| CTRI Number |
CTRI/2020/03/023676 [Registered on: 02/03/2020] Trial Registered Prospectively |
| Last Modified On: |
28/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
EFFECT OF LAND EXERCISES VS WATER EXERCISES IN POSTNATAL FEMALES WITH UPPER BACK PAIN |
|
Scientific Title of Study
|
Effect of land based exercise v/s water based exercises in post partum women with upper back pain: A Randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DAMINI N HALDANKAR |
| Designation |
pg student |
| Affiliation |
KLEU INSTITUTE OF PHYSIOTHERAPY |
| Address |
KLEU INSTITUTE OF PHYSIOTHERAPY NEHRU NAGAR BELAGAVI KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
7021298195 |
| Fax |
|
| Email |
damini.haldankar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arati Mahishale |
| Designation |
professor |
| Affiliation |
KLEU INSTITUTE OF PHYSIOTHERAPY |
| Address |
KLEU INSTITUTE OF PHYSIOTHERAPY NEHRU NAGAR BELAGAVI KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
mphysioarati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DAMINI N HALDANKAR |
| Designation |
pg student |
| Affiliation |
KLEU INSTITUTE OF PHYSIOTHERAPY |
| Address |
KLEU INSTITUTE OF PHYSIOTHERAPY NEHRU NAGAR BELAGAVI KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
7021298195 |
| Fax |
|
| Email |
damini.haldankar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DAMINI N HALDANKAR |
| Address |
KLEU INSTITUTE OF PHYSIOTHERAPY NEHRU NAGAR BELAGAVI KARNATAKA |
| 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 |
| DAMINI N HALDANKAR |
DR PRABHAKAR KORE HOSPITAL |
OPD NO.39 ADVANCED PHYSICAL THERAPY DEPT.
Belgaum
KARNATAKA |
7021298195
damini.haldankar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH AND ETHICAL COMMITTEE KLEU INSTITUTE OF PHYSIOTHERAPY BELAGAVI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
POSTPARTUM FEMALES WITH UPPER BACK PAIN |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LAND EXERCISE
WATER EXERCISE |
AQUATIC BASED EXERCISE GROUP 2: F- 3 times / week for 3 weeks I- low to moderate intensity (monitored using Borgs rate of perceived exertion Scale) T- 40 mins with 20 mins warm up and cool down total sessions each T- aerobic exercise Warm up period-10 mins(including stretching of upper back muscles, alternate leg hopping, breathing) Aerobic training- 20 mins(including movements of upper limbs, movements of upper back ) Cool down period- 10 mins(relaxation in pool ,breathing ) EXERCISE Breathing exercises-10 repetitions Stretching of all set of muscles of neck and upper back-3 repetitions for 30s hold each Lateral trunk flexor stretch Scapular retraction Angel wings for shoulder range of motion Front and back chest press With 15 to 20 repetitions each |
| Comparator Agent |
LAND EXERCISE
WATER EXERCISE |
LAND BASED EXERCISE GROUP 1:
F- 3 times / week for 3 weeks
I- low to moderate intensity (monitored using Borgs rate of perceived exertion Scale)
T- 40 mins with 20 mins warm up and cool down total sessions each
T- aerobic exercise
Warm up period-10mins including breathing exercise , stretching of neck and upper back muscles , neck movements , upper extremity movements
Aerobic training-20mins
Cool down period-10mins including relaxation
EXERCISES
Breathing exercises-10 repetitions
Stretching of all sets of neck muscles and upper back muscles -3 repetition with 30 s hold each
Neck movements-15 to 20 repetitions
All set of upper extremity movements-15 to 20 repetitions
Scapulothoracic movements including scapula retraction, combined scapular retraction with shoulder lateral rotation ,shoulder press forward punch etc. for 15 to 20 repetitions
AQUATIC BASED EXERCISE GROUP 2:
F- 3 times / week for 3 weeks
I- low to moderate intensity (monitored using Borgs rate of perceived exertion Scale)
T- 40 mins with 20 mins warm up and cool down total sessions each
T- aerobic exercise
Warm up period-10 mins(including stretching of upper back muscles, alternate leg hopping, breathing)
