ExerciseNCT05317650
Effects Multi-Gravitational Suspension-Based Therapy
A study testing Multi-gravitational suspension-based therapy (M-Gravity) in people with Exercise, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
Background: Multi-gravitational suspension-based therapy (M-Gravity) is a comprehensive discipline based on the principles of non-gravity, which serves to increase the quality of life and holistic health of the individual with the rehabilitation content of non-pressure inversion therapy. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Multi-gravitational suspension-based therapy (M-Gravity)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 28 Feb 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sedentary women
Who cannot join
- Individuals with a physical, cardiac, or neurological disease that may interfere with our practices and assessments
- Pregnancy and post-natal individuals
- Individuals with scoliosis of 20 degrees or more
- Glaucoma
- Recent surgery (3-6 months waiting period according to surgery)
- Hypertension, exercise in the head-down position can cause an increase in blood pressure and a hypertensive crisis
Show all 16Show fewer
- Impaired cerebral circulation
- Botox treatment in the last 6 hours
- Spinal fractures
- Severe osteoporosis
- Sequestered disc herniation
- Spinal tumors
- Inflammatory conditions of the spine
- Head injuries
- Previous myocardial infarction
- Vertigo
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Multi-Gravitational Suspension-Based Therapy on Posture, Physical Fitness, Quality of Life, Depression, and Sleep Quality in Women Without Regular Exercise Habits
Background: Multi-gravitational suspension-based therapy (M-Gravity) is a comprehensive discipline based on the principles of non-gravity, which serves to increase the quality of life and holistic health of the individual with the rehabilitation content of non-pressure inversion therapy.
Aims: To examine the effects of M-Gravity exercise on posture, physical fitness, quality of life, depression, and sleep quality in women without regular exercise habits.
Methods: This study was designed as a non-randomized controlled trial. This study included 20 women without regular exercise habits, who participated in the exercise with M-Gravity and 20 women who did not participate in any exercise program, a total of 40 participants. In this study, the investigators planned to evaluate the effects of M-Gravity on women without regular exercise habits. The following outcomes were measured: posture with the New York Posture Assessment Method, the flexibility of the hamstring and pectoral muscles, time is taken to stay in the plank position, depression levels with the Beck Depression Inventory scale, sleep quality is performed with the Pittsburgh Sleep Quality Index, and the Nottingham Health Profile (NHP) questionnaire to measure the perceived health levels of the subjects. The measurement of the contraction force of the deep lumbar muscles is performed with the Stabilizer Pressure Biofeedback (Chattanooga Stabilizer). Two evaluations were made before and after 4 weeks of exercise.
- Conditions
- Exercise
- Being tested
- Multi-gravitational suspension-based therapy (M-Gravity)
- Keywords
- woman, exercise, posture, physical fitness, quality of life
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-gravitational suspension-based therapy (M-Gravity)Other
Multi-gravitational suspension-based therapy (M-Gravity) is a comprehensive discipline based on the principles of non-gravity, which serves to increase the quality of life and holistic health of the individual with the rehabilitation content of non-pressure inversion therapy.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Control group, no exercise was performed, and the measurements were repeated at the end of 4 weeks. |
| M-Gravity group | Experimental | Intervention group performed the exercise with the M-Gravity, 2 sessions per week, for 4 weeks, at the Outpatient Clinic of Department of Physical Therapy, Baskent University, one session for 60 minutes. Receives: Other: Multi-gravitational suspension-based therapy (M-Gravity) |
What is being measured
The primary outcome is the main question the study is designed to answer.
New York Posture Assessment Method
The posture of the subjects participating in the study was evaluated with the New York Posture Assessment Method (NYPDY). In this evaluation system, postural changes that may occur in 13 different parts of the body were monitored and scored. Accordingly, five (5) points were given if the person's posture was correct, three (3) points if moderately impaired, and one (1) point if severely impaired. The total score obtained as a result of the test is a maximum of 65 and a minimum of 13. Standard evaluation criteria developed for this test were defined as "very good" if the total score is >=45, "good" if the score is 40-44, "moderate" if the score is 30-39, "fair" if the score is 20-29, and "poor" if the score is <=19
Measured: 4 weeks
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index, includes 19 questions and consists of seven items evaluating subjective sleep quality, sleep delay, sleep duration, sleep efficiency, sleep disturbance, use of sleeping pills, and impairment in daytime work. The response of each is scored between 0-3 according to symptom frequency. Scoring; 0 if it has never happened during the past month, 1 if it is less than once a week, 2 if it is once or twice a week, and 3 if it is three or more times a week. The sleep quality assessment asked in the questionnaire is; It is scored as 0 very good, 1 fairly good, 2 very badly, and 3 very badly. The obtained global score ranges from 0 to 21, and high values indicate poor sleep quality and high level of sleep disturbance. A global score of 5 or above indicates that the quality of sleep is clinically significantly worse.
Measured: 4 weeks
Nottingham Health Profile
The 'Nottingham Health Profile is a general quality of life questionnaire that measures the perceived health problems of the person and the extent to which these problems affect normal daily activities. The questionnaire consists of 38 items. Questions are answered as 'yes' or 'no'. The questionnaire assesses six parameters related to health status. These parameters are; pain (8 items), physical activity (8 items), energy (3 items), sleep (5 items), social isolation (5 items), emotional reactions (9 items). Each sub-parameter is scored between 0-100. 0 indicates best health, 100 indicates worst health.
