Osteosarcopenia and Exercise

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

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

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Osteoporosis, Osteopenia
• Intervention / Treatment: Other: exercise

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Sisli Hamidiye Etfal Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 91 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: exercise group; Female and male patients over 70 years of age with osteoporosis and sarcopenia	Other: exercise; the combination of aerobic and resistive exercise, three time a week

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Investigators: Study Chair: Figen Yılmaz, Sisli Hamidiye Etfal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): March 3, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 25, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: aerobic exercise; physical performance; balance; falling; resistive exercise; osteosarcopenia
• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Bone Diseases; Muscular Atrophy; Atrophy; Sarcopenia; Osteoporosis; Bone Diseases, Metabolic
• Other Study ID Numbers: 2189

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No