Psychological Well-BeingNCT06048939
Combined Effect of Aerobic and Resistance Training on Physical, Menstrual and Psychological Health of Adolescent Girls.
A study testing moderate intensity aerobic training and body weight resistance training and moderate intensity aerobic training in people with Psychological Well-Being, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study proposes to find out the Combined Effect of Aerobic \& Resistance Training on physical, menstrual and psychological health of Adolescent Girls. The study results will be helpful to explore the mode and intensity of aerobic and resistance exercise and for creating strategies for improving the lifestyle of… Read more about this study
- Who is it for?
- Ages 13 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psychological Well-Being
- What is being tested?
- moderate intensity aerobic training and body weight resistance training and moderate intensity aerobic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Jun 2023to 20 Jan 2024
- 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 13 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female adolescents who have achieved Menarche.
- 13-19 years of age
- BMI criteria: 17.50 - 22.99 (BMI Asia)
- Score less than 13 on IPAQ (Inactive)
Who cannot join
- History of musculoskeletal trauma or injury
- Any diagnosed psychological condition
- Participated in Exercise program for past 6 months
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Vega school system Dinga
Dinga, Punjab Province, 50280
Summra Andleeb, MS(0MPT), 03450617872, sammra.andleeb@riphah.edu.pk
Saira Shabeer, MS(WHPT)
About this study
Official title: Combined Effect of Aerobic and Resistance Training on Physical, Menstrual and Psychological Health of Adolescent Girls
This study proposes to find out the Combined Effect of Aerobic \& Resistance Training on physical, menstrual and psychological health of Adolescent Girls. The study results will be helpful to explore the mode and intensity of aerobic and resistance exercise and for creating strategies for improving the lifestyle of the adolescents by adopting the appropriate exercise guidelines.
Read the detailed description
Adolescence is a time of rapid growth and development as well as a crucial time for the formation of behaviors connected to one's health (1). This stage is characterized by simultaneous hormonal, psychological, and physical changes. Regular exercise is an essential part of an all-encompassing plan to protect against numerous risk factors Physical inactivity, sedentary behavior and low cardio respiratory fitness are strong risk factors for morbidity and mortality. There is emerging evidence to link increased time spent using screens for leisure, with poorer mental health experiences among adolescents. Research has shown that physical activity can play a vital role in improving both their physical and psychological well-being.
The evidence suggests that moderate aerobic exercise can have a positive impact on menstrual cycle regularity and reducing menstrual pain. Resistance training can increase the levels of various hormones and neurotransmitters like endorphins, dopamine, serotonin, and nor epinephrine in the brain that are attributed to improved mood and reduced feelings of anxiety.
Aerobic exercise is performed by repeating sequences of light-to-moderate intensity activities for extended periods of time. Exercises are typically done at 60-70% of heart rate, while resistance training, also known as strength training, uses external resistance to enhance muscle mass, strength, tone, balance, and mental well-being Previous studies show that engaging adolescents in resistance or combined training is essential to the maintenance and/or improving muscular fitness. Another study reported both HIIT and MICT appear to be similarly effective on risk factors of CVD. Incorporating diverse exercises in physical education classes for adolescent girls improves overall fitness, benefiting their long-term health and well-being. The 2017 study highlighted the importance of expert trainers, supervision, and customized weight training in resistance training for children and adolescents, leading to improved physical fitness. Regular physical activity can reduce leptin levels and relax abdominal muscles, leading to pain relief and enhanced quality of life. Ginger, aerobic exercise, and stretching exercises can alleviate physical symptoms and reduce pain intensity and duration in girls with dysmenorrhea by promoting blood flow and metabolism in the uterus. Regular aerobic exercise reduces negative mood states and physical symptoms in women during the menstrual cycle, consistent with previous studies.
Aerobic exercise alleviates dysmenorrhea symptoms by releasing natural painkillers and suppressing the release of pain-causing prostaglandins during menstruation. Aerobic exercise may help reduce menstrual pain by increasing blood flow to working muscles, potentially relieving congestion.
Evidence demonstrates that menstrual cycle irregularity, which is most frequently addressed in adolescence, is also linked to sedentary lifestyle, psychological stress, and aggressive physical activity. There is a tonne of data that aerobic and resistance training affects vascular function, obesity, and diabetes.
