Vitamin D and Physical Activity for Prevention of Sarcopenia in Osteoporosis
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Sarcopenia |
Drug: Vitamin D Other: Physical activity |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Effect of Vitamin D Supplementation and Physical Activity in Preventing Sarcopenia in Older Adults With Osteoporosis |
- muscle mass change [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- Muscle mass change [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
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).
| Enrollment: | 145 |
| Study Start Date: | April 2011 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vitamin D
vitamin D-oral cholecalciferol 2000 IU/day for 4 months
|
Drug: Vitamin D
vitamin D given orally as tablets at a dosage of 2000 IU/day for 4 months
Other Name: cholecalciferol
|
|
Active Comparator: Physical activity
A 3-day/week exercise programme lasting 60 minutes each day for 4 months was instigated.
|
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
|
|
Experimental: Vitamin D and Physical activity
Vitamin D -oral cholecalciferol 2000 IU/day and Physical activity-60-minute 3-day/week exercise programme
|
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
|
|
Placebo Comparator: Control
The control group was provided with health education using videotaped presentations, physician talks on topics concerning bone and muscle health.
|
Drug: Vitamin D
vitamin D given orally as tablets at a dosage of 2000 IU/day for 4 months
Other Name: cholecalciferol
|
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.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Anna Abou-Raya, Professor of Rheumatology, Faculty of Medicine, University of Alexandria |
| ClinicalTrials.gov Identifier: | NCT01666522 History of Changes |
| Other Study ID Numbers: | alexmed116671002 |
| Study First Received: | August 3, 2012 |
| Last Updated: | August 10, 2012 |
| Health Authority: | Egypt: Institutional Review Board |
Keywords provided by Faculty of Medicine, University of Alexandria:
|
sarcopenia osteopenia/osteoporosis older adults vitamin D supplementation physical activity |
Additional relevant MeSH terms:
|
Osteoporosis Sarcopenia Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Muscular Atrophy Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Atrophy Pathological Conditions, Anatomical |
Signs and Symptoms Cholecalciferol Vitamin D Ergocalciferols Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 19, 2013