SarcopeniaNCT05705934
Investigation of The Effects of Holistic Group Exercise Program on Muscle Thickness and Physical Performance in Older Adults With Sarcopenia
A study testing Exercise in people with Sarcopenia, run by Ondokuz Mayıs University.
Trial summary
A decrease in muscle mass and function can cause the development of many chronic diseases, including sarcopenia. It has been reported that the best intervention for sarcopenia is exercise. Despite this, the optimal type of exercise for sarcopenia has not yet been determined. Read more about this study
- Who is it for?
- Ages 65 to 105 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2023to 30 Nov 2024
- 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 65 to 105 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Being over the age of 65
- Getting a diagnosis of sarcopenia
- To be able to walk at least 10 meters independently in public
- Getting a score of 4 and above from the clock drawing test
- Volunteer individuals
Who cannot join
- Having a neurological disease
- Having an uncontrollable cardiopulmonary disease
- Acute illness that will prevent him/her from understanding and performing the exercises to be performed status or the presence of significant cognitive impairment
- Providing continuity for less than 80% of the exercise program
About this study
A decrease in muscle mass and function can cause the development of many chronic diseases, including sarcopenia. It has been reported that the best intervention for sarcopenia is exercise. Despite this, the optimal type of exercise for sarcopenia has not yet been determined. Although the holistic approach is used in the literature in the elderly population, it is noticeable that it does not find much space for itself in this patient group. In this study, it was aimed to examine the effects of holistic approach-based exercise program on individuals with sarcopenia.
- Conditions
- Sarcopenia
- Being tested
- Exercise
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Each session of the exercise program will last 50 minutes and will consist of 4 stages. At these stages, it is aimed to work the social, physical, spiritual and mental parameters of the holistic approach.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants in this group will receive holistic-based group exercise program. All evaluations in this group will be done in the form of before and after. The exercise program will be applied for 12 weeks, 3 days a week. Receives: Other: Exercise |
| Group 2 | No intervention | Participants in this group will continue their routine habits and nutrition programs. All assessments in this group will be done in the form of before and after. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Mass
Muscle ultrasound (US) is a feasible and practical tool to predict sarcopenia. It provides scope for the efficient assessment of muscle quality whilst providing insight into the pathophysiology of sarcopenia in addition to the diagnosis of low muscle mass. US has distinct advantages over other available modalities for muscle mass because the tool allows for separate measurements of individual muscle groups in addition to being safe and portable.
Measured: Change from baseline at 12 weeks
The Timed Up&Go Test
It is a balance test used in the evaluation of functional mobility in the elderly. In the timed up and go (TUG) test, subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again. The elapsed time in this sequence is recorded in seconds. Patients wear their regular footwear and can use a walking aid, if needed.
Measured: Change from baseline at 12 weeks
Short Physical Performance Battery (SPPB)
The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. The scores range from 0 (worst performance) to 12 (best performance). A patient's score below 10 is the inclusion criterion for sarcopenia.
Measured: Change from baseline at 12 weeks
Secondary outcomes (7)
SARC-F Questionnaire
There are 5 SARC-F components: Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls. The scores range from 0 to 10, with 0 to 2 points for each component. A score equal to or greater than 4 is predictive of sarcopenia and poor outcome.
Measured: Change from baseline at 12 weeks
Charlson Comorbidity Index
The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis codes found in administrative data. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use.
Measured: Change from baseline at 12 weeks
30-Second Chair Stand Test
The 30 Second Sit to Stand Test is also known as 30 second chair stand test ( 30CST), is for testing leg strength and endurance in older adults. In the middle part of the chair, the person's back is upright, his feet are pressed to the floor and his arms it is ensured that he sits diagonally in front of his chest (right hand on the left shoulder, left hand on the right shoulder). While the person is in this position, he starts the test with the start command and does it as fully as he can for 30 seconds he takes off; the exact number of departures he has made during 30 seconds constitutes the person's score. Scores less than 10 indicate poor muscle endurance.
Measured: Change from baseline at 12 weeks
Hand Grip Strength
It is a method that provides reliable information about upper extremity muscle strength. Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength. It is most useful when multiple measurements are taken over time to track performance.
Measured: Change from baseline at 12 weeks
Berg Balance Test
The BBS consists of 14 different items that evaluate sitting, standing, and dynamic balance in a hierarchical manner and are assigned scores of 0 to 4, with 0 indicating that an individual is unable to complete the task entirely. The BBS comprises the following tasks: sit to stand; standing without support; sitting without support; stand to sit; transfers; standing with eyes closed; the Romberg test with eyes open; functional reach in standing; picking up something off the floor; turning and looking behind; a 360° turn to the right and left; toe touches to a stool; the sharpened Romberg test; and single-leg stance. A high score indicates good balance.
