Osteosarcopenia and Exercise
- Conditions
- Osteoporosis, OsteopeniaSarcopenia
- Interventions
- Other: exercise
- Registration Number
- NCT04526327
- Lead Sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Brief Summary
The purpose of this study is to assess the efficacy of combination of aerobic and resistive exercise on activities of daily living and risk of fall in osteosarcopenic patients
- Detailed Description
After being informed about the study and potential risk, all patients giving written informed consent will undergo study entry.
to begin with: assessment with bioelectrical body composition analyzer and first exercise and assessment clinical scales
1th month: assessment with bioelectrical body composition analyzer and assessment clinical scales 3th month: assessment with bioelectrical body composition analyzer and assessment clinical scales
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
- Over 70 years of age
- Clinical diagnosis of osteoporosis or osteopenia
- Independent mobilization
- Walking speed < 0.8 m / sec
- Grip strength < 20 kg for women, < 30 kg for men
- Uncontrolled hypertension (systolic blood pressure> 200 mmHg, diastolic blood pressure> 110 mmHg)
- Uncontrolled diabetes mellitus
- Stroke, hip fracture, knee and hip arthroplasty, spinal surgery in the last 6 months
- Severe cardiac arrhythmia
- Myocardial infarction in the last 6 months
- Severe dementia and difficulties in cooperation
- Cardiac pacemaker
- Dialysis
- Acute infection
- Severe edema
- Malignancy patients
- Severe anemia (Hgb <8 mg / dl)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description exercise group exercise Female and male patients over 70 years of age with osteoporosis and sarcopenia
- Primary Outcome Measures
Name Time Method Change from Baseline on Skeletal Muscle Mass Measurement at month 1 Baseline and Month 1 Assessment with bioelectrical body composition analyzer male: SMI\<9,2 kg/m2 female: SMI\<7,4 kg/m2
Change from Baseline on Timed Up and Go Test at month 3 Baseline and Month 3 Stand up and walk 3 meters, turn around, walks back to the chair and sit down.14 seconds or longer : high risk for falling
Change from Baseline on Short Physical Performance Battery at month 1 Baseline and Month 1 0-low perfomance, 12-good performance
Change from Baseline on Katz Activities of Daily Living Scale at month 1 Baseline and Month 1 minimum 0, maximum 6, high scores: better
Change from Baseline on Katz Activities of Daily Living Scale at month 3 Baseline and Month 3 minimum 0, maximum 6, high scores: better
Change from Baseline on Berg Balance Test at month 1 Baseline and Month 1 maximum 56 point, a score of \< 45 indicates individuals may be at greater risk of falling.
Change from Baseline on Timed Up and Go Test at month 1 Baseline and Month 1 Stand up and walk 3 meters, turn around, walks back to the chair and sit down.14 seconds or longer : high risk for falling
Change from Baseline on Five Times Sit to Stand Test at month 1 Baseline and Month 1 Lower times: better scores
Change from Baseline on Berg Balance Test at month 3 Baseline and Month 3 maximum 56 point, a score of \< 45 indicates individuals may be at greater risk of falling.
Change from Baseline on Skeletal Muscle Mass Measurement at month 3 Baseline and Month 3 Assessment with bioelectrical body composition analyzer male: SMI\<9,2 kg/m2 female: SMI\<7,4 kg/m2
Change from Baseline on Short Physical Performance Battery at month 3 Baseline and Month 3 0-low perfomance, 12-good performance
Change from Baseline on Five Times Sit to Stand Test at month 3 Baseline and Month 3 Lower times: better scores
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Şişli Hamidiye Etfal Training and Research Hospital
🇹🇷Istanbul, Turkey