The Impact of Combination of Aerobic and Resistive Exercise on Activities of Daily Living and Risk of Fall in Osteosarcopenic Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Change from Baseline on Skeletal Muscle Mass Measurement at month 1
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 70 Years to 91 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Acute infection
- •Severe edema
- •Malignancy patients
- •Severe anemia (Hgb <8 mg / dl)
Outcomes
Primary Outcomes
Change from Baseline on Skeletal Muscle Mass Measurement at month 1
Time Frame: 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
Time Frame: 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 Katz Activities of Daily Living Scale at month 3
Time Frame: Baseline and Month 3
minimum 0, maximum 6, high scores: better
Change from Baseline on Katz Activities of Daily Living Scale at month 1
Time Frame: Baseline and Month 1
minimum 0, maximum 6, high scores: better
Change from Baseline on Short Physical Performance Battery at month 1
Time Frame: Baseline and Month 1
0-low perfomance, 12-good performance
Change from Baseline on Berg Balance Test at month 1
Time Frame: 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
Time Frame: 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
Time Frame: Baseline and Month 1
Lower times: better scores
Change from Baseline on Berg Balance Test at month 3
Time Frame: 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
Time Frame: 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
Time Frame: Baseline and Month 3
0-low perfomance, 12-good performance
Change from Baseline on Five Times Sit to Stand Test at month 3
Time Frame: Baseline and Month 3
Lower times: better scores
Secondary Outcomes
No secondary outcomes reported
Investigators
Selda Çiftci
Principal investigator
Sisli Hamidiye Etfal Training and Research Hospital