COVID-19NCT05373407
Low Versus Moderate-intensity Aerobic Training in Post-discharge COVID-19 Subjects
A study testing aerobic exercise in people with COVID-19 and Aerobic Exercises, run by University of Hail at 1 site in Saudi Arabia.
Trial summary
The main purpose of this study is to compare the impact of low versus moderate-intensity aerobic training in post-COVID 19 older subjects. On exercise adherence and changes in physical fitness, psychological status, and quality of life after a 10-week intervention. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- COVID-19, Aerobic Exercises, Elderly
- What is being tested?
- aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Aug 2022to 1 Dec 2022
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range of 60 - 80 years with
- diagnosis of post-COVID-19
Who cannot join
- • 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: A Randomized Controlled Trial Examining the Impact of Low Versus Moderate-intensity Aerobic Training in Post-discharge COVID-19 Older Subjects
The main purpose of this study is to compare the impact of low versus moderate-intensity aerobic training in post-COVID 19 older subjects.
On exercise adherence and changes in physical fitness, psychological status, and quality of life after a 10-week intervention.
- Conditions
- COVID-19, Aerobic Exercises, Elderly
- Being tested
- aerobic exercise
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseOther
participants will perform different dosage of the same intervention, one group will perform moderate intensity and the other will perform low intensity aerobic training
| Study group | Role | What they receive |
|---|---|---|
| moderate intensity aerobic training | Experimental | The exercises were conducted at a heart rate of 50-70% of maximum heart rate for 30 minutes. Exercises were included strengthening muscles groups (shoulder flexors, extensors, abductor's muscles, hip flexors, extensor muscles, knee flexors, extensor muscles, abdominal muscles, and back muscles). Receives: Other: aerobic exercise |
| low intensity aerobic training | Experimental | Exercises were performed at 40-50% of the maximum heart rate Starting by 15 minutes of Warm-up time included static stretching of upper and lower body muscles.
After that, participants performed 30 minutes of low-intensity aerobic training exercises, which included 20 minutes on the treadmill, followed by 10 minutes of cooling down.
A set of 5-10 exercises was performed by each muscle group, three sets per exercise were performed, and 10-15 repetitions per series were performed 4 days per week Receives: Other: aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance walked in the 6-min walk test (6 MWT)
The 6-min walk test (6 MWT) measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). (ATS Statement: Guidelines for the Six-Minute Walk Test, Am J Respir Crit Care Med, 2002)
Measured: 8 weeks
Post-Covid Functional Scale (PCFS)
This scale measures the functional state and Independence of patients after COVID-19 infection. The scale includes two items scored from 0-4 and 0-5. A high value indicates more restrictions in function and independence during daily life.
Measured: 8 weeks
Secondary outcomes (3)
Number of repetitions performed in a 1-min Sit-to-Stand (STS) test
All 1-min STS tests are performed according to a standardized protocol by trained study staff. A standard chair is used with a flat seat and no armrests, stabilized against a wall. Patients are asked to sit with their legs hip-width apart and flexed to 90°, with their hands stationary on the hips.
Measured: 8 weeks
2. Anxiety and Depression evaluated by the HAMLITON ScAnxiety and Depressionale (HADS)
Anxiety and Depression evaluated by the HAMLITON ScAnxiety and Depressionale (HADS)
Measured: 8 weeks
Quality of life SF-36
The SF-36 SF was used to evaluate self-reported domains of health status. This questionnaire consists of 36 items compiled into 8 scalesThe SF-36 questionnaire was used to evaluate self-reported domains of health status (Ware and Sherbourne, 1992). This questionnaire consists of 36 items compiled into 8 scales: physical functioning (PF), role functioning/physical (RP), bodily pain (BP), general health (GH), vitality (VT), social funct
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 posted13 May 2022
- Study start15 Aug 2022
- Primary completion30 Oct 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hail
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelmoniem Ibrahim, University of Hail
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373407
- Sponsor's protocol ID
- 00000
- Status last verified
- Dec 2022
- First submitted
- 12 May 2022
- Last updated
- 14 Dec 2022
- 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 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Examining the Impact of Low Versus Moderate-intensity Aerobic Training in Post-discharge COVID-19 Older Subjects
- ClinicalTrials.gov ID
- NCT05373407
- Acronym / sponsor ID
- 00000
- Conditions
- COVID-19, Aerobic Exercises, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of HailUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 13 May 2022 (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 main purpose of this study is to compare the impact of low versus moderate-intensity aerobic training in post-COVID 19 older subjects.
On exercise adherence and changes in physical fitness, psychological status, and quality of life after a 10-week intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| moderate intensity aerobic training | Experimental | Other: aerobic exerciseThe exercises were conducted at a heart rate of 50-70% of maximum heart rate for 30 minutes. Exercises were included strengthening muscles groups (shoulder flexors, extensors, abductor's muscles, hip flexors, extensor muscles, knee flexors, extensor muscles, abdominal muscles, and back muscles). |
| low intensity aerobic training | Experimental | Other: aerobic exerciseExercises were performed at 40-50% of the maximum heart rate Starting by 15 minutes of Warm-up time included static stretching of upper and lower body muscles. After that, participants performed 30 minutes of low-intensity aerobic training exercises, which included 20 minutes on the treadmill, followed by 10 minutes of cooling down. A set of 5-10 exercises was performed by each muscle group, three sets per exercise were performed, and 10-15 repetitions per series were performed 4 days per week |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age range of 60 - 80 years with
- diagnosis of post-COVID-19
Key exclusion criteria (5 listed)
- • History of lower limb surgeries, fractures
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 |
|---|---|---|
| aerobic exerciseparticipants will perform different dosage of the same intervention, one group will perform moderate intensity and the other will perform low intensity aerobic training | Other | low intensity aerobic training, moderate intensity aerobic training |
Primary outcome
Distance walked in the 6-min walk test (6 MWT)
Time frame: 8 weeks
The 6-min walk test (6 MWT) measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). (ATS Statement: Guidelines for the Six-Minute Walk Test, Am J Respir Crit Care Med, 2002)
Post-Covid Functional Scale (PCFS)
Time frame: 8 weeks
This scale measures the functional state and Independence of patients after COVID-19 infection. The scale includes two items scored from 0-4 and 0-5. A high value indicates more restrictions in function and independence during daily life.
3 secondary outcomes
Number of repetitions performed in a 1-min Sit-to-Stand (STS) test
Time frame: 8 weeks
2. Anxiety and Depression evaluated by the HAMLITON ScAnxiety and Depressionale (HADS)
Time frame: 8 weeks
Quality of life SF-36
Time frame: 8 weeks
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 14 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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 aerobic exercise in people with COVID-19 and Aerobic Exercises, run by University of Hail at 1 site in Saudi Arabia.
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 5 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 14 Dec 2022. 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 Saudi Arabia. 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?
Distance walked in the 6-min walk test (6 MWT) (time frame: 8 weeks). The study lists 2 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 14 Dec 2022.