Osteosarcopenia and Exercise

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04526327
• Other study ID #: 2189
• Status: Completed
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: August 2020
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 1, 2019
• Est. primary completion date: March 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years to 91 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteoporosis
• Osteoporosis, Osteopenia
• Sarcopenia

Intervention

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

Locations

Country	Name	City	State
Turkey	Sisli Hamidiye Etfal Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change from Baseline on Katz Activities of Daily Living Scale at month 3	minimum 0, maximum 6, high scores: better	Baseline and Month 3
Primary	Change from Baseline on Katz Activities of Daily Living Scale at month 1	minimum 0, maximum 6, high scores: better	Baseline and Month 1
Primary	Change from Baseline on Short Physical Performance Battery at month 3	0-low perfomance, 12-good performance	Baseline and Month 3
Primary	Change from Baseline on Short Physical Performance Battery at month 1	0-low perfomance, 12-good performance	Baseline and Month 1
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change from Baseline on Five Times Sit to Stand Test at month 3	Lower times: better scores	Baseline and Month 3
Primary	Change from Baseline on Five Times Sit to Stand Test at month 1	Lower times: better scores	Baseline and Month 1