Post MenopausalNCT06166264
Effects of Progressive Resistance Training Vasomotor Symptoms in Post Menopausal Women
A study testing Progressive resistance training in people with Post Menopausal, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study will be a randomized clinical trial and will be conducted in Civil Hospital and Kalsoom Hospital Samundry. This study will be completed in time duration of 10 months after the approval of synopsis. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Menopausal
- What is being tested?
- Progressive resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Apr 2023to 10 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 50 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Post-menopausal women with age 50 - 60 years Blood pressure less than 160 / 100 More than or equal to 4 moderate-severe vasomotor symptoms including hot flushes, nocturnal sweats, sweating and poor sleep.
Who cannot join
- Chronic metabolic and endocrine diseases Receiving hormone replacement treatment Surgical menopause Cognitive impairment
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Civil Hospital Samundry
Samundry
Adeela Arif, Mphil, 03320845723, adeela.arif@riphah.edu.pk
About this study
Official title: Effects of Progressive Resistance Training on Depression , Fatigue and Vasomotor Symptoms in Post Menopausal Women
The study will be a randomized clinical trial and will be conducted in Civil Hospital and Kalsoom Hospital Samundry. This study will be completed in time duration of 10 months after the approval of synopsis. Non probability convenience sampling with Randomization technique will be used and 26 participants will be recruited in study after randomization. The subjects will be divided into two groups and the group A will receive Progressive training and Health education and group B will receive only Health education. The data will be assessed at the baseline and after 8th week of treatment. After data collection data will be analyzed by using SPSS version 21.
Read the detailed description
The significance of this study is that it may improve the postmenopausal symptoms like depression and vasomotor symptoms which includes hot flushes , night sweats etc .in postmenopausal females. The majority of studies examining the vasomotor symptoms affected by symptoms of post menopause have concentrated on the effects of therapies like hormone therapy.To our knowledge, no studies have looked at the connection between vasomotor symptoms,depression and resistance training. Without doing so, it is challenging to understand how Vasomotor symptoms have an impact. This study sought to fill in the knowledge vaccum by examining the resistance training effect on depression , fatigue and vasomotor symptoms.
- Conditions
- Post Menopausal
- Being tested
- Progressive resistance training, Control group
- Keywords
- Depression, Fatigue, Vasomotor symptoms, Post-menopause
- Medical subject headings
- Depression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive resistance trainingOther
It consists of patients who will receive both Resistance exercise training sessions and aerobic training 3 times per week for 8 weeks. Every session will be of 45 minutes. Exercises used in the resistance exercise 1)Standing chess press;(2)Strengthening back muscles in sitting position;(3)Standing strengthening abduction of both shoulders;(4)Standing strengthening flexion of both shoulders;(5)Standing strengthening flexion of both forearms;(6)Standing strengthening extension of both forearms;(7)Strengthening extension of both knees in sitting position;(8)Strengthening flexion of both knees in sitting position;(9)Strengthening dorsiflexion of both ankles in sitting position.
Control groupOther
The participants will receive information regarding health education.
| Study group | Role | What they receive |
|---|---|---|
| Progressive resistance training | Experimental | Not described Receives: Other: Progressive resistance training |
| Control group | Experimental | Not described Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hot Flash related Interference Scale (HFRDIS) for vasomotor symptoms
The HFRDIS is a 10-item scale which measures the degree hot flashes interfere with daily activities; the tenth item measures the degree hot flashes interfere with overall quality of life. The HFRDIS was internally consistent, with alphas of 0.96 at times
Measured: 6th week
FATIGUE SEVERITY SCALE
The Fatigue Severity Scale (FSS) is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle.
Measured: 6th week
DASS-21( Depression, Anxiety and stress scale 21-item
DASS-21 is a self reported questionnaire which is used to assess the severity of range of symptoms like depression, anxiety and stress. It is not only used to measure the severity of symptoms but can also be used to assess the subject's response to treatment.The reliability of DASS-21 showed that it has excellent Cronbach's alpha values of 0.81,0.89 and 0.78 for the subscales of depressive, anxiety and stress respectively.
Measured: 6th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start5 Apr 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion10 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post MenopausalStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adeela Arif, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166264
- Sponsor's protocol ID
- Saba Murtaza
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Daley A, Stokes-Lampard H, Thomas A, MacArthur C. Exercise for vasomotor menopausal symptoms. Cochrane Database Syst Rev. 2014 Nov 28;2014(11):CD006108. doi: 10.1002/14651858.CD006108.pub4.
PubMed 25431132Ivarsson T, Spetz AC, Hammar M. Physical exercise and vasomotor symptoms in postmenopausal women. Maturitas. 1998 Jun 3;29(2):139-46. doi: 10.1016/s0378-5122(98)00004-8.
PubMed 9651903Berin E, Hammar M, Lindblom H, Lindh-Astrand L, Spetz Holm AC. Effects of resistance training on quality of life in postmenopausal women with vasomotor symptoms. Climacteric. 2022 Jun;25(3):264-270. doi: 10.1080/13697137.2021.1941849. Epub 2021 Jul 9.
