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Clinical Trials/NCT04526327
NCT04526327
Completed
N/A

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

Sisli Hamidiye Etfal Training and Research Hospital1 site in 1 country27 target enrollmentDecember 3, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sarcopenia
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
Enrollment
27
Locations
1
Primary Endpoint
Change from Baseline on Skeletal Muscle Mass Measurement at month 1
Status
Completed
Last Updated
5 years ago

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

Registry
clinicaltrials.gov
Start Date
December 3, 2018
End Date
October 1, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Selda Çiftci

Principal investigator

Sisli Hamidiye Etfal Training and Research Hospital

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
  • Acute infection
  • Severe edema
  • Malignancy patients

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

Study Sites (1)

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