The lack of research on the effects of aerobic and resistance training on adolescent girls' physical fitness, mental health, and menstrual cycle underscores the importance of understanding how physical activity influences these variables. A study found that Resistance band training for 8 weeks improved mood, behavior, and physical menstrual symptoms in non-athletic teenage girls with premenstrual syndrome. A study found that participating in an 8-week aerobic exercise program significantly reduced dysmenorrhea severity in medical students compared to a control group, as observed in the first and second menstrual cycles after the intervention. A study conducted in 2022 by a medical student found that vigorous exercise during menstruation can lead to increased estrogen and progesterone levels, resulting in more menstrual pain due to increased blood flow.
Evidence shows irregularity in menstrual cycle addressed most commonly in adolescents is associated with sedentary life style and psychological stress. The idea that exercise might help to relieve menstrual pain is not new. Aerobic exercise is one of the exercise option whose significant effects were seen in dysmenorrhea and pre-menstural symptoms. Gap regarding relief in menstrual cycle symtopms with resistance exercises is need to be filled. Furthermore no such study was done to compare the effects of aerobic and resistance exercises on menstrual, physical and psychological health of adolescent girls at a time. Therefore current study proposes to find out the Combined Effect of Aerobic \& Resistance Training on these problems of Adolescent Girls. The study results will be helpful to explore the mode and intensity of resistance exercise and for creating strategies for improving the lifestyle of the adolescents by adopting the appropriate exercise guidelines.
- Conditions
- Psychological Well-Being
- Being tested
- moderate intensity aerobic training and body weight resistance training, moderate intensity aerobic training
- Keywords
- psychological well-being, Menstrual Problem, Physical inactivity
- Medical subject headings
- Psychological Well-Being, Menstruation Disturbances, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moderate intensity aerobic training and body weight resistance trainingOther
Bodyweight Resistance exercises Frequency: twice a week Intensity: moderate Time: 40 Minutes Warm up: 10mins Rotations and Dynamic stretches Body weight resistance Exercises: 20mins Calf raises (1 x 10-15 Reps) Squats (1 x 10-15 Reps) Lunges (1 x 10-15 Reps on each side) Modified push-ups (1 x 10-15 Reps) Bridging (1 x 10-15 Reps) Plank hold (10 Seconds) Side planks (10 Seconds each side) Cool down: 10 mins Slow marching and static stretches for next 6 weeks progression will be made by adding one more set of same exercises Aerobic training: Frequency: 2 Days per week Intensity: 60% of maximum heart rate. Time: 45 Minutes Exercise Protocol Warm up: 10mins Rotations and Dynamic stretches
Aerobic exercises will be same as given to control group
moderate intensity aerobic trainingOther
Aerobic Exercises Frequency: 2 Days per week Intensity: 60% of maximum heart rate. Time: 45 Minutes Warm up: 10mins Rotations and Dynamic stretches Aerobic exercises: 25 mins
(1 minute of each exercise with 60 seconds rest and repeating the same sequence for 1 minute.) Exercises will be performed at slow pace Marching, Single step touch, Step touches front and back, Double step touch, "V" step, knee lift, leg curl , forward walk, reach outs, lunge side and back, "L" Step, jumping jacks Cool down: 10 mins Slow marching and static stretches for next 6weeks progression will be made by increasing speed of same exercises
| Study group | Role | What they receive |
|---|---|---|
| aerobic and resistance training | Experimental | moderate intensity aerobic and body weight resistance training on female adolescents. Receives: Other: moderate intensity aerobic training and body weight resistance training |
| aerobic training | Active comparator | moderate intensity aerobic and body weight resistance training on female adolescents. Receives: Other: moderate intensity aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual Health Instrument (MHI)
The Menstrual Health Instrument (MHI) is a comprehensive 29-item scale that assesses the physical and emotional well-being of adolescents regarding menstruation. It covers five sub-scales and utilizes a 5-point Likert scale (from strongly disagree to strongly agree)
Measured: at 1st week and after 12th week
Secondary outcomes (1)
The Alpha Health Related Fitness Test Battery for Children And Adolescents
The Alpha Health Related Fitness Test Battery has been shown to have good validity in assessing health-related fitness components in children and adolescents. The results consistently demonstrate significant correlations, indicating that the test battery accurately measures these fitness components.
