| CTRI Number |
CTRI/2021/03/032360 [Registered on: 26/03/2021] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluation of hydrotherapy versus land-based exercise on rheumatoid arthritis. |
|
Scientific Title of Study
|
"Hydrotherapy versus-land based exercises on pain and quality of life (Qol)among patient with rheumatoid arthritis" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajendra Kumar jinjwaria |
| Designation |
student |
| Affiliation |
King george medical university lucknow |
| Address |
Room no 607, 6th floor kalam(Modern teaching block) centre KGMU Lucknow UP.
Room no 607, 6th floor kalam(Modern teaching block) centre KGMU Lucknow UP.
Lucknow
UTTAR PRADESH
226020
India |
| Phone |
08871206912 |
| Fax |
522-2257539 |
| Email |
rajendra4137@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Rashmi P John |
| Designation |
Assistant Professor |
| Affiliation |
King george medical university lucknow |
| Address |
Department of KGMU College of Nursing K.G.s Medical University U.P.Lucknow.
HOD Medical Surgical Nursing Princiapl KGMU College of Nursing Lucknow UP.
Lucknow
UTTAR PRADESH
226020
India |
| Phone |
9628180095 |
| Fax |
522-2257539 |
| Email |
rashmijohn@kgmcindia.edu |
|
Details of Contact Person
Public Query
|
| Name |
Rajendra Kumar jinjwaria |
| Designation |
student |
| Affiliation |
King george medical university lucknow |
| Address |
Room no 607, 6th floor kalam(Modern teaching block) centre KGMU Lucknow UP.
Room no 607, 6th floor kalam(Modern teaching block) centre KGMU Lucknow UP.
Lucknow
UTTAR PRADESH
226o20
India |
| Phone |
08871206912 |
| Fax |
522-2257539 |
| Email |
rajendra4137@gmail.com |
|
|
Source of Monetary or Material Support
|
| room no 2 3rd floor satabdi building ,Department of Physical Medicine and Rehabilitation(DPMR)KGMU LUCKNOW UP |
|
|
Primary Sponsor
|
| Name |
Rajendra Kumar Jinjwaria |
| Address |
Room no 607, 6th floor kalam(Modern teaching block) centre KGMU
Lucknow UP.
UTTAR PRADESH
pin code 226020
India |
| 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 Arvind kumar |
Shatabdi Hospital KGMU. |
Room no 2 3rd floor Department of Physical Medicine and Rehabilation (DPMR)KGMU Lucknow.
Lucknow
UTTAR PRADESH |
9839410532
arvindmspt@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee KGMU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D899||Disorder involving the immune mechanism, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydrotherapy exercises. |
1.Duration- 6 weeks ( weekly session).
2.Time- 30 minutes exercise
3.Water temperature (30-35 degree Celsius).
4.Exercises in hydrotherapy bath tub submerge body in water.
5.Set of exercises-
A)Stretching – (9 min).
a)In the sitting position, support with the wall of the pool, cross one leg over the other leg and place one hand on top of the foot to hold the toes; pull and hold and other hand support to body 2 min.
b)In the supine position, flexed both knees and rest both feet and raised the exercising limb for 1 min.
c)Lying on your side with the exercising limb on top and flexed with dorsiflexion of feet and change another leg with the same exercise for the 1 min.
d)In supine position straight both arm and hold 1 min.
e)In supine position flex both arms with internal and external rotation of both wrists for 1min.
f)In supine position flexion and extension of both and foot fingers and toe for 1 min.
g)In supine position flexion, extension, internal and external rotation of neck 2 times for 1 min.
h)In supine position with the support of buttocks and shoulder mid of back and abdomen slightly up and hold for 1 min.
B)Isometric strengthing– (9 min).
a)In the supine position, with both knees straight, perform dorsiflexion and hold for 3 min
b)In the supine position, with both knees straight, perform plantar flexion and hold 2 min
c)In the supine position, both elbows straight and perform dorsiflexion and hold for 2 min.
d)In the supine position, both elbows straight and perform plantar flexion and hold for 2 min.
C)Isotonic strengthening-(6 min).
a)In supine position with both knee and elbow flexed so that the feet and hand are resting comfortably in a flat position 6 min.
D)Gait training- (6 min).
a)Alternately move of both legs 3 min.
b)Cycling of both legs 3 minutes.
|
| Comparator Agent |
Clear Control GROUP. |
1)Duration-6 weeks (weekly exercises session).
2)Time-11 Minutes.
3)Exercises on land.
