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Vitamin D and Physical Activity for Prevention of Sarcopenia in Osteoporosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01666522
First Posted: August 16, 2012
Last Update Posted: August 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anna Abou-Raya, Faculty of Medicine, University of Alexandria
  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
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

Resource links provided by NLM:


Further study details as provided by Anna Abou-Raya, Faculty of Medicine, University of Alexandria:

Primary Outcome Measures:
  • 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).



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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Egypt
Faculty of Medicine
Alexandria, Egypt, 00203
Sponsors and Collaborators
Faculty of Medicine, University of Alexandria
  More Information

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
First Submitted: August 3, 2012
First Posted: August 16, 2012
Last Update Posted: August 16, 2012
Last Verified: August 2012

Keywords provided by Anna Abou-Raya, 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
Metabolic Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents