COVID-19NCT05496634
The Effect of Pilates on Biopsychosocial Characteristics in the Covid-19 Pandemic
A study testing Sedantary and Exercise therapy in people with COVID-19 and Healthy, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigation of biopsychosocial characteristics of individuals who do pilates and sedentary individuals during the COVID-19 pandemic. The study was carried out with 2 groups: individuals ages 20-50,participating in a pilates program for 8 weeks (n:27) and sedentary individuals (n:27). Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Sedantary and Exercise therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2022to 21 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 20-50, without any known neurological, mental, vestibular or orthopedic disease,
- For the exercise group, doing reformer pilates 2 days a week for 8 weeks,
- For the control group, who is not involved in any physical activity in their daily life (sedentary),
- Individuals with at least 2 doses of covid-19 vaccine
Who cannot join
- Having orthopedic, neurological or musculoskeletal system problems that prevent him from doing reformer pilates,
- Not attending the sessions regularly,
- Pregnancy status or suspected,
- Covid-19 positive participants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Biopsychosocial Characteristics of Individuals Doing Pilates and Sedentary Individuals During the Covid-19 Pandemic Process
The aim of this study is to investigation of biopsychosocial characteristics of individuals who do pilates and sedentary individuals during the COVID-19 pandemic. The study was carried out with 2 groups: individuals ages 20-50,participating in a pilates program for 8 weeks (n:27) and sedentary individuals (n:27). Before starting this study, the groups were assessed for biopsychosocial status with the Cognitive Exercise Therapy Approach- Biopsychosocial Questionnaire (CETA-BQ) , for depression levels with the Beck Depression Inventory (BDI), for covid-19 fear levels with the Coronavirus Anxiety Scale, for their sleep quality with the Pittsburg Sleep Quality Index (PSQI), quality of life was assessed with the Nottingham Health Profile (NHP). After the first evaluation, an informative presentation emphasizing the importance of physical activity during the pandemic process was given to all participants. Individuals in the exercise group also participated in pilates sessions that lasted 50 minutes, 2 days a week for 8 weeks. At the end of 8 weeks, all questionnaires were repeated for both groups.
Read the detailed description
Coronavirus disease-2019 (COVID-19); It is an infection that emerged in China in December 2019 and then turned into a pandemic, and it still continues to be seen all over the world. After the first case was seen in our country, the government took measures to slow down the coronavirus epidemic and protect the health of the society. While these measures physically affect people's lives, they limited people's range of motion and reduced their physical activity levels. In early March 2020, researchers predicted that social distancing, along with school closures and restrictions, could result in less physical activity, prolonged sedentary behavior, and poor sleep quality. In a study comparing physical activity behaviors before and during isolation as a result of COVID-19, it was shown that COVID-19 isolations cause a negative effect on all physical activity levels and cause more than 28% increase in daily sitting times.
In addition to the physical effects of the coronavirus, there are also psychological effects. Its psychological effects are not limited to individuals infected with the virus, but are also seen in individuals who are not infected. The COVID-19 epidemic, which is accepted as a stress factor, is associated with the concept of death in most individuals due to the disease, the fear of being infected with the virus and the tendency to take extra precautions, the anxiety of transmitting the virus to others, the fear of death, the state of irritability, attention and concentration disorder. Reactions such as fatigue, sleep disturbance, conflict with family members and social withdrawal are also observed. Deterioration of sleep quality facilitates the spread of infectious diseases and negatively affects the mental health and quality of life of individuals. In addition, the frequent pronunciation of the words social distance, isolation and contact in the society has led to the emergence of a new fear, which is expressed in different terms such as "coronaphobia" or "fear of COVID-19".
Physically active individuals generally experience less stress, depression, and anxiety. Studies show that physical activity strengthens the immune system by increasing the number of immune cells in our body. Exercises that can be applied everywhere, such as walking at home, walking to the market by taking protective measures against the disease, sitting on a chair, climbing stairs, pilates and yoga can be counted as examples of the types of exercises that can be done during quarantine periods.
