Clinical trial NCT04526327: Osteosarcopenia and Exercise
Official title: The Impact of Combination of Aerobic and Resistive Exercise on Activities of Daily Living and Risk of Fall in Osteosarcopenic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Osteoporosis, Osteopenia
Keywords: aerobic exercise
resistive exercise
balance
falling
physical performance
osteosarcopenia
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 27
Sex: ALL
Minimum age (years): 70
Maximum age (years): 91
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Female and male patients over 70 years of age followed-up from osteoporosis outpatient clinic
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Change from Baseline on Skeletal Muscle Mass Measurement at month 3
timeFrame: Baseline and Month 3
measure: Change from Baseline on Skeletal Muscle Mass Measurement at month 1
timeFrame: Baseline and Month 1
measure: Change from Baseline on Katz Activities of Daily Living Scale at month 3
timeFrame: Baseline and Month 3
measure: Change from Baseline on Katz Activities of Daily Living Scale at month 1
timeFrame: Baseline and Month 1
measure: Change from Baseline on Short Physical Performance Battery at month 3
timeFrame: Baseline and Month 3
measure: Change from Baseline on Short Physical Performance Battery at month 1
timeFrame: Baseline and Month 1
measure: Change from Baseline on Berg Balance Test at month 3
timeFrame: Baseline and Month 3
measure: Change from Baseline on Berg Balance Test at month 1
timeFrame: Baseline and Month 1
measure: Change from Baseline on Timed Up and Go Test at month 3
timeFrame: Baseline and Month 3
measure: Change from Baseline on Timed Up and Go Test at month 1
timeFrame: Baseline and Month 1
measure: Change from Baseline on Five Times Sit to Stand Test at month 3
timeFrame: Baseline and Month 3
measure: Change from Baseline on Five Times Sit to Stand Test at month 1
timeFrame: Baseline and Month 1
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Şişli Hamidiye Etfal Training and Research Hospital
Study officials:
affiliation: Şişli Hamidiye Etfal Training and Research Hospital
name: Figen Yılmaz
role: STUDY_CHAIR
References: