Aging WellNCT06224465
Effect of Anti-aging Therapy on Fitness Enhancement in Perimenopausal Women
A study testing aerobic exercises in people with Aging Well, run by Cairo University at 1 site in Egypt.
Trial summary
Aging is an important fact to consider from the woman's health perspective. One of the most significant stages of aging is menopause, in which involves physical, psychological, and social changes in life Read more about this study
- Who is it for?
- Ages 40 to 50 years, women only
- Conditions the study is for
- Aging Well
- What is being tested?
- aerobic exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2024to 31 Jul 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 40 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- They complaining from fatigue, hot flushes and irregular period.
- Their Body Mass Index (BMI) between 25 to 30 .
- Their age ranged from 40 to 50 years old.
- The assessment procedures will be conducted on the same time of the day pre/post treatment.
Who cannot join
- Women with comorbidities such as cardiac disease and chest diseases as pulmonary fibrosis.
- Women received medications that might affect the neuromuscular functions at least three months before or during the study course.
- Women suffered from mental or psychological disorders.
- Women suffered from inflammatory diseases such as rheumatoid arthritis or polymyalgia rheumatic.
- Women complaining from osteoporosis.
Trial locations and contacts
1 site in 1 country.
About this study
Aging is an important fact to consider from the woman's health perspective. One of the most significant stages of aging is menopause, in which involves physical, psychological, and social changes in life
Read the detailed description
This study will be carried on forty perimenopausal women. They were selected randomly from outpatient clinic of El Kaser El-Einy University Hospital, Cairo University, their age ranged from 40 to 50 years.
Group A ( Control group):
It consisted of 20 perimenopausal women. They received anti-aging diet instructions.
Group B ( Experimental group):
It will be consisted of 20 perimenopausal women.They received anti-aging therapy (Aerobic, Flexibility and strengthening exercises) with anti aging diet instructions.
Randomization:
Randomization of sample selection was achieved using closed envelop way. Classification of the sample by simple random way into two groups equal in number, twenty for each group by using forty closed envelop, each twenty envelop contained a name of a group from the two groups (Group A) or (Group B) and asking each woman to choose one envelop from them, each woman attended to the group according the name of the group written in her envelop.
- Conditions
- Aging Well
- Being tested
- aerobic exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercisesOther
Also called flexibility exercises, strengthening exercises, anti aging diet instruction
Antiaging diet instruction :Be aware of the amount of calories, Reduce overall fat and sugar intake, Drink at least 10 glasses of water every day in order to remain healthy.
- Eat a variety of complex carbohydrates and vegetables instead of bread, rice, and corn.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Antiaging diet instructions Receives: Other: aerobic exercises |
| intervention group | Experimental | 1. aerobic exercises: walking :30 min on treadmill 30min at least three times per week for 12 weeks
2. Muscle strength Exercises:
For upper extremity : hand grip exercise, arm flexion exercise ten repetition for each exercise three times per week.
Theraband exercises for upper limb exercise ten repetition for each exercise three times per week.
3. Flexibility Exercise :
Curl up exercise and Seat and reach up exercises exercise ten repetition for each exercise three times per week.
Lateral flexibility exercises for ten repetition for each exercise three times per week,for 12 weeks and anti aging diet instruction Receives: Other: aerobic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walking test
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: 12 weeks
toe touch test
This test measures the flexibility of the lower back and hamstrings, and is a valid measure of this.The toe touch test is a common test of flexibility, and is an easy and quick test to perform. If using the standard testing procedure, there is a lot of published data to use for comparison.
Measured: 12 weeks
hand held dynamometer
Hand held dynamometer demonstrated an excellent intra- and inter-rater reliability for assessment of isometric lumbar muscles strength of healthy subject at clinical setting as it is simple to use, portable and cost-effective for the precise measurement.
Measured: 12 weeks
body composition analysis
Body composition is a method of describing what the body is made of. It includes fat, protein, minerals and body water. It also describes weight more accurately than BMI. Body composition analysis can accurately show changes in fat mass, muscle mass, and body fat percentage. This can help validate services
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start20 Jan 2024
- Primary completion20 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging WellStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- intervention: aerobic exercises: walking :30 min on treadmill 30min at least three times per week for 12 weeks 2)Muscle strength Exercises: For upper extremity : hand grip exercise, arm flexion exercise ten repetition for each exercise three times per week. Theraband exercises for upper limb exercise ten repetition for each exercise three times per week. 3\) Flexibility Exercise : Curl up exercise and Seat and reach up exercises exercise ten repetition for each exercise three times per week. Lateral flexibility exercises for ten repetition for each exercise three times per week,for 12 weeks
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzy Samih Nazmy, Cairo University
- Investigators
- Amel Yousef, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224465
- Sponsor's protocol ID
- P.T.REC/012/005035
- Status last verified
- Oct 2024
- First submitted
- 16 Jan 2024
- Last updated
- 9 Oct 2024
- 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 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anti-aging Therapy on Fitness Enhancement in Perimenopausal Women
- ClinicalTrials.gov ID
- NCT06224465
- Acronym / sponsor ID
- P.T.REC/012/005035
- Conditions
- Aging Well
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 25 Jan 2024 (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.
Aging is an important fact to consider from the woman's health perspective. One of the most significant stages of aging is menopause, in which involves physical, psychological, and social changes in life
Detailed description
This study will be carried on forty perimenopausal women. They were selected randomly from outpatient clinic of El Kaser El-Einy University Hospital, Cairo University, their age ranged from 40 to 50 years.
Group A ( Control group):
It consisted of 20 perimenopausal women. They received anti-aging diet instructions.
Group B ( Experimental group):
It will be consisted of 20 perimenopausal women.They received anti-aging therapy (Aerobic, Flexibility and strengthening exercises) with anti aging diet instructions.
Randomization:
Randomization of sample selection was achieved using closed envelop way. Classification of the sample by simple random way into two groups equal in number, twenty for each group by using forty closed envelop, each twenty envelop contained a name of a group from the two groups (Group A) or (Group B) and asking each woman to choose one envelop from them, each woman attended to the group according the name of the group written in her envelop.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- intervention: aerobic exercises: walking :30 min on treadmill 30min at least three times per week for 12 weeks 2)Muscle strength Exercises: For upper extremity : hand grip exercise, arm flexion exercise ten repetition for each exercise three times per week. Theraband exercises for upper limb exercise ten repetition for each exercise three times per week. 3) Flexibility Exercise : Curl up exercise and Seat and reach up exercises exercise ten repetition for each exercise three times per week. Lateral flexibility exercises for ten repetition for each exercise three times per week,for 12 weeks
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Other: aerobic exercisesAntiaging diet instructions |
| intervention group | Experimental | Other: aerobic exercises1. aerobic exercises: walking :30 min on treadmill 30min at least three times per week for 12 weeks 2. Muscle strength Exercises: For upper extremity : hand grip exercise, arm flexion exercise ten repetition for each exercise three times per week. Theraband exercises for upper limb exercise ten repetition for each exercise three times per week. 3. Flexibility Exercise : Curl up exercise and Seat and reach up exercises exercise ten repetition for each exercise three times per week. Lateral flexibility exercises for ten repetition for each exercise three times per week,for 12 weeks and anti aging diet instruction |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- They complaining from fatigue, hot flushes and irregular period.
- Their Body Mass Index (BMI) between 25 to 30 .
- Their age ranged from 40 to 50 years old.
- The assessment procedures will be conducted on the same time of the day pre/post treatment.
Key exclusion criteria (5 listed)
- Women with comorbidities such as cardiac disease and chest diseases as pulmonary fibrosis.
- Women received medications that might affect the neuromuscular functions at least three months before or during the study course.
- Women suffered from mental or psychological disorders.
- Women suffered from inflammatory diseases such as rheumatoid arthritis or polymyalgia rheumatic.
- Women complaining from osteoporosis.
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 exercisesAlso: flexibility exercises, strengthening exercises, anti aging diet instructionAntiaging diet instruction :Be aware of the amount of calories, Reduce overall fat and sugar intake, Drink at least 10 glasses of water every day in order to remain healthy. d. Eat a variety of complex carbohydrates and vegetables instead of bread, rice, and corn. | Other | control group, intervention group |
Primary outcome
6-minute walking test
Time frame: 12 weeks
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
toe touch test
Time frame: 12 weeks
This test measures the flexibility of the lower back and hamstrings, and is a valid measure of this.The toe touch test is a common test of flexibility, and is an easy and quick test to perform. If using the standard testing procedure, there is a lot of published data to use for comparison.
hand held dynamometer
Time frame: 12 weeks
Hand held dynamometer demonstrated an excellent intra- and inter-rater reliability for assessment of isometric lumbar muscles strength of healthy subject at clinical setting as it is simple to use, portable and cost-effective for the precise measurement.
body composition analysis
Time frame: 12 weeks
Body composition is a method of describing what the body is made of. It includes fat, protein, minerals and body water. It also describes weight more accurately than BMI. Body composition analysis can accurately show changes in fat mass, muscle mass, and body fat percentage. This can help validate services
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 9 Oct 2024.
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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.
Amel Yousef study chair
Cairo 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 in people with Aging Well, run by Cairo University at 1 site in Egypt.
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 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 9 Oct 2024. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
6-minute walking test (time frame: 12 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 9 Oct 2024.