Measured: 4 weeks
Stabilizer Pressure Biofeedback
The measurement of the contraction force of the deep lumbar muscles is performed with the "Stabilizer Pressure Biofeedback" (Chattanooga Stabilizer). Before the test, each patient is taught how to tighten the Transversus Abdominous with the corset method in the supine and quadrupedal position. Subjects will be placed face down on an inflated pillow attached to a manometer
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 Sep 2021
- Primary completion31 Jan 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aybuke Ersin, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317650
- Sponsor's protocol ID
- 21/128
- Status last verified
- Mar 2022
- First submitted
- 2 Mar 2022
- Last updated
- 8 Apr 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 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Multi-Gravitational Suspension-Based Therapy on Posture, Physical Fitness, Quality of Life, Depression, and Sleep Quality in Women Without Regular Exercise Habits
- ClinicalTrials.gov ID
- NCT05317650
- Acronym / sponsor ID
- 21/128
- Conditions
- Exercise
- Keywords
- woman, exercise, posture, physical fitness, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 8 Apr 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.
Background: Multi-gravitational suspension-based therapy (M-Gravity) is a comprehensive discipline based on the principles of non-gravity, which serves to increase the quality of life and holistic health of the individual with the rehabilitation content of non-pressure inversion therapy.
Aims: To examine the effects of M-Gravity exercise on posture, physical fitness, quality of life, depression, and sleep quality in women without regular exercise habits.
Methods: This study was designed as a non-randomized controlled trial. This study included 20 women without regular exercise habits, who participated in the exercise with M-Gravity and 20 women who did not participate in any exercise program, a total of 40 participants. In this study, the investigators planned to evaluate the effects of M-Gravity on women without regular exercise habits. The following outcomes were measured: posture with the New York Posture Assessment Method, the flexibility of the hamstring and pectoral muscles, time is taken to stay in the plank position, depression levels with the Beck Depression Inventory scale, sleep quality is performed with the Pittsburgh Sleep Quality Index, and the Nottingham Health Profile (NHP) questionnaire to measure the perceived health levels of the subjects. The measurement of the contraction force of the deep lumbar muscles is performed with the Stabilizer Pressure Biofeedback (Chattanooga Stabilizer). Two evaluations were made before and after 4 weeks of exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Control group, no exercise was performed, and the measurements were repeated at the end of 4 weeks. |
| M-Gravity group | Experimental | Other: Multi-gravitational suspension-based therapy (M-Gravity)Intervention group performed the exercise with the M-Gravity, 2 sessions per week, for 4 weeks, at the Outpatient Clinic of Department of Physical Therapy, Baskent University, one session for 60 minutes. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Sedentary women
Key exclusion criteria (16 listed)
- Individuals with a physical, cardiac, or neurological disease that may interfere with our practices and assessments
- Pregnancy and post-natal individuals
- Individuals with scoliosis of 20 degrees or more
- Glaucoma
- Recent surgery (3-6 months waiting period according to surgery)
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 |
|---|---|---|
| Multi-gravitational suspension-based therapy (M-Gravity)Multi-gravitational suspension-based therapy (M-Gravity) is a comprehensive discipline based on the principles of non-gravity, which serves to increase the quality of life and holistic health of the individual with the rehabilitation content of non-pressure inversion therapy. | Other | M-Gravity group |
Primary outcome
New York Posture Assessment Method
Time frame: 4 weeks
The posture of the subjects participating in the study was evaluated with the New York Posture Assessment Method (NYPDY). In this evaluation system, postural changes that may occur in 13 different parts of the body were monitored and scored. Accordingly, five (5) points were given if the person's posture was correct, three (3) points if moderately impaired, and one (1) point if severely impaired. The total score obtained as a result of the test is a maximum of 65 and a minimum of 13. Standard evaluation criteria developed for this test were defined as "very good" if the total score is >=45, "good" if the score is 40-44, "moderate" if the score is 30-39, "fair" if the score is 20-29, and "poor" if the score is <=19
Pittsburgh Sleep Quality Index
Time frame: 4 weeks
The Pittsburgh Sleep Quality Index, includes 19 questions and consists of seven items evaluating subjective sleep quality, sleep delay, sleep duration, sleep efficiency, sleep disturbance, use of sleeping pills, and impairment in daytime work. The response of each is scored between 0-3 according to symptom frequency. Scoring; 0 if it has never happened during the past month, 1 if it is less than once a week, 2 if it is once or twice a week, and 3 if it is three or more times a week. The sleep quality assessment asked in the questionnaire is; It is scored as 0 very good, 1 fairly good, 2 very badly, and 3 very badly. The obtained global score ranges from 0 to 21, and high values indicate poor sleep quality and high level of sleep disturbance. A global score of 5 or above indicates that the quality of sleep is clinically significantly worse.
Nottingham Health Profile
Time frame: 4 weeks
The 'Nottingham Health Profile is a general quality of life questionnaire that measures the perceived health problems of the person and the extent to which these problems affect normal daily activities. The questionnaire consists of 38 items. Questions are answered as 'yes' or 'no'. The questionnaire assesses six parameters related to health status. These parameters are; pain (8 items), physical activity (8 items), energy (3 items), sleep (5 items), social isolation (5 items), emotional reactions (9 items). Each sub-parameter is scored between 0-100. 0 indicates best health, 100 indicates worst health.
Stabilizer Pressure Biofeedback
Time frame: 4 weeks
The measurement of the contraction force of the deep lumbar muscles is performed with the "Stabilizer Pressure Biofeedback" (Chattanooga Stabilizer). Before the test, each patient is taught how to tighten the Transversus Abdominous with the corset method in the supine and quadrupedal position. Subjects will be placed face down on an inflated pillow attached to a manometer
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 8 Apr 2022.
- Individual participant dataSharing planned: No
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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 Multi-gravitational suspension-based therapy (M-Gravity) in people with Exercise, run by Atlas 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 1 inclusion and 16 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 8 Apr 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?
New York Posture Assessment Method (time frame: 4 weeks). The study lists 4 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 8 Apr 2022.