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Osteosarcopenia and Exercise

Primary Purpose

Sarcopenia, Osteoporosis, Osteopenia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercise
Sponsored by
Sisli Hamidiye Etfal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring aerobic exercise, resistive exercise, balance, falling, physical performance, osteosarcopenia

Eligibility Criteria

70 Years - 91 Years (Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Şişli Hamidiye Etfal Training and Research Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

exercise group

Arm Description

Female and male patients over 70 years of age with osteoporosis and sarcopenia

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 19, 2020
Last Updated
August 24, 2020
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04526327
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
March 3, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sisli Hamidiye Etfal Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Osteoporosis, Osteopenia
Keywords
aerobic exercise, resistive exercise, balance, falling, physical performance, osteosarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Female and male patients over 70 years of age followed-up from osteoporosis outpatient clinic
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
exercise group
Arm Type
Other
Arm Description
Female and male patients over 70 years of age with osteoporosis and sarcopenia
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
the combination of aerobic and resistive exercise, three time a week
Primary Outcome Measure Information:
Title
Change from Baseline on Skeletal Muscle Mass Measurement at month 3
Description
Assessment with bioelectrical body composition analyzer male: SMI<9,2 kg/m2 female: SMI<7,4 kg/m2
Time Frame
Baseline and Month 3
Title
Change from Baseline on Skeletal Muscle Mass Measurement at month 1
Description
Assessment with bioelectrical body composition analyzer male: SMI<9,2 kg/m2 female: SMI<7,4 kg/m2
Time Frame
Baseline and Month 1
Title
Change from Baseline on Katz Activities of Daily Living Scale at month 3
Description
minimum 0, maximum 6, high scores: better
Time Frame
Baseline and Month 3
Title
Change from Baseline on Katz Activities of Daily Living Scale at month 1
Description
minimum 0, maximum 6, high scores: better
Time Frame
Baseline and Month 1
Title
Change from Baseline on Short Physical Performance Battery at month 3
Description
0-low perfomance, 12-good performance
Time Frame
Baseline and Month 3
Title
Change from Baseline on Short Physical Performance Battery at month 1
Description
0-low perfomance, 12-good performance
Time Frame
Baseline and Month 1
Title
Change from Baseline on Berg Balance Test at month 3
Description
maximum 56 point, a score of < 45 indicates individuals may be at greater risk of falling.
Time Frame
Baseline and Month 3
Title
Change from Baseline on Berg Balance Test at month 1
Description
maximum 56 point, a score of < 45 indicates individuals may be at greater risk of falling.
Time Frame
Baseline and Month 1
Title
Change from Baseline on Timed Up and Go Test at month 3
Description
Stand up and walk 3 meters, turn around, walks back to the chair and sit down.14 seconds or longer : high risk for falling
Time Frame
Baseline and Month 3
Title
Change from Baseline on Timed Up and Go Test at month 1
Description
Stand up and walk 3 meters, turn around, walks back to the chair and sit down.14 seconds or longer : high risk for falling
Time Frame
Baseline and Month 1
Title
Change from Baseline on Five Times Sit to Stand Test at month 3
Description
Lower times: better scores
Time Frame
Baseline and Month 3
Title
Change from Baseline on Five Times Sit to Stand Test at month 1
Description
Lower times: better scores
Time Frame
Baseline and Month 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
91 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Figen Yılmaz
Organizational Affiliation
Şişli Hamidiye Etfal Training and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Şişli Hamidiye Etfal Training and Research Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Osteosarcopenia and Exercise

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