Measured: at 1st week and after 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start22 Jun 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion20 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological Well-BeingStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- summra andleeb, MS(OMPT), Principal investigator, riphah internation university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048939
- Sponsor's protocol ID
- REC/01543 Saira Shabbir
- Status last verified
- Sep 2023
- First submitted
- 23 Jul 2023
- Last updated
- 21 Sep 2023
- 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 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Aerobic and Resistance Training on Physical, Menstrual and Psychological Health of Adolescent Girls
- ClinicalTrials.gov ID
- NCT06048939
- Acronym / sponsor ID
- REC/01543 Saira Shabbir
- Conditions
- Psychological Well-Being
- Keywords
- psychological well-being, Menstrual Problem, Physical inactivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 20 Jan 2024 (estimated)
- First posted
- 21 Sep 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.
This study proposes to find out the Combined Effect of Aerobic \& Resistance Training on physical, menstrual and psychological health of Adolescent Girls. The study results will be helpful to explore the mode and intensity of aerobic and resistance exercise and for creating strategies for improving the lifestyle of the adolescents by adopting the appropriate exercise guidelines.
Detailed description
Adolescence is a time of rapid growth and development as well as a crucial time for the formation of behaviors connected to one's health (1). This stage is characterized by simultaneous hormonal, psychological, and physical changes. Regular exercise is an essential part of an all-encompassing plan to protect against numerous risk factors Physical inactivity, sedentary behavior and low cardio respiratory fitness are strong risk factors for morbidity and mortality. There is emerging evidence to link increased time spent using screens for leisure, with poorer mental health experiences among adolescents. Research has shown that physical activity can play a vital role in improving both their physical and psychological well-being.
The evidence suggests that moderate aerobic exercise can have a positive impact on menstrual cycle regularity and reducing menstrual pain. Resistance training can increase the levels of various hormones and neurotransmitters like endorphins, dopamine, serotonin, and nor epinephrine in the brain that are attributed to improved mood and reduced feelings of anxiety.
Aerobic exercise is performed by repeating sequences of light-to-moderate intensity activities for extended periods of time. Exercises are typically done at 60-70% of heart rate, while resistance training, also known as strength training, uses external resistance to enhance muscle mass, strength, tone, balance, and mental well-being Previous studies show that engaging adolescents in resistance or combined training is essential to the maintenance and/or improving muscular fitness. Another study reported both HIIT and MICT appear to be similarly effective on risk factors of CVD. Incorporating diverse exercises in physical education classes for adolescent girls improves overall fitness, benefiting their long-term health and well-being. The 2017 study highlighted the importance of expert trainers, supervision, and customized weight training in resistance training for children and adolescents, leading to improved physical fitness. Regular physical activity can reduce leptin levels and relax abdominal muscles, leading to pain relief and enhanced quality of life. Ginger, aerobic exercise, and stretching exercises can alleviate physical symptoms and reduce pain intensity and duration in girls with dysmenorrhea by promoting blood flow and metabolism in the uterus. Regular aerobic exercise reduces negative mood states and physical symptoms in women during the menstrual cycle, consistent with previous studies.
Aerobic exercise alleviates dysmenorrhea symptoms by releasing natural painkillers and suppressing the release of pain-causing prostaglandins during menstruation. Aerobic exercise may help reduce menstrual pain by increasing blood flow to working muscles, potentially relieving congestion.
Evidence demonstrates that menstrual cycle irregularity, which is most frequently addressed in adolescence, is also linked to sedentary lifestyle, psychological stress, and aggressive physical activity. There is a tonne of data that aerobic and resistance training affects vascular function, obesity, and diabetes.
The lack of research on the effects of aerobic and resistance training on adolescent girls' physical fitness, mental health, and menstrual cycle underscores the importance of understanding how physical activity influences these variables. A study found that Resistance band training for 8 weeks improved mood, behavior, and physical menstrual symptoms in non-athletic teenage girls with premenstrual syndrome. A study found that participating in an 8-week aerobic exercise program significantly reduced dysmenorrhea severity in medical students compared to a control group, as observed in the first and second menstrual cycles after the intervention. A study conducted in 2022 by a medical student found that vigorous exercise during menstruation can lead to increased estrogen and progesterone levels, resulting in more menstrual pain due to increased blood flow.
