SarcopeniaNCT04526327
Osteosarcopenia and Exercise
A study testing exercise in people with Sarcopenia and Osteoporosis, Osteopenia, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 Read more about this study
- Who is it for?
- Ages 70 to 91 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Osteoporosis, Osteopenia
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Dec 2018to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 91 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- Cardiac pacemaker
- Dialysis
- Acute infection
- Severe edema
- Malignancy patients
- Severe anemia (Hgb <8 mg / dl)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Şişli Hamidiye Etfal Training and Research Hospital
Istanbul
About this study
Official title: 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
Read the 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
- Conditions
- Sarcopenia, Osteoporosis, Osteopenia
- Being tested
- exercise
- Keywords
- aerobic exercise, resistive exercise, balance, falling, physical performance, osteosarcopenia
- Medical subject headings
- Sarcopenia, Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
the combination of aerobic and resistive exercise, three time a week
| Study group | Role | What they receive |
|---|---|---|
| exercise group | Other | Female and male patients over 70 years of age with osteoporosis and sarcopenia Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline and Month 1
Change from Baseline on Katz Activities of Daily Living Scale at month 3
minimum 0, maximum 6, high scores: better
Measured: Baseline and Month 3
Change from Baseline on Katz Activities of Daily Living Scale at month 1
minimum 0, maximum 6, high scores: better
Measured: Baseline and Month 1
Change from Baseline on Short Physical Performance Battery at month 3
0-low perfomance, 12-good performance
Measured: Baseline and Month 3
Change from Baseline on Short Physical Performance Battery at month 1
0-low perfomance, 12-good performance
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline and Month 1
Change from Baseline on Five Times Sit to Stand Test at month 3
Lower times: better scores
Measured: Baseline and Month 3
Change from Baseline on Five Times Sit to Stand Test at month 1
Lower times: better scores
Measured: Baseline and Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start3 Dec 2018
- Primary completion3 Mar 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Female and male patients over 70 years of age followed-up from osteoporosis outpatient clinic
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selda Çiftci, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Figen Yılmaz, Study chair, Şişli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526327
- Sponsor's protocol ID
- 2189
- Status last verified
- Aug 2020
- First submitted
- 19 Aug 2020
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Combination of Aerobic and Resistive Exercise on Activities of Daily Living and Risk of Fall in Osteosarcopenic Patients
- ClinicalTrials.gov ID
- NCT04526327
- Acronym / sponsor ID
- 2189
- Conditions
- Sarcopenia, Osteoporosis, Osteopenia
- Keywords
- aerobic exercise, resistive exercise, balance, falling, physical performance, osteosarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 3 Mar 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 25 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Female and male patients over 70 years of age followed-up from osteoporosis outpatient clinic
| Arm | Type | Receives |
|---|---|---|
| exercise group | Other | Other: exerciseFemale and male patients over 70 years of age with osteoporosis and sarcopenia |
Who may qualify
- Ages
- 70 to 91 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercisethe combination of aerobic and resistive exercise, three time a week | Other | exercise group |
Primary outcome
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
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
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
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
Change from Baseline on Short Physical Performance Battery at month 3
Time frame: Baseline and Month 3
0-low perfomance, 12-good performance
Change from Baseline on Short Physical Performance Battery at month 1
Time frame: Baseline and Month 1
0-low perfomance, 12-good performance
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.
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.
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
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
Change from Baseline on Five Times Sit to Stand Test at month 3
Time frame: Baseline and Month 3
Lower times: better scores
Change from Baseline on Five Times Sit to Stand Test at month 1
Time frame: Baseline and Month 1
Lower times: better scores
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Sarcopenia
Active, not recruitingObservational study
Possible Sarcopenia, Sarcopenia, and Functional Status in Patients With Primary Sjögren's Syndrome
Primary Sjögren Syndrome, Sarcopenia
Not yet recruiting
PROfiles of FGF-19 Post-prandial Secretion in Older Adults With Frailty and Without Frailty
Frailty, Sarcopenia
Recruiting
Resistance vs Aerobic Prehabilitation Before Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Neoplasms
Recruiting
Effects of a Community-based Multicomponent Physical Exercise Program on Physical Function, Frailty, and Sarcopenia in Older Adults From the Municipality of Santoña: a Quasi-experimental Study.
Frailty/Sarcopenia, Frailty in Older Adults
Not yet recruiting
Creatine and Muscle Health in Madrid's Walking Footballers.
Muscle Adaptation, Body Composition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Figen Yılmaz study chair
Şişli Hamidiye Etfal Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Sarcopenia and Osteoporosis, Osteopenia, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline on Skeletal Muscle Mass Measurement at month 3 (time frame: Baseline and Month 3). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020; AzTrials last refreshed its copy on 27 Oct 2026.