The Pilates exercise method was created by Joseph Pilates in the 1920s and its original name is "Contrology". Pilates method; It is an exercise system that has the principles of concentration, centering, control, precision in movements, movement flow and breathing dynamics (11). Exercises; It is made on a mat or with special equipment with adjustable spring resistance (12). During the First World War, Joseph Pilates began experimenting with spring mattresses to help treat the war-wounded and attached springs to the ends of mattresses to allow patients to exercise against resistance while tied to the bed. He noticed that exercises with resistance improved muscle tone in patients faster than exercises without resistance. As a result, Joseph Pilates developed the Universal Reformer, a sliding platform with springs on which one can sit, lean or stand, and the Cadillac, a mattress with springs on all four sides (13).
No study has been found in the literature examining the biopsychosocial characteristics of pilates and sedentary individuals during the COVID-19 pandemic. In this context, in our study; The biopsychosocial characteristics of individuals doing pilates and sedentary individuals during the COVID-19 pandemic were examined.
- Being tested
- Sedantary, Exercise therapy
- Medical subject headings
- COVID-19, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SedantaryBehavioural
An informative presentation
Exercise therapyBehavioural
Pilates exercise therapy
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | An informative presentation will be made emphasizing the importance of physical activity during the pandemic process. Individuals in the exercise group also participated in pilates sessions that lasted 50 minutes, 2 days a week for 8 weeks. Receives: Behavioral: Exercise therapy |
| Control Group | Experimental | An informative presentation will be made emphasizing the importance of physical activity during the pandemic process. Receives: Behavioral: Sedantary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Exercise Therapy Approach- Biopsychosocial Questionnaire (CETA-BQ)
It was used to evaluate the biopsychosocial status of the participants. Each item is scored between 0-4 according to the Likert system. An increase in the score indicates a worsening of the biopsychosocial status. (4: Yes always, 3: Yes often, 2: Yes sometimes, 1: Yes rarely, 0: No, never)
Measured: 0-8 weeks
Beck Depression Inventory (BDI)
Beck Depression Scale consists of 21 items including depressive symptoms. Minimal depression from 0 to 9 points; 10-16 points mild depression; 17-29 points indicate moderate depression and 30-63 points indicate severe depression.
Measured: 0-8 weeks
Coronavirus Anxiety Scale
The scale was created by evaluating the scales evaluating different fear parameters by experts and taking into account the opinions of the participants. The scale is scored in a one-factor and five-point Likert type (1=I strongly disagree; 5=I strongly agree). The scale consists of seven items. The score that can be obtained from the scale is between 7-35. A high score indicates greater fear of COVID-19.
Measured: 0-8 weeks
Pittsburg Sleep Quality Index (PSQI)
The PSQI consists of 7 components: 1. subjective sleep quality, 2. sleep latency, 3. sleep duration, 4. habitual sleep efficiency, 5. sleep disturbance, 6. sleep medication use, 7. daytime dysfunction. Each component is evaluated with a score between 0-3. The total score is between 0-21. A higher score indicates worsening sleep quality. A score of 0-4 is considered good sleep quality, while a score of 5-21 is defined as poor sleep quality.
Measured: 0-8 weeks
Nottingham Health Profile (NHP)
Questionnaire; pain (8 items), physical activity (8 items), energy (3 items), sleep (5 items), social isolation (5 items) and emotional reaction (9 items). There are 38 questions in total. Questions are answered with yes or no. Each section is scored between 0-100. Zero indicates best health, 100 indicates worst health.
Measured: 0-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start5 Jan 2022
- Primary completion12 Dec 2022
- Study completion21 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.
