| CTRI Number |
CTRI/2024/01/062074 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
13/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Dance therapy on quality of life & physical fitness in postmenopausal women |
|
Scientific Title of Study
|
Effectiveness of dance therapy on quality of life & physical fitness in postmenopausal women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Zarana Khamar PT |
| Designation |
Assistant Professor |
| Affiliation |
Venus Institute of Physiotherapy |
| Address |
Department of Physiotherapy Arush Physiotherapy College, near ghevar circle, shahibaug, Ahmedabad
A 401 Aditya Icon
Nava Vadaj
Ahmadabad
GUJARAT
380004
India |
| Phone |
9737763353 |
| Fax |
|
| Email |
zarana20057@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arvind Chauhan PT |
| Designation |
Principal |
| Affiliation |
Venus Institute of Physiotherapy |
| Address |
Venus Institute of Physiotherapy,At Bhoyan Rathod, opposite IFFCO,Near ONGC(WSS) Agalaj-Sertha Road, Gandhinagar,
Gandhinagar
GUJARAT
382420
India |
| Phone |
9913529221 |
| Fax |
|
| Email |
drarvindmpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arvind Chauhan PT |
| Designation |
Principal |
| Affiliation |
Venus Institute of Physiotherapy |
| Address |
Venus Institute of Physiotherapy,At Bhoyan Rathod, opposite IFFCO,Near ONGC(WSS) Agalaj-Sertha Road, Gandhinagar,
Gandhinagar
GUJARAT
382420
India |
| Phone |
9913529221 |
| Fax |
|
| Email |
drarvindmpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Arush Physiotherapy clinic
Near Mirapark Sahibaug Ahmedabad |
|
|
Primary Sponsor
|
| Name |
Dr Zarana Khamar |
| Address |
A 401 Aditya Icon, Behind Mirchi Ground Nava Vadaj Ahmedabad- 380013 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neelam Rathod |
Arush Physiotherapy Clinic |
Department of physiotherapy Arush Physiotherapy College
Near Ghevar Circle
Sahibaug 380004
Ahmadabad
GUJARAT |
9426948310
neelam_rathod128@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics commmittee, Venus institute of physiotherapy |
Approved |
| Institutional ethics commmittee, Venus institute of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postmenopausal women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aerobic Cycling |
3 times/ week for 4 weeks
Warm up
Aerobics cycling
Cool down
total duration-4 weeks |
| Intervention |
Dance Therapy |
3 times/week for 4 weeks
Increasing duration and intensity of aerobic dance therapy
in 1st and 2nd week low intensity dance therapy and 10 to 15 minutes duration
In 3rd and 4th week moderate to high intensity dance therapy and 20 to 25 minutes duration
warm up
dance therapy
cool down
total duration 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1)willing to participate
2)postmenopausal women(amenorrhea more than 1 year)
3) who can read and understand english language |
|
| ExclusionCriteria |
| Details |
1)Patients with Hysterectomy
2)Musculoskeletal Problems
3)Women on HRT
4)Illiterate or lack of understanding of english language
5)who exercise regularly
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Menopause specific quality of life questionnaire |
At the baseline and 4th week after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Senior fitness test |
1 year |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "46"
Final Enrollment numbers achieved (India)="46" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| Date of Study Completion (India) |
16/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Does quality of life affect postmenopausal women?
Menopausal Characteristics In Working Women & Its Correlation With Musculoskeletal Pain
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The Menopause is the permanent cessation of the menstrual cycle, with no menses for at least 12 months. In other words, it is called as natural termination of the menstrual phase of female life. The average age for the menopause is 46 years in Indian women. Menopause further divides into Perimenopause, Premenopause and Post menopause.The term Postmenopause is defined as dating from the final menstrual period, regardless of whether the menopause was induced or spontaneous.A significant negative relation between menopausal symptoms and quality of life (QoL) in middle-aged women has been observed in several national and multinational studies.Dance therapy has been deemed effective in the treatment of people with developmental, medical, social, physical, and psychological impairments.The Menopause Specific Quality of Life Questionnaire (MENQOL), was developed on women 47–62 years of age, is a valid, reliable, and responsive self-administered quality of life questionnaire specific to the early post-menopausal period. Rikli and Jones developed the Senior Fitness Test for adults aged over 60 years.1–4 It is primarily used to evaluate physical function in healthy elderly people but is also used for people with dementia. 5 It comprises six functional tests of strength, endurance, balance, agility and flexibility.Thus, aim of the study is to evaluate effectiveness of dance therapy on quality of life & Physical fitness in postmenopausal women.
|