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Vitamin D and Physical Activity for Prevention of Sarcopenia in Osteoporosis

NCT ID: NCT01666522

Last Updated: 2012-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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Sarcopenia

Keywords

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sarcopenia osteopenia/osteoporosis older adults vitamin D supplementation physical activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D

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

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

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

Physical activity

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

Group Type ACTIVE_COMPARATOR

Physical activity

Intervention Type 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.

Vitamin D and Physical activity

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

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

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

Physical activity

Intervention Type 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.

Control

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

Group Type PLACEBO_COMPARATOR

Vitamin D

Intervention Type DRUG

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

Interventions

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Vitamin D

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

Intervention Type DRUG

Physical activity

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.

Intervention Type OTHER

Other Intervention Names

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cholecalciferol Exercise programme

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alexandria

OTHER

Sponsor Role lead

Responsible Party

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Anna Abou-Raya

Professor of Rheumatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine

Alexandria, Alexandria Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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alexmed116671002

Identifier Type: -

Identifier Source: org_study_id