Covid19NCT04871672
Effects of Pilates Exercises on Core Stability After Recovery From COVID -19
A study testing Pilates Exercises and Home Exercise program in people with Covid19 and Pilates, Core Stability, run by University of Jazan at 1 site in Saudi Arabia.
Trial summary
This study will be conducted in the Department of physical therapy, College of Applied Medical Sciences,Jazan University, to Effects of Pilates Exercises on core stability after Recovery from COVID - 19 Read more about this study
- Who is it for?
- Ages 19 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, Pilates, Core Stability
- What is being tested?
- Pilates Exercises and Home Exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 26 Dec 2021to 23 Feb 2023
- 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 19 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Persons who had mild to moderate covid- 19 illness.
- Asymptomatic period of at least seven days (without chest pain, breathlessness).
- No musculoskeletal damage.
- No pregnancy.
- No visually identified asymmetries in the spinal trunk and lower limbs.
- None of the subjects has a history of balance training
- Subjects will not have any diseases of the central nervous system.
- Subjects with body mass index (BMI)<25 kg/m2.
Who cannot join
- Persons who had more severe covid 19 illnesses and were hospitalized.
- Persons who had during their illness chest pain breathlessness, palpitation, symptoms, and signs of heart failure.
- 9. Subjects with cardiopulmonary disorders. 3. A history of previous back or abdominal surgery/injury 4. Evidence of a systemic or musculoskeletal disease within the past six months
- -
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted in the Department of physical therapy, College of Applied Medical Sciences,Jazan University, to Effects of Pilates Exercises on core stability after Recovery from COVID - 19
Read the detailed description
145 male and female students who had infected with covid 19 with age 19 to 26 years old, will be recruited from the College of Applied Medical Sciences, Jazan University. Subjects will be randomly assigned to a pilates and home exercises (PAH) group or a control group who will perform only home exercises (COH)
Four core endurance tests will be performed to assess the core stability
Pilates exercise program will be composed of Pilates mat exercise program for a period of 12 weeks and three sessions every week.
Each session took one hour. Every session started with 10 minutes of simple stretching movements to warm-up followed by the main part of the exercise plan for 40 min, followed by 10 minutes, some cool-down stretching.
When the 12-week study period will over, the core stability will be assessed by the endurance tests and Prokin system for balance
- Conditions
- Covid19, Pilates, Core Stability
- Being tested
- Pilates Exercises, Home Exercise program
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates ExercisesOther
basic five pilates intermediate workout based on the principles of Pilates
Home Exercise programOther
home exercise
| Study group | Role | What they receive |
|---|---|---|
| pilates and home exercises (PAH) group | Experimental | these subjects will receive pilates and home exercises. Receives: Other: Pilates Exercises; Other: Home Exercise program |
| control home exercises group (COH) | Active comparator | these subjects will receive only home exercises. Receives: Other: Home Exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of core stability: endurance capacity of anterior deep trunk muscles
Abdominal fatigue test: is an isometric trunk flexor test
Measured: at the date of the first session and at the last session after 12 weeks
Evaluation of core stability: assesses the functioning of trunk extensor muscles
Sorensen back-extension endurance
Measured: at the date of the first session and at the last session after 12 weeks
Evaluation of core stability: Prone Plank test
Prone Plank test
Measured: at the date of the first session and at the last session after 12 weeks
Evaluation of core stability: Endurance capacity of lateral core muscles particularly the quadrates lumborum
Side Plank Tests
Measured: at the date of the first session and at the last session after 12 weeks
Evaluation of core stability: balance test by Prokin system for perimeter parameter with opened eyes, measured in mm
Eyes Open perimeter (EOPM), measured in mm
Measured: 30 seconds
Evaluation of core stability: balance test by Prokin system for perimeter parameter with closed eyes, measured in mm
Eyes closed perimeter (ECPM), measured in mm
Measured: 30 seconds
Evaluation of core stability: balance test by Prokin system for ellipse area parameter with Opened eyes, measured in mm
Eyes Open ellipse area (EOEA) measured in mm2
Measured: 30 seconds
Evaluation of core stability: balance test by Prokin system for ellipse area parameter with closed eyes, measured in mm
Eyes closed ellipse area (ECEA) measured in mm2
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start26 Dec 2021
- Primary completion24 Oct 2022
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Model description
- Subjects will be randomly assigned to two groups: 1. pilates and home exercises (PAH) group 2. home exercises group (COH)
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jazan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wafaa Mahmoud Amin, University of Jazan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871672
- Sponsor's protocol ID
- Sponsor-Investigator:
- Status last verified
- Oct 2023
- First submitted
- 24 Apr 2021
- Last updated
- 17 Oct 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 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pilates Exercises on Core Stability After Recovery From COVID -19
- ClinicalTrials.gov ID
- NCT04871672
- Acronym / sponsor ID
- Sponsor-Investigator:
- Conditions
- Covid19, Pilates, Core Stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University of JazanOther government
- Study start
- 26 Dec 2021 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 4 May 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.
