Drug: Vitamin D

Interventions

Vitamin D DRUG

vitamin D given orally as tablets at a dosage of 2000 IU/day for 4 months

Also known as: cholecalciferol

Control; Vitamin D; Vitamin D and Physical activity

Physical activity OTHER

Physical activity in the form of an exercise programme consisting of 60 minutes all inclusive warming up , strengthening, resistance and stretching exercises were instigated 3 times a week for 4 months.

Also known as: Exercise programme

Physical activity; Vitamin D and Physical activity

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older adults aged 60 and above
• osteopenia/osteoporosis

You may not qualify if:

• severe cognitive impairment
• major organ disease
• current consumption of corticosteroids or vitamin D

Sponsors & Collaborators

• University of Alexandria: lead

Study Sites (1)

Faculty of Medicine

Alexandria, Alexandria Governorate, 00203, Egypt

Location

MeSH Terms

Conditions

Sarcopenia; Bone Diseases, Metabolic; Motor Activity

Interventions

Vitamin D; Cholecalciferol; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rheumatology

Study Record Dates

• First Submitted: August 3, 2012
• First Posted: August 16, 2012
• Study Start: April 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: August 16, 2012

Record last verified: 2012-08

Locations

EG (1)