- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01666522
Vitamin D and Physical Activity for Prevention of Sarcopenia in Osteoporosis
Effect of Vitamin D Supplementation and Physical Activity in Preventing Sarcopenia in Older Adults With Osteoporosis
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Alexandria, Egypten, 00203
- Faculty of Medicine
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Vitamin D
vitamin D-oral cholecalciferol 2000 IU/day for 4 months
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vitamin D given orally as tablets at a dosage of 2000 IU/day for 4 months
Andra namn:
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Aktiv komparator: Physical activity
A 3-day/week exercise programme lasting 60 minutes each day for 4 months was instigated.
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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.
Andra namn:
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Experimentell: 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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vitamin D given orally as tablets at a dosage of 2000 IU/day for 4 months
Andra namn:
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.
Andra namn:
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Placebo-jämförare: 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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vitamin D given orally as tablets at a dosage of 2000 IU/day for 4 months
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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muscle mass change
Tidsram: 4 months
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4 months
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Muscle mass change
Tidsram: 4 months
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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). |
4 months
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Metaboliska sjukdomar
- Sjukdomar i nervsystemet
- Neurologiska manifestationer
- Muskuloskeletala sjukdomar
- Neuromuskulära manifestationer
- Patologiska tillstånd, anatomiska
- Skelettsjukdomar
- Muskelatrofi
- Atrofi
- Skelettsjukdomar, metaboliska
- Sarkopeni
- Osteoporos
- Läkemedels fysiologiska effekter
- Mikronäringsämnen
- Vitaminer
- Bendensitetsbevarande medel
- Kalciumreglerande hormoner och medel
- Vitamin D
- Kolekalciferol
Andra studie-ID-nummer
- alexmed116671002
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