Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04526327
Other study ID # 2189
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06287502 - Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis N/A
Recruiting NCT05063279 - RELIEF - Resistance Training for Life N/A
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Recruiting NCT06143592 - Inspiratory Muscle Training on Balance, Falls and Diaphragm Thickness in the Elderly N/A
Terminated NCT04350762 - Nutritional Supplementation in the Elderly With Weight Loss N/A
Enrolling by invitation NCT05953116 - Managing the Nutritional Needs of Older Filipino With Due Attention to Protein Nutrition and Functional Health Study N/A
Recruiting NCT04028206 - Resistance Exercise or Vibration With HMB for Sarcopenia N/A
Enrolling by invitation NCT03297632 - Improving Muscle Strength, Mass and Physical Function in Older Adults N/A
Completed NCT04015479 - Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults N/A
Completed NCT03234920 - Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation After Liver Transplantation N/A
Recruiting NCT03998202 - Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Recruiting NCT04717869 - Identifying Modifiable PAtient Centered Therapeutics (IMPACT) Frailty
Completed NCT05497687 - Strength-building Lifestyle-integrated Intervention N/A
Completed NCT03119610 - The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity Phase 1/Phase 2
Recruiting NCT05711095 - The Anabolic Properties of Fortified Plant-based Protein in Older People N/A
Recruiting NCT05008770 - Trial in Elderly With Musculoskeletal Problems Due to Underlying Sarcopenia - Faeces to Unravel Gut and Inflammation Translationally
Not yet recruiting NCT05860556 - Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Recruiting NCT04545268 - Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance N/A
Recruiting NCT04522609 - Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant N/A
Recruiting NCT03160326 - The QUALITY Vets Project: Muscle Quality and Kidney Disease