Pain SyndromeNCT05811455
Comparative Effects of Aerobic Exercises and Progressive Muscle Relaxation Exercises on Pain and Quality of Life
A study testing Aerobic exercises and Progressive muscle relaxation in people with Pain Syndrome and Anxiety, run by Riphah International University at 1 site in Pakistan.
Trial summary
Premenstrual syndrome is the clinical condition in which reproductive age females suffer from emotional and physical symptoms not related to any disease, starting usually 5 days before the menstrual cycle for 3 consecutive cycles. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Syndrome, Anxiety
- What is being tested?
- Aerobic exercises and Progressive muscle relaxation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Nov 2022to 30 Jan 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 to 40 years
- Females in their last week of the luteal phase (1 week before menstruation)
- Females with regular menstrual with equal intervals between 21 and 35 days
- Females with a score of 133 and above after being screened with Premenstrual syndrome scale
- Females suffering from PMS for at least the past six months
Who cannot join
- Females with the irregular menstrual cycle
- Pregnant females
- Menstruating females or females in the follicular or ovulatory phase
- History of physical exercise in the past three months before the beginning of the study
- Females suffering from other gynecological issues such as endometriosis, PCOS, uterine or cervical cancer
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Johar Institute of Professional Studies
Lahore, Punjab Province
About this study
Official title: Comparative Effects of Aerobic Exercises and Progressive Muscle Relaxation Exercises on Pain,Anxiety and Quality of Life
Premenstrual syndrome is the clinical condition in which reproductive age females suffer from emotional and physical symptoms not related to any disease, starting usually 5 days before the menstrual cycle for 3 consecutive cycles.
Read the detailed description
Premenstrual syndrome is the clinical condition in which reproductive age females suffer from emotional and physical symptoms not related to any disease, starting usually five days before the menstrual cycle for three consecutive cycles. As menstrual cycle starts in females these symptoms vanish on 4th day of menstruation. Around 10% to 53% of female adults suffer from this condition. This condition limits activities of daily life and adversely effects the quality of life therefore, the administration of proper medical intervention is very important. Aerobic exercises and progressive muscle relaxation exercises have been effective in the treatment of premenstrual syndrome previously in a few studies. However, these two interventions have never been compared to test their effects on pain, and functional performance.
- Conditions
- Pain Syndrome, Anxiety
- Being tested
- Aerobic exercises, Progressive muscle relaxation
- Medical subject headings
- Somatoform Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercisesOther
To compare the effects of aerobic exercise and progressive muscle relaxation exercises on pain and quality of life in premenstrual syndrome
Progressive muscle relaxationOther
progressive muscle relaxation exercises.
| Study group | Role | What they receive |
|---|---|---|
| Group A: aerobic exercises. | Experimental | The first treatment group will be given aerobic exercises for six weeks at least three times per week. This group will include 14 participants. This study group will be assigned with basic treatment protocol with aerobic exercises along with 10 minutes of warm up period. Receives: Other: Aerobic exercises |
| group b progressive muscle relaxation exercises. | Active comparator | The intervention will be given three days per week for six weeks. Pre and post-treatment readings will be noted. Each total session will last for 45 minutes. The importance of the study will be explained, and consent will be taken from the people before the intervention will be applied.
* Breathe in, and tense the first muscle group (hard but not to the point of pain or cramping) for 4 to 10 seconds.
* Breathe out, and suddenly and completely relax the muscle group (do not relax it gradually) (20) Receives: Other: Progressive muscle relaxation |
| Group C. Control group | No intervention | No intervention was given |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. For Anxiety, Depression: • DASS-21 The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.(16)
Measured: 6 weeks
Numerical rating scales (NRSs)
Numerical rating scales (NRSs) are the simplest and most commonly used scale. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable
Measured: 6 weeks
• SF-36 The 36-Item Short Form Health Survey questionnaire (SF-36)
The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start2 Nov 2022
- Primary completion30 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatima Tariq, Mphill, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811455
- Sponsor's protocol ID
- REC/RCR & AHS/22/054
- Status last verified
- Mar 2023
- First submitted
- 31 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Aerobic Exercises and Progressive Muscle Relaxation Exercises on Pain,Anxiety and Quality of Life
- ClinicalTrials.gov ID
- NCT05811455
- Acronym / sponsor ID
- REC/RCR & AHS/22/054
- Conditions
- Pain Syndrome, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 13 Apr 2023 (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.
