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Completed

NCT Number: NCT04526327

Osteosarcopenia and Exercise

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

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Key information

Conditions

Sarcopenia Atrophy Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Osteopenia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

70 year–91 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Change from Baseline on Short Physical Performance Battery at month 3

    Time frame: Baseline and Month 3

    0-low perfomance, 12-good performance

  6. Change from Baseline on Short Physical Performance Battery at month 1

    Time frame: Baseline and Month 1

    0-low perfomance, 12-good performance

  7. 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.

  8. 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.

  9. 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

  10. 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

  11. Change from Baseline on Five Times Sit to Stand Test at month 3

    Time frame: Baseline and Month 3

    Lower times: better scores

  12. Change from Baseline on Five Times Sit to Stand Test at month 1

    Time frame: Baseline and Month 1

    Lower times: better scores

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 25, 2020
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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