- More trials run by Medipol 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Controlled study
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülay Aras, Medipol University
- Investigators
- Gülay Aras Bayram, PhD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496634
- Sponsor's protocol ID
- E-10840098-772.02-840
- Status last verified
- Dec 2022
- First submitted
- 5 Aug 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Biopsychosocial Characteristics of Individuals Doing Pilates and Sedentary Individuals During the Covid-19 Pandemic Process
- ClinicalTrials.gov ID
- NCT05496634
- Acronym / sponsor ID
- E-10840098-772.02-840
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 11 Aug 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 aim of this study is to investigation of biopsychosocial characteristics of individuals who do pilates and sedentary individuals during the COVID-19 pandemic. The study was carried out with 2 groups: individuals ages 20-50,participating in a pilates program for 8 weeks (n:27) and sedentary individuals (n:27). Before starting this study, the groups were assessed for biopsychosocial status with the Cognitive Exercise Therapy Approach- Biopsychosocial Questionnaire (CETA-BQ) , for depression levels with the Beck Depression Inventory (BDI), for covid-19 fear levels with the Coronavirus Anxiety Scale, for their sleep quality with the Pittsburg Sleep Quality Index (PSQI), quality of life was assessed with the Nottingham Health Profile (NHP). After the first evaluation, an informative presentation emphasizing the importance of physical activity during the pandemic process was given to all participants. Individuals in the exercise group also participated in pilates sessions that lasted 50 minutes, 2 days a week for 8 weeks. At the end of 8 weeks, all questionnaires were repeated for both groups.
Detailed description
Coronavirus disease-2019 (COVID-19); It is an infection that emerged in China in December 2019 and then turned into a pandemic, and it still continues to be seen all over the world. After the first case was seen in our country, the government took measures to slow down the coronavirus epidemic and protect the health of the society. While these measures physically affect people's lives, they limited people's range of motion and reduced their physical activity levels. In early March 2020, researchers predicted that social distancing, along with school closures and restrictions, could result in less physical activity, prolonged sedentary behavior, and poor sleep quality. In a study comparing physical activity behaviors before and during isolation as a result of COVID-19, it was shown that COVID-19 isolations cause a negative effect on all physical activity levels and cause more than 28% increase in daily sitting times.
In addition to the physical effects of the coronavirus, there are also psychological effects. Its psychological effects are not limited to individuals infected with the virus, but are also seen in individuals who are not infected. The COVID-19 epidemic, which is accepted as a stress factor, is associated with the concept of death in most individuals due to the disease, the fear of being infected with the virus and the tendency to take extra precautions, the anxiety of transmitting the virus to others, the fear of death, the state of irritability, attention and concentration disorder. Reactions such as fatigue, sleep disturbance, conflict with family members and social withdrawal are also observed. Deterioration of sleep quality facilitates the spread of infectious diseases and negatively affects the mental health and quality of life of individuals. In addition, the frequent pronunciation of the words social distance, isolation and contact in the society has led to the emergence of a new fear, which is expressed in different terms such as "coronaphobia" or "fear of COVID-19".
Physically active individuals generally experience less stress, depression, and anxiety. Studies show that physical activity strengthens the immune system by increasing the number of immune cells in our body. Exercises that can be applied everywhere, such as walking at home, walking to the market by taking protective measures against the disease, sitting on a chair, climbing stairs, pilates and yoga can be counted as examples of the types of exercises that can be done during quarantine periods.
The Pilates exercise method was created by Joseph Pilates in the 1920s and its original name is "Contrology". Pilates method; It is an exercise system that has the principles of concentration, centering, control, precision in movements, movement flow and breathing dynamics (11). Exercises; It is made on a mat or with special equipment with adjustable spring resistance (12). During the First World War, Joseph Pilates began experimenting with spring mattresses to help treat the war-wounded and attached springs to the ends of mattresses to allow patients to exercise against resistance while tied to the bed. He noticed that exercises with resistance improved muscle tone in patients faster than exercises without resistance. As a result, Joseph Pilates developed the Universal Reformer, a sliding platform with springs on which one can sit, lean or stand, and the Cadillac, a mattress with springs on all four sides (13).