Evidence shows irregularity in menstrual cycle addressed most commonly in adolescents is associated with sedentary life style and psychological stress. The idea that exercise might help to relieve menstrual pain is not new. Aerobic exercise is one of the exercise option whose significant effects were seen in dysmenorrhea and pre-menstural symptoms. Gap regarding relief in menstrual cycle symtopms with resistance exercises is need to be filled. Furthermore no such study was done to compare the effects of aerobic and resistance exercises on menstrual, physical and psychological health of adolescent girls at a time. Therefore current study proposes to find out the Combined Effect of Aerobic \& Resistance Training on these problems of Adolescent Girls. The study results will be helpful to explore the mode and intensity of resistance exercise and for creating strategies for improving the lifestyle of the adolescents by adopting the appropriate exercise guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aerobic and resistance training | Experimental | Other: moderate intensity aerobic training and body weight resistance trainingmoderate intensity aerobic and body weight resistance training on female adolescents. |
| aerobic training | Active comparator | Other: moderate intensity aerobic trainingmoderate intensity aerobic and body weight resistance training on female adolescents. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Female adolescents who have achieved Menarche.
- 13-19 years of age
- BMI criteria: 17.50 - 22.99 (BMI Asia)
- Score less than 13 on IPAQ (Inactive)
Key exclusion criteria (3 listed)
- History of musculoskeletal trauma or injury
- Any diagnosed psychological condition
- Participated in Exercise program for past 6 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 |
|---|---|---|
| moderate intensity aerobic training and body weight resistance trainingBodyweight Resistance exercises Frequency: twice a week Intensity: moderate Time: 40 Minutes Warm up: 10mins Rotations and Dynamic stretches Body weight resistance Exercises: 20mins Calf raises (1 x 10-15 Reps) Squats (1 x 10-15 Reps) Lunges (1 x 10-15 Reps on each side) Modified push-ups (1 x 10-15 Reps) Bridging (1 x 10-15 Reps) Plank hold (10 Seconds) Side planks (10 Seconds each side) Cool down: 10 mins Slow marching and static stretches for next 6 weeks progression will be made by adding one more set of same exercises Aerobic training: Frequency: 2 Days per week Intensity: 60% of maximum heart rate. Time: 45 Minutes Exercise Protocol Warm up: 10mins Rotations and Dynamic stretches Aerobic exercises will be same as given to control group | Other | aerobic and resistance training |
| moderate intensity aerobic trainingAerobic Exercises Frequency: 2 Days per week Intensity: 60% of maximum heart rate. Time: 45 Minutes Warm up: 10mins Rotations and Dynamic stretches Aerobic exercises: 25 mins (1 minute of each exercise with 60 seconds rest and repeating the same sequence for 1 minute.) Exercises will be performed at slow pace Marching, Single step touch, Step touches front and back, Double step touch, "V" step, knee lift, leg curl , forward walk, reach outs, lunge side and back, "L" Step, jumping jacks Cool down: 10 mins Slow marching and static stretches for next 6weeks progression will be made by increasing speed of same exercises | Other | aerobic training |
Primary outcome
Menstrual Health Instrument (MHI)
Time frame: at 1st week and after 12th week
The Menstrual Health Instrument (MHI) is a comprehensive 29-item scale that assesses the physical and emotional well-being of adolescents regarding menstruation. It covers five sub-scales and utilizes a 5-point Likert scale (from strongly disagree to strongly agree)
1 secondary outcome
The Alpha Health Related Fitness Test Battery for Children And Adolescents
Time frame: at 1st week and after 12th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 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.
summra andleeb, MS(OMPT) principal investigator
riphah internation 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 moderate intensity aerobic training and body weight resistance training and moderate intensity aerobic training in people with Psychological Well-Being, 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual Health Instrument (MHI) (time frame: at 1st week and after 12th week). 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 21 Sep 2023.