Vitamin D and Physical Activity for Prevention of Sarcopenia in Osteoporosis
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| ClinicalTrials.gov Identifier: NCT01666522 |
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Recruitment Status :
Completed
First Posted : August 16, 2012
Last Update Posted : August 16, 2012
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sarcopenia | Drug: Vitamin D Other: Physical activity | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 145 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Effect of Vitamin D Supplementation and Physical Activity in Preventing Sarcopenia in Older Adults With Osteoporosis |
| Study Start Date : | April 2011 |
| Actual Primary Completion Date : | August 2011 |
| Actual Study Completion Date : | September 2011 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Vitamin D
vitamin D-oral cholecalciferol 2000 IU/day for 4 months
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Drug: Vitamin D
vitamin D given orally as tablets at a dosage of 2000 IU/day for 4 months
Other Name: cholecalciferol |
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Active Comparator: Physical activity
A 3-day/week exercise programme lasting 60 minutes each day for 4 months was instigated.
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Other: 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.
Other Name: Exercise programme |
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Experimental: Vitamin D and Physical activity
Vitamin D -oral cholecalciferol 2000 IU/day and Physical activity-60-minute 3-day/week exercise programme
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Drug: Vitamin D
vitamin D given orally as tablets at a dosage of 2000 IU/day for 4 months
Other Name: cholecalciferol Other: 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.
Other Name: Exercise programme |
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Placebo Comparator: Control
The control group was provided with health education using videotaped presentations, physician talks on topics concerning bone and muscle health.
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Drug: Vitamin D
vitamin D given orally as tablets at a dosage of 2000 IU/day for 4 months
Other Name: cholecalciferol |
- muscle mass change [ Time Frame: 4 months ]
- Muscle mass change [ Time Frame: 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).
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| Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666522
| Egypt | |
| Faculty of Medicine | |
| Alexandria, Egypt, 00203 | |
| Responsible Party: | Anna Abou-Raya, Professor of Rheumatology, University of Alexandria |
| ClinicalTrials.gov Identifier: | NCT01666522 |
| Other Study ID Numbers: |
alexmed116671002 |
| First Posted: | August 16, 2012 Key Record Dates |
| Last Update Posted: | August 16, 2012 |
| Last Verified: | August 2012 |
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sarcopenia osteopenia/osteoporosis older adults vitamin D supplementation physical activity |
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Osteoporosis Sarcopenia Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases Muscular Atrophy Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases |
Atrophy Pathological Conditions, Anatomical Vitamin D Cholecalciferol Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |