Effects of Progressive Resistance Training Vasomotor Symptoms in Post Menopausal Women

NCT06166264 | Unknown

• 1 other identifier: Saba Murtaza
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Menopausal

Keywords

Depression; Fatigue; Vasomotor symptoms; Post-menopause

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Progressive resistance training

EXPERIMENTAL

Other: Progressive resistance training

Control group

EXPERIMENTAL

Other: Control group

Interventions

Progressive resistance training OTHER

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.

Progressive resistance training

Control group OTHER

The participants will receive information regarding health education.

Control group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Chronic metabolic and endocrine diseases Receiving hormone replacement treatment Surgical menopause Cognitive impairment

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Civil Hospital Samundry

Samundry, Pakistan

RECRUITING

Related Publications (3)

• 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.

  PMID: 25431132 BACKGROUND

• 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.

  PMID: 9651903 BACKGROUND

• 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.

  PMID: 34240669 BACKGROUND

MeSH Terms

Conditions

Depression; Fatigue

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: April 5, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 10, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)