Aerobic training- 20 mins(including movements of upper limbs, movements of upper back )
Cool down period- 10 mins(relaxation in pool ,breathing )
EXERCISE
Breathing exercises-10 repetitions
Stretching of all set of muscles of neck and upper back-3 repetitions for 30s hold each
Lateral trunk flexor stretch
Scapular retraction
Angel wings for shoulder range of motion
Front and back chest press
With 15 to 20 repetitions each
|
| Intervention |
LAND EXERCISE
WATER EXERCISE |
LAND BASED EXERCISE GROUP 1:
F- 3 times / week for 3 weeks
I- low to moderate intensity (monitored using Borgs rate of perceived exertion Scale)
T- 40 mins with 20 mins warm up and cool down total sessions each
T- aerobic exercise
Warm up period-10mins including breathing exercise , stretching of neck and upper back muscles , neck movements , upper extremity movements
Aerobic training-20mins
Cool down period-10mins including relaxation
EXERCISES
Breathing exercises-10 repetitions
Stretching of all sets of neck muscles and upper back muscles -3 repetition with 30 s hold each
Neck movements-15 to 20 repetitions
All set of upper extremity movements-15 to 20 repetitions
Scapulothoracic movements including scapula retraction, combined scapular retraction with shoulder lateral rotation ,shoulder press forward punch etc. for 15 to 20 repetitions
AQUATIC BASED EXERCISE GROUP 2:
F- 3 times / week for 3 weeks
I- low to moderate intensity (monitored using Borgs rate of perceived exertion Scale)
T- 40 mins with 20 mins warm up and cool down total sessions each
T- aerobic exercise
Warm up period-10 mins(including stretching of upper back muscles, alternate leg hopping, breathing)
Aerobic training- 20 mins(including movements of upper limbs, movements of upper back )
Cool down period- 10 mins(relaxation in pool ,breathing )
EXERCISE
Breathing exercises-10 repetitions
Stretching of all set of muscles of neck and upper back-3 repetitions for 30s hold each
Lateral trunk flexor stretch
Scapular retraction
Angel wings for shoulder range of motion
Front and back chest press
With 15 to 20 repetitions each
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Female subjects within the age group 21-35 years
History of upper back pain
Primiparous and multiparous
FTND and LSCS
Women who are breastfeeding
6 months to 1 year postpartum females
Subjects willing to participate
|
|
| ExclusionCriteria |
| Details |
Performing regular exercises of upper back
Females who have skin disease or skin infection
Open wounds
Females who are hydrophobic
Undergoing treatment for upper back and neck
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
BACK SCRATCH TEST
PLUMB LINE
FLEXICURVE
OSWESTRY DISABILITY INDEX |
PRE -0 WEEKS;POST-3 WEEKS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NONE |
PRE-0 WEEKS;POST-3 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
|
A study done
by Eric Watelain et al , in 2017
stated that exercise for trunk muscles reduces pain , improves quality of
life and physical health of females during pregnancy and 2 months postpartum.
Literature concluded that physical exercise helps to
reduce low back and pelvic girdle pain in pregnancy.
Many studies
have been done to determine the effects of aquatic therapy during pregnancy ,
but however there is derth of literature to determine the effects of aquatic
therapy in postpartum .Also there is a paucity of data to determine effect
land based exercise on upper back and its effects on pain flexibility and
posture.
Hence the
present study has been undertaken to compare the effect of land based and
aquatic exercise on upper back pain in postpartum females on flexibility and
posture.
|
Alternate
Hypothesis(Ha):Either land based
exercise or water based exercise will be more effective on pain , flexibility
and posture in postpartum women
Null
Hypothesis (H0):Land based exercise and
water based exercise will be equally effective or will not be equally
effective on pain , flexibility and posture in postpartum women
|
|
|