PubMed 34240669
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progressive Resistance Training on Depression , Fatigue and Vasomotor Symptoms in Post Menopausal Women
- ClinicalTrials.gov ID
- NCT06166264
- Acronym / sponsor ID
- Saba Murtaza
- Conditions
- Post Menopausal
- Keywords
- Depression, Fatigue, Vasomotor symptoms, Post-menopause
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 10 Jan 2024 (estimated)
- First posted
- 12 Dec 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.
The study will be a randomized clinical trial and will be conducted in Civil Hospital and Kalsoom Hospital Samundry. This study will be completed in time duration of 10 months after the approval of synopsis. Non probability convenience sampling with Randomization technique will be used and 26 participants will be recruited in study after randomization. The subjects will be divided into two groups and the group A will receive Progressive training and Health education and group B will receive only Health education. The data will be assessed at the baseline and after 8th week of treatment. After data collection data will be analyzed by using SPSS version 21.
Detailed description
The significance of this study is that it may improve the postmenopausal symptoms like depression and vasomotor symptoms which includes hot flushes , night sweats etc .in postmenopausal females. The majority of studies examining the vasomotor symptoms affected by symptoms of post menopause have concentrated on the effects of therapies like hormone therapy.To our knowledge, no studies have looked at the connection between vasomotor symptoms,depression and resistance training. Without doing so, it is challenging to understand how Vasomotor symptoms have an impact. This study sought to fill in the knowledge vaccum by examining the resistance training effect on depression , fatigue and vasomotor symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive resistance training | Experimental | Other: Progressive resistance training |
| Control group | Experimental | Other: Control group |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Post-menopausal women with age 50 - 60 years Blood pressure less than 160 / 100 More than or equal to 4 moderate-severe vasomotor symptoms including hot flushes, nocturnal sweats, sweating and poor sleep.
Key exclusion criteria (1 listed)
- Chronic metabolic and endocrine diseases Receiving hormone replacement treatment Surgical menopause Cognitive impairment
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 |
|---|---|---|
| Progressive resistance trainingIt consists of patients who will receive both Resistance exercise training sessions and aerobic training 3 times per week for 8 weeks. Every session will be of 45 minutes. Exercises used in the resistance exercise 1)Standing chess press;(2)Strengthening back muscles in sitting position;(3)Standing strengthening abduction of both shoulders;(4)Standing strengthening flexion of both shoulders;(5)Standing strengthening flexion of both forearms;(6)Standing strengthening extension of both forearms;(7)Strengthening extension of both knees in sitting position;(8)Strengthening flexion of both knees in sitting position;(9)Strengthening dorsiflexion of both ankles in sitting position. | Other | Progressive resistance training |
| Control groupThe participants will receive information regarding health education. | Other | Control group |
Primary outcome
Hot Flash related Interference Scale (HFRDIS) for vasomotor symptoms
Time frame: 6th week
The HFRDIS is a 10-item scale which measures the degree hot flashes interfere with daily activities; the tenth item measures the degree hot flashes interfere with overall quality of life. The HFRDIS was internally consistent, with alphas of 0.96 at times
FATIGUE SEVERITY SCALE
Time frame: 6th week
The Fatigue Severity Scale (FSS) is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle.
DASS-21( Depression, Anxiety and stress scale 21-item
Time frame: 6th Week
DASS-21 is a self reported questionnaire which is used to assess the severity of range of symptoms like depression, anxiety and stress. It is not only used to measure the severity of symptoms but can also be used to assess the subject's response to treatment.The reliability of DASS-21 showed that it has excellent Cronbach's alpha values of 0.81,0.89 and 0.78 for the subscales of depressive, anxiety and stress respectively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Background: PubMed 25431132Daley A, Stokes-Lampard H, Thomas A, MacArthur C. Exercise for vasomotor menopausal symptoms. Cochrane Database Syst Rev. 2014 Nov 28;2014(11):CD006108. doi: 10.1002/14651858.CD006108.pub4.
- Background: PubMed 9651903Ivarsson T, Spetz AC, Hammar M. Physical exercise and vasomotor symptoms in postmenopausal women. Maturitas. 1998 Jun 3;29(2):139-46. doi: 10.1016/s0378-5122(98)00004-8.
- Background: PubMed 34240669Berin E, Hammar M, Lindblom H, Lindh-Astrand L, Spetz Holm AC. Effects of resistance training on quality of life in postmenopausal women with vasomotor symptoms. Climacteric. 2022 Jun;25(3):264-270. doi: 10.1080/13697137.2021.1941849. Epub 2021 Jul 9.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive resistance training in people with Post Menopausal, 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 1 inclusion and 1 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 12 Dec 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hot Flash related Interference Scale (HFRDIS) for vasomotor symptoms (time frame: 6th week). 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?
On the ClinicalTrials.gov record for NCT06166264, which also lists 3 linked publications.
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 12 Dec 2023.