No study has been found in the literature examining the biopsychosocial characteristics of pilates and sedentary individuals during the COVID-19 pandemic. In this context, in our study; The biopsychosocial characteristics of individuals doing pilates and sedentary individuals during the COVID-19 pandemic were examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Controlled study
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: Exercise therapyAn informative presentation will be made emphasizing the importance of physical activity during the pandemic process. Individuals in the exercise group also participated in pilates sessions that lasted 50 minutes, 2 days a week for 8 weeks. |
| Control Group | Experimental | Behavioral: SedantaryAn informative presentation will be made emphasizing the importance of physical activity during the pandemic process. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between the ages of 20-50, without any known neurological, mental, vestibular or orthopedic disease,
- For the exercise group, doing reformer pilates 2 days a week for 8 weeks,
- For the control group, who is not involved in any physical activity in their daily life (sedentary),
- Individuals with at least 2 doses of covid-19 vaccine
Key exclusion criteria (4 listed)
- Having orthopedic, neurological or musculoskeletal system problems that prevent him from doing reformer pilates,
- Not attending the sessions regularly,
- Pregnancy status or suspected,
- Covid-19 positive participants
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 |
|---|---|---|
| SedantaryAn informative presentation | Behavioural | Control Group |
| Exercise therapyPilates exercise therapy | Behavioural | Exercise Group |
Primary outcome
Cognitive Exercise Therapy Approach- Biopsychosocial Questionnaire (CETA-BQ)
Time frame: 0-8 weeks
It was used to evaluate the biopsychosocial status of the participants. Each item is scored between 0-4 according to the Likert system. An increase in the score indicates a worsening of the biopsychosocial status. (4: Yes always, 3: Yes often, 2: Yes sometimes, 1: Yes rarely, 0: No, never)
Beck Depression Inventory (BDI)
Time frame: 0-8 weeks
Beck Depression Scale consists of 21 items including depressive symptoms. Minimal depression from 0 to 9 points; 10-16 points mild depression; 17-29 points indicate moderate depression and 30-63 points indicate severe depression.
Coronavirus Anxiety Scale
Time frame: 0-8 weeks
The scale was created by evaluating the scales evaluating different fear parameters by experts and taking into account the opinions of the participants. The scale is scored in a one-factor and five-point Likert type (1=I strongly disagree; 5=I strongly agree). The scale consists of seven items. The score that can be obtained from the scale is between 7-35. A high score indicates greater fear of COVID-19.
Pittsburg Sleep Quality Index (PSQI)
Time frame: 0-8 weeks
The PSQI consists of 7 components: 1. subjective sleep quality, 2. sleep latency, 3. sleep duration, 4. habitual sleep efficiency, 5. sleep disturbance, 6. sleep medication use, 7. daytime dysfunction. Each component is evaluated with a score between 0-3. The total score is between 0-21. A higher score indicates worsening sleep quality. A score of 0-4 is considered good sleep quality, while a score of 5-21 is defined as poor sleep quality.
Nottingham Health Profile (NHP)
Time frame: 0-8 weeks
Questionnaire; pain (8 items), physical activity (8 items), energy (3 items), sleep (5 items), social isolation (5 items) and emotional reaction (9 items). There are 38 questions in total. Questions are answered with yes or no. Each section is scored between 0-100. Zero indicates best health, 100 indicates worst health.
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 22 Dec 2022.
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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.
Gülay Aras Bayram, PhD principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedantary and Exercise therapy in people with COVID-19 and Healthy, run by Medipol University 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 4 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 22 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 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?
Cognitive Exercise Therapy Approach- Biopsychosocial Questionnaire (CETA-BQ) (time frame: 0-8 weeks). The study lists 5 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 22 Dec 2022.