This study will be conducted in the Department of physical therapy, College of Applied Medical Sciences,Jazan University, to Effects of Pilates Exercises on core stability after Recovery from COVID - 19
Detailed description
145 male and female students who had infected with covid 19 with age 19 to 26 years old, will be recruited from the College of Applied Medical Sciences, Jazan University. Subjects will be randomly assigned to a pilates and home exercises (PAH) group or a control group who will perform only home exercises (COH)
Four core endurance tests will be performed to assess the core stability
Pilates exercise program will be composed of Pilates mat exercise program for a period of 12 weeks and three sessions every week.
Each session took one hour. Every session started with 10 minutes of simple stretching movements to warm-up followed by the main part of the exercise plan for 40 min, followed by 10 minutes, some cool-down stretching.
When the 12-week study period will over, the core stability will be assessed by the endurance tests and Prokin system for balance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomly assigned to two groups: 1. pilates and home exercises (PAH) group 2. home exercises group (COH)
| Arm | Type | Receives |
|---|---|---|
| pilates and home exercises (PAH) group | Experimental | Other: Pilates Exercises, Other: Home Exercise programthese subjects will receive pilates and home exercises. |
| control home exercises group (COH) | Active comparator | Other: Home Exercise programthese subjects will receive only home exercises. |
Who may qualify
- Ages
- 19 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Persons who had mild to moderate covid- 19 illness.
- Asymptomatic period of at least seven days (without chest pain, breathlessness).
- No musculoskeletal damage.
- No pregnancy.
- No visually identified asymmetries in the spinal trunk and lower limbs.
Key exclusion criteria (4 listed)
- Persons who had more severe covid 19 illnesses and were hospitalized.
- Persons who had during their illness chest pain breathlessness, palpitation, symptoms, and signs of heart failure.
- 9. Subjects with cardiopulmonary disorders. 3. A history of previous back or abdominal surgery/injury 4. Evidence of a systemic or musculoskeletal disease within the past six 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 |
|---|---|---|
| Pilates Exercisesbasic five pilates intermediate workout based on the principles of Pilates | Other | pilates and home exercises (PAH) group |
| Home Exercise programhome exercise | Other | control home exercises group (COH), pilates and home exercises (PAH) group |
Primary outcome
Evaluation of core stability: endurance capacity of anterior deep trunk muscles
Time frame: at the date of the first session and at the last session after 12 weeks
Abdominal fatigue test: is an isometric trunk flexor test
Evaluation of core stability: assesses the functioning of trunk extensor muscles
Time frame: at the date of the first session and at the last session after 12 weeks
Sorensen back-extension endurance
Evaluation of core stability: Prone Plank test
Time frame: at the date of the first session and at the last session after 12 weeks
Prone Plank test
Evaluation of core stability: Endurance capacity of lateral core muscles particularly the quadrates lumborum
Time frame: at the date of the first session and at the last session after 12 weeks
Side Plank Tests
Evaluation of core stability: balance test by Prokin system for perimeter parameter with opened eyes, measured in mm
Time frame: 30 seconds
Eyes Open perimeter (EOPM), measured in mm
Evaluation of core stability: balance test by Prokin system for perimeter parameter with closed eyes, measured in mm
Time frame: 30 seconds
Eyes closed perimeter (ECPM), measured in mm
Evaluation of core stability: balance test by Prokin system for ellipse area parameter with Opened eyes, measured in mm
Time frame: 30 seconds
Eyes Open ellipse area (EOEA) measured in mm2
Evaluation of core stability: balance test by Prokin system for ellipse area parameter with closed eyes, measured in mm
Time frame: 30 seconds
Eyes closed ellipse area (ECEA) measured in mm2
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 17 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates Exercises and Home Exercise program in people with Covid19 and Pilates, Core Stability, run by University of Jazan 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 8 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: finished, as of the sponsor's last update on 17 Oct 2023. 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?
Evaluation of core stability: endurance capacity of anterior deep trunk muscles (time frame: at the date of the first session and at the last session after 12 weeks). The study lists 8 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 17 Oct 2023.