Clinical trial NCT06166264: Effects of Progressive Resistance Training Vasomotor Symptoms in Post Menopausal Women
Official title: Effects of Progressive Resistance Training on Depression , Fatigue and Vasomotor Symptoms in Post Menopausal Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Menopausal
Keywords: Depression
Fatigue
Vasomotor symptoms
Post-menopause
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 64
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hot Flash related Interference Scale (HFRDIS) for vasomotor symptoms
timeFrame: 6th week
measure: FATIGUE SEVERITY SCALE
timeFrame: 6th week
measure: DASS-21( Depression, Anxiety and stress scale 21-item
timeFrame: 6th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Samundry
country: Pakistan
facility: Civil Hospital Samundry
Study officials:
References:
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.
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.
citation: 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.