Premenstrual syndrome is the clinical condition in which reproductive age females suffer from emotional and physical symptoms not related to any disease, starting usually 5 days before the menstrual cycle for 3 consecutive cycles.
Detailed description
Premenstrual syndrome is the clinical condition in which reproductive age females suffer from emotional and physical symptoms not related to any disease, starting usually five days before the menstrual cycle for three consecutive cycles. As menstrual cycle starts in females these symptoms vanish on 4th day of menstruation. Around 10% to 53% of female adults suffer from this condition. This condition limits activities of daily life and adversely effects the quality of life therefore, the administration of proper medical intervention is very important. Aerobic exercises and progressive muscle relaxation exercises have been effective in the treatment of premenstrual syndrome previously in a few studies. However, these two interventions have never been compared to test their effects on pain, and functional performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: aerobic exercises. | Experimental | Other: Aerobic exercisesThe first treatment group will be given aerobic exercises for six weeks at least three times per week. This group will include 14 participants. This study group will be assigned with basic treatment protocol with aerobic exercises along with 10 minutes of warm up period. |
| group b progressive muscle relaxation exercises. | Active comparator | Other: Progressive muscle relaxationThe intervention will be given three days per week for six weeks. Pre and post-treatment readings will be noted. Each total session will last for 45 minutes. The importance of the study will be explained, and consent will be taken from the people before the intervention will be applied. * Breathe in, and tense the first muscle group (hard but not to the point of pain or cramping) for 4 to 10 seconds. * Breathe out, and suddenly and completely relax the muscle group (do not relax it gradually) (20) |
| Group C. Control group | No intervention | –No intervention was given |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 to 40 years
- Females in their last week of the luteal phase (1 week before menstruation)
- Females with regular menstrual with equal intervals between 21 and 35 days
- Females with a score of 133 and above after being screened with Premenstrual syndrome scale
- Females suffering from PMS for at least the past six months
Key exclusion criteria (5 listed)
- Females with the irregular menstrual cycle
- Pregnant females
- Menstruating females or females in the follicular or ovulatory phase
- History of physical exercise in the past three months before the beginning of the study
- Females suffering from other gynecological issues such as endometriosis, PCOS, uterine or cervical cancer
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 exercisesTo compare the effects of aerobic exercise and progressive muscle relaxation exercises on pain and quality of life in premenstrual syndrome | Other | Group A: aerobic exercises. |
| Progressive muscle relaxationprogressive muscle relaxation exercises. | Other | group b progressive muscle relaxation exercises. |
Primary outcome
1. For Anxiety, Depression: • DASS-21 The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
Time frame: 6 weeks
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.(16)
Numerical rating scales (NRSs)
Time frame: 6 weeks
Numerical rating scales (NRSs) are the simplest and most commonly used scale. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable
• SF-36 The 36-Item Short Form Health Survey questionnaire (SF-36)
Time frame: 6 weeks
The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH)
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 13 Apr 2023.
- 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.
Fatima Tariq, Mphill principal investigator
Riphah International 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 Aerobic exercises and Progressive muscle relaxation in people with Pain Syndrome and Anxiety, run by Riphah International University at 1 site in Pakistan.
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 5 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 13 Apr 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 Pakistan. 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?
1. For Anxiety, Depression: • DASS-21 The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) (time frame: 6 weeks). The study lists 3 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 13 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.