Osteosarcopenia and Exercise

Study Overview
=================
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

Official Title
-----------------
The Impact of Combination of Aerobic and Resistive Exercise on Activities of Daily Living and Risk of Fall in Osteosarcopenic Patients

Conditions
-----------------
Sarcopenia, Osteoporosis, Osteopenia

Intervention / Treatment
-----------------
* Other: exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
-----------------
Minimum Age: 70 Years
Maximum Age: 91 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Female and male patients over 70 years of age followed-up from osteoporosis outpatient clinic
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: exercise group<br>Female and male patients over 70 years of age with osteoporosis and sarcopenia | Other: exercise<br>* the combination of aerobic and resistive exercise, three time a week<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline on Skeletal Muscle Mass Measurement at month 3 | Assessment with bioelectrical body composition analyzer male: SMI<9,2 kg/m2 female: SMI<7,4 kg/m2 | Baseline and Month 3 | 
| Change from Baseline on Skeletal Muscle Mass Measurement at month 1 | Assessment with bioelectrical body composition analyzer male: SMI<9,2 kg/m2 female: SMI<7,4 kg/m2 | Baseline and Month 1 | 
| Change from Baseline on Katz Activities of Daily Living Scale at month 3 | minimum 0, maximum 6, high scores: better | Baseline and Month 3 | 
| Change from Baseline on Katz Activities of Daily Living Scale at month 1 | minimum 0, maximum 6, high scores: better | Baseline and Month 1 | 
| Change from Baseline on Short Physical Performance Battery at month 3 | 0-low perfomance, 12-good performance | Baseline and Month 3 | 
| Change from Baseline on Short Physical Performance Battery at month 1 | 0-low perfomance, 12-good performance | Baseline and Month 1 | 
| Change from Baseline on Berg Balance Test at month 3 | maximum 56 point, a score of < 45 indicates individuals may be at greater risk of falling. | Baseline and Month 3 | 
| Change from Baseline on Berg Balance Test at month 1 | maximum 56 point, a score of < 45 indicates individuals may be at greater risk of falling. | Baseline and Month 1 | 
| Change from Baseline on Timed Up and Go Test at 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 | Baseline and Month 3 | 
| Change from Baseline on Timed Up and Go Test at 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 | Baseline and Month 1 | 
| Change from Baseline on Five Times Sit to Stand Test at month 3 | Lower times: better scores | Baseline and Month 3 | 
| Change from Baseline on Five Times Sit to Stand Test at month 1 | Lower times: better scores | Baseline and Month 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aerobic exercise, resistive exercise, balance, falling, physical performance, osteosarcopenia