Effects of Progressive Resistance Training Vasomotor Symptoms in Post Menopausal Women

Post Menopausal Clinical Trial

Official title:

Effects of Progressive Resistance Training on Depression , Fatigue and Vasomotor Symptoms in Post Menopausal Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06166264
• Other study ID #: Saba Murtaza
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2023
• Est. completion date: January 10, 2024

Study information

• Verified date: December 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: January 10, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 60 Years

Eligibility

Inclusion Criteria:

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. Exclusion Criteria: Chronic metabolic and endocrine diseases Receiving hormone replacement treatment Surgical menopause Cognitive impairment

Related Conditions & MeSH terms

• Post Menopausal

Intervention

Other:
• Progressive resistance training
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 group
The participants will receive information regarding health education.

Locations

Country	Name	City	State
Pakistan	Civil Hospital Samundry	Samundry

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Berin 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. — View Citation

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. — View Citation

Ivarsson 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6th week
Primary	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.	6th week
Primary	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.	6th Week