Measured: Change from baseline at 12 weeks
Depression
The 15-item geriatric depression scale (GDS-15) is a short form of GDS and is used to screen, diagnose, and evaluate depression in elderly individuals. The cut-off point of the scale is 7 points and above.
Measured: Change from baseline at 12 weeks
Mini Nutritional Assessment (MNA)
The Mini Nutritional Assessment (MNA) has recently been designed and validated to provide a single, rapid assessment of nutritional status in elderly patients in outpatient clinics, hospitals, and nursing homes. The MNA test is composed of simple measurements and brief questions that can be completed in about 10 min. In the test with a total score of 30, below 17 points is considered as significant malnutrition.
Measured: Change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start30 Mar 2023 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
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.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Yildirim Beyazıt University
- Responsible party
- Principal investigator, Kübra Tuz, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705934
- Sponsor's protocol ID
- 2022-1268
- Status last verified
- Jan 2023
- First submitted
- 20 Jan 2023
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of The Effects of Holistic Group Exercise Program on Muscle Thickness and Physical Performance in Older Adults With Sarcopenia
- ClinicalTrials.gov ID
- NCT05705934
- Acronym / sponsor ID
- 2022-1268
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Collaborators
- Ankara Yildirim Beyazıt University
- Study start
- 30 Mar 2023 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 31 Jan 2023 (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.
A decrease in muscle mass and function can cause the development of many chronic diseases, including sarcopenia. It has been reported that the best intervention for sarcopenia is exercise. Despite this, the optimal type of exercise for sarcopenia has not yet been determined. Although the holistic approach is used in the literature in the elderly population, it is noticeable that it does not find much space for itself in this patient group. In this study, it was aimed to examine the effects of holistic approach-based exercise program on individuals with sarcopenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: ExerciseParticipants in this group will receive holistic-based group exercise program. All evaluations in this group will be done in the form of before and after. The exercise program will be applied for 12 weeks, 3 days a week. |
| Group 2 | No intervention | –Participants in this group will continue their routine habits and nutrition programs. All assessments in this group will be done in the form of before and after. |
Who may qualify
- Ages
- 65 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Being over the age of 65
- Getting a diagnosis of sarcopenia
- To be able to walk at least 10 meters independently in public
- Getting a score of 4 and above from the clock drawing test
- Volunteer individuals
Key exclusion criteria (4 listed)
- Having a neurological disease
- Having an uncontrollable cardiopulmonary disease
- Acute illness that will prevent him/her from understanding and performing the exercises to be performed status or the presence of significant cognitive impairment
- Providing continuity for less than 80% of the exercise program
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 |
|---|---|---|
| ExerciseEach session of the exercise program will last 50 minutes and will consist of 4 stages. At these stages, it is aimed to work the social, physical, spiritual and mental parameters of the holistic approach. | Other | Group 1 |
Primary outcome
Muscle Mass
Time frame: Change from baseline at 12 weeks
Muscle ultrasound (US) is a feasible and practical tool to predict sarcopenia. It provides scope for the efficient assessment of muscle quality whilst providing insight into the pathophysiology of sarcopenia in addition to the diagnosis of low muscle mass. US has distinct advantages over other available modalities for muscle mass because the tool allows for separate measurements of individual muscle groups in addition to being safe and portable.
The Timed Up&Go Test
Time frame: Change from baseline at 12 weeks
It is a balance test used in the evaluation of functional mobility in the elderly. In the timed up and go (TUG) test, subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again. The elapsed time in this sequence is recorded in seconds. Patients wear their regular footwear and can use a walking aid, if needed.
Short Physical Performance Battery (SPPB)
Time frame: Change from baseline at 12 weeks
The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. The scores range from 0 (worst performance) to 12 (best performance). A patient's score below 10 is the inclusion criterion for sarcopenia.
7 secondary outcomes
SARC-F Questionnaire
Time frame: Change from baseline at 12 weeks
Charlson Comorbidity Index
Time frame: Change from baseline at 12 weeks
30-Second Chair Stand Test
Time frame: Change from baseline at 12 weeks
Hand Grip Strength
Time frame: Change from baseline at 12 weeks
Berg Balance Test
Time frame: Change from baseline at 12 weeks
Depression
Time frame: Change from baseline at 12 weeks
Mini Nutritional Assessment (MNA)
Time frame: Change from baseline at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Sarcopenia, run by Ondokuz Mayıs University.
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 4 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: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Muscle Mass (time frame: Change from baseline at 12 weeks). The study lists 3 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 31 Jan 2023.