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Vitamin D and Physical Activity for Prevention of Sarcopenia in Osteoporosis

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin D
Physical activity
Sponsored by
University of Alexandria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring sarcopenia, osteopenia/osteoporosis, older adults, vitamin D supplementation, physical activity

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Placebo Comparator

Arm Label

Vitamin D

Physical activity

Vitamin D and Physical activity

Control

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

muscle mass change
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).

Secondary Outcome Measures

Full Information

First Posted
August 3, 2012
Last Updated
August 10, 2012
Sponsor
University of Alexandria
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1. Study Identification

Unique Protocol Identification Number
NCT01666522
Brief Title
Vitamin D and Physical Activity for Prevention of Sarcopenia in Osteoporosis
Official Title
Effect of Vitamin D Supplementation and Physical Activity in Preventing Sarcopenia in Older Adults With Osteoporosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alexandria

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
sarcopenia, osteopenia/osteoporosis, older adults, vitamin D supplementation, physical activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
vitamin D-oral cholecalciferol 2000 IU/day for 4 months
Arm Title
Physical activity
Arm Type
Active Comparator
Arm Description
A 3-day/week exercise programme lasting 60 minutes each day for 4 months was instigated.
Arm Title
Vitamin D and Physical activity
Arm Type
Experimental
Arm Description
Vitamin D -oral cholecalciferol 2000 IU/day and Physical activity-60-minute 3-day/week exercise programme
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
The control group was provided with health education using videotaped presentations, physician talks on topics concerning bone and muscle health.
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
cholecalciferol
Intervention Description
vitamin D given orally as tablets at a dosage of 2000 IU/day for 4 months
Intervention Type
Other
Intervention Name(s)
Physical activity
Other Intervention Name(s)
Exercise programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
muscle mass change
Time Frame
4 months
Title
Muscle mass change
Description
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).
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Medicine
City
Alexandria
ZIP/Postal Code
00203
Country
Egypt

12. IPD Sharing Statement

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Vitamin D and Physical Activity for Prevention of Sarcopenia in Osteoporosis

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