Vitamin D and Physical Activity for Prevention of Sarcopenia in Osteoporosis

Not Applicable

Completed

• Conditions: Sarcopenia
• Interventions: Drug: Vitamin D; Other: Physical activity

• Registration Number: NCT01666522
• Lead Sponsor: University of Alexandria

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.

Detailed Description

Ageing is associated with changes in body composition and due to the ageing of the populations and the lessened physical activity (PA), sarcopenia and osteopenia /osteoporosis are emerging as major health concerns. Lack of PA is a significant risk factor for sarcopenia. Vitamin D plays an important role on bone and muscle development.

This study was conducted to determine the prevalence of sarcopenia and to evaluate the effectiveness of PA 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 (defined as a relative skeletal muscle index (appendicular skeletal muscle mass divided by height) below 5.45 kg/m2). 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 by dual energy X-ray absorptiometry (DEXA). Vitamin D levels were measured by Liaison immunoassay. 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.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-08
• Study Completion: 2011-09
• Status Verified: 2012-08
• Study First Submitted: 2012-08-03
• Study First Submitted QC: 2012-08-10
• Last Update Submitted: 2012-08-10
• Study First Posted: 2012-08-16
• Last Update Posted: 2012-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

• older adults aged 60 and above
• osteopenia/osteoporosis

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D and Physical activity	Vitamin D	Vitamin D -oral cholecalciferol 2000 IU/day and Physical activity-60-minute 3-day/week exercise programme
Vitamin D and Physical activity	Physical activity	Vitamin D -oral cholecalciferol 2000 IU/day and Physical activity-60-minute 3-day/week exercise programme
Vitamin D	Vitamin D	vitamin D-oral cholecalciferol 2000 IU/day for 4 months
Physical activity	Physical activity	A 3-day/week exercise programme lasting 60 minutes each day for 4 months was instigated.
Control	Vitamin D	The control group was provided with health education using videotaped presentations, physician talks on topics concerning bone and muscle health.

Primary Outcome Measures

Name	Time	Method
muscle mass change	4 months
Muscle mass change	4 months	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).

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Alexandria, Egypt