SarcopeniaNCT04796064
Low Versus High-Intensity Aerobic Training in Community-dwelling Older Men With Post-COVID 19 (SARS-CoV-2) Sarcopenia
A study testing low-intensity aerobic training in people with Sarcopenia, run by Cairo University at 1 site in Egypt.
Trial summary
Sarcopenia is the major health concern and common consequence of COVID-19 in the ageing population. The objective of this study is to find and compare low and high-intensity aerobic training protocols on clinical and psychological effects in community-dwelling older men with post-COVID 19 Sarcopenia. Read more about this study
- Who is it for?
- Ages 60 to 80 years, men only
- Conditions the study is for
- Sarcopenia
- What is being tested?
- low-intensity aerobic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2020to 15 Dec 2020
- 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 60 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range of 60 - 80 years with
- A positive diagnosis of post-COVID-19 sarcopenia
Who cannot join
- Under medication
- History of lower limb surgeries, fractures
- Cardiac problems
- Respiratory problems
- Neurological problems
- Systemic problems and any other contraindications for aerobic training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effectiveness Study of Low Versus High-Intensity Aerobic Training in Community-dwelling Older Men With Post-COVID 19 Sarcopenia
Sarcopenia is the major health concern and common consequence of COVID-19 in the ageing population. The objective of this study is to find and compare low and high-intensity aerobic training protocols on clinical and psychological effects in community-dwelling older men with post-COVID 19 Sarcopenia.
- Conditions
- Sarcopenia
- Being tested
- low-intensity aerobic training
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-intensity aerobic trainingOther
A low-intensity aerobic training group started with 15 minutes of warm-up, which includes static stretching of the upper and lower limb muscles. then participants were instructed to do 30 minutes of low-intensity aerobic training exercises, which include 20 minutes on the treadmill and 10 minutes of cycle ergometer, followed by 10 minutes of cool down.
- In high-intensity training (HAT) the same protocol has been followed, but the intensity of exercises was fixed between 60% to 80 % of maximum heart rate. The strength training includes major group muscles such as shoulder flexors, extensors, and abductors, elbow flexors and extensors, hip flexors\& extensors, knee flexors\&extensors, abdominal and back muscles also were trained. Each group of muscles was trained for 10 repetitions for 3 sets with a rest period of 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| low-intensity aerobic training group | Experimental | Not described Receives: Other: low-intensity aerobic training |
| high-intensity aerobic training group | Experimental | Not described Receives: Other: low-intensity aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handgrip strength
It is a simple and cost-effective test to measure the upper limb strength
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start30 Mar 2020
- Primary completion5 Nov 2020
- Study completion15 Dec 2020
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 Cairo 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Eid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796064
- Sponsor's protocol ID
- Sarcopenia
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness Study of Low Versus High-Intensity Aerobic Training in Community-dwelling Older Men With Post-COVID 19 Sarcopenia
- ClinicalTrials.gov ID
- NCT04796064
- Acronym / sponsor ID
- Sarcopenia
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 12 Mar 2021 (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.
Sarcopenia is the major health concern and common consequence of COVID-19 in the ageing population. The objective of this study is to find and compare low and high-intensity aerobic training protocols on clinical and psychological effects in community-dwelling older men with post-COVID 19 Sarcopenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-intensity aerobic training group | Experimental | Other: low-intensity aerobic training |
| high-intensity aerobic training group | Experimental | Other: low-intensity aerobic training |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age range of 60 - 80 years with
- A positive diagnosis of post-COVID-19 sarcopenia
Key exclusion criteria (6 listed)
- Under medication
- History of lower limb surgeries, fractures
- Cardiac problems
- Respiratory problems
- Neurological problems
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 |
|---|---|---|
| low-intensity aerobic trainingA low-intensity aerobic training group started with 15 minutes of warm-up, which includes static stretching of the upper and lower limb muscles. then participants were instructed to do 30 minutes of low-intensity aerobic training exercises, which include 20 minutes on the treadmill and 10 minutes of cycle ergometer, followed by 10 minutes of cool down. - In high-intensity training (HAT) the same protocol has been followed, but the intensity of exercises was fixed between 60% to 80 % of maximum heart rate. The strength training includes major group muscles such as shoulder flexors, extensors, and abductors, elbow flexors and extensors, hip flexors\& extensors, knee flexors\&extensors, abdominal and back muscles also were trained. Each group of muscles was trained for 10 repetitions for 3 sets with a rest period of 5 minutes. | Other | high-intensity aerobic training group, low-intensity aerobic training group |
Primary outcome
Handgrip strength
Time frame: 8 weeks
It is a simple and cost-effective test to measure the upper limb strength
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 12 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-intensity aerobic training in people with Sarcopenia, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 6 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 12 Mar 2021. 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 Egypt. 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?
Handgrip strength (time frame: 8 weeks). 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 12 Mar 2021.