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Osteosarcopenia and Exercise

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04526327
Enrollment
27
Registered
2020-08-25
Start date
2018-12-03
Completion date
2019-10-01
Last updated
2020-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Osteopenia, Sarcopenia

Keywords

aerobic exercise, resistive exercise, balance, falling, physical performance, osteosarcopenia

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

Interventions

OTHERexercise

the combination of aerobic and resistive exercise, three time a week

Sponsors

Sisli Hamidiye Etfal Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Female and male patients over 70 years of age followed-up from osteoporosis outpatient clinic

Eligibility

Sex/Gender
ALL
Age
70 Years to 91 Years
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 * Dialysis * Acute infection * Severe edema * Malignancy patients * Severe anemia (Hgb \<8 mg / dl)

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline on Skeletal Muscle Mass Measurement at month 3Baseline and Month 3Assessment with bioelectrical body composition analyzer male: SMI\<9,2 kg/m2 female: SMI\<7,4 kg/m2
Change from Baseline on Skeletal Muscle Mass Measurement at month 1Baseline and Month 1Assessment with bioelectrical body composition analyzer male: SMI\<9,2 kg/m2 female: SMI\<7,4 kg/m2
Change from Baseline on Katz Activities of Daily Living Scale at month 3Baseline and Month 3minimum 0, maximum 6, high scores: better
Change from Baseline on Katz Activities of Daily Living Scale at month 1Baseline and Month 1minimum 0, maximum 6, high scores: better
Change from Baseline on Short Physical Performance Battery at month 3Baseline and Month 30-low perfomance, 12-good performance
Change from Baseline on Short Physical Performance Battery at month 1Baseline and Month 10-low perfomance, 12-good performance
Change from Baseline on Berg Balance Test at month 3Baseline and Month 3maximum 56 point, a score of \< 45 indicates individuals may be at greater risk of falling.
Change from Baseline on Berg Balance Test at month 1Baseline and Month 1maximum 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 3Baseline and Month 3Stand 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 Timed Up and Go Test at month 1Baseline and Month 1Stand 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 3Baseline and Month 3Lower times: better scores
Change from Baseline on Five Times Sit to Stand Test at month 1Baseline and Month 1Lower times: better scores

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026