A)Stretching – (4 min).
a)In a sitting position, cross one leg over the other leg and place one hand on top of the foot to hold the toes; pull and hold and other hand support to body 30 seconds.
b)In the supine position, flexed both knees and rest both feet and raised the exercising limb for 30 seconds.
c)Lying on your side with the exercising limb on top and flexed with dorsiflexion of feet and change another leg with the same exercise for the 30 seconds.
d)In supine position straight both arm and hold 30 seconds.
e)In supine position flex both arms with internal and external rotation of both wrists for 30 seconds.
f)In supine position flexion and extension of both and foot fingers and toe for 30 seconds.
g)In supine position flexion, extension, internal and external rotation of neck 2 times. For 30 seconds.
h)In supine position with the support of buttocks and shoulder mid of back and abdomen slightly up and hold for 30 seconds.
B)Isometric strengthing– (3 min).
a)In the supine position, with both knees straight, perform dorsiflexion and hold for 1 min
b)In the supine position, with both knees straight, perform plantar flexion and hold 1 min
c)In the supine position, both elbows straight and perform dorsiflexion and hold for 30 Seconds.
d)In the supine position, both elbows straight and perform plantar flexion and hold for 30 Seconds.
C)Isotonic strengthening-(2 min).
a)In supine position with both knee and elbow flexed so that the feet and hand are resting comfortably in a flat position 2 min.
D)Gait training-(2 min).
a)Forward and backwards walk with the alternate movement of the upper and lower extremities 1 min.
b)Walk and raising the knee and try to touch abdomen with the leg 30 seconds.
c)Lateral walking for 30 seconds.
|
| Intervention |
Land-Based exercises. |
1)Duration- 6 weeks (weekly session).
2)Time- 30 minutes exercise
3)Exercises on land.
A)Stretching – (9 min).
a)In a sitting position, cross one leg over the other leg and place one hand on top of the foot to hold the toes; pull and hold and other hand support to body 2 min.
b)In the supine position, flexed both knees and rest both feet and raised the exercising limb for 1 min.
c)Lying on your side with the exercising limb on top and flexed with dorsiflexion of feet and change another leg with the same exercise for the 1 min.
d)In supine position straight both arm and hold 1 min.
e)In supine position flex both arms with internal and external rotation of both wrists for 1 min.
f)In supine position flexion and extension of both and foot fingers and toe for 1 min.
g)In supine position flexion, extension, internal and external rotation of neck 2 times. For 1 min.
h)In supine position with the support of buttocks and shoulder mid of back and abdomen slightly up and hold for 1 min.
B)Isometric strengthing– (9 min).
a)In the supine position, with both knees straight, perform dorsiflexion and hold for 3 min
b)In the supine position, with both knees straight, perform plantar flexion and hold 2 min
c)In the supine position, both elbows straight and perform dorsiflexion and hold for 2 min.
d)In the supine position, both elbows straight and perform plantar flexion and hold for 2 min.
C)Isotonic strengthening-(6 min).
a)In supine position with both knee and elbow flexed so that the feet and hand are resting comfortably in a flat position 6 min.
D)Gait training-(6 min).
a)Forward and backwards walk with the alternate movement of the upper and lower extremities 2 min.
b)Walk and raising the knee and try to touch abdomen with the leg 2 min.
c)Lateral walking for 2 min.
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult patient age from 17 to 75 years old suffering from chronic rheumatoid arthritis subject to written informed consent.
Able to use Numeric Rating Pain Scale and read and write and understand Hindi / English language.
|
|
| ExclusionCriteria |
| Details |
A patient does not come under the criteria of chronic Rheumatoid Arthritis.
Cognitive impairment.
Age less than 17 years and more than 75 years.
Weight more than 100 kg.
Height more than 7 feet.
Subjects who have undergone joint surgery or rehabilitation elsewhere for the last three months.
Systematic illness and cardio-respiratory dysfunction such as Patient suffering from poorly controlled epilepsy, hypotension and hypertension, diabetes mellitus, incontinence of faces, fear of water, pregnant women, methicillin-resistant staphylococcus aureus in the upper respiratory tract, fever, any communicable disease.
Unable to operate mobile or laptop.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Aim of this study is to evaluate the comparative effectiveness of hydrotherapy exercises versus land-based exercises to decrease pain and improve quality of life (QOL) among patient with Rheumatoid Arthritis. |
Time point will be 6 weeks.
(30 minutes weekly session for 6 weeks). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluate comparative effectiveness of hydrotherapy versus land based exercise among rheumatoid arthritis.
|
time point will be 6 weeks. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2021 |
| Date of Study Completion (India) |
30/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/09/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
https://doi.org/10.18203/2394-6040.ijcmph20230926 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The present study is focused on hydrotherapy versus land-based exercises on pain and quality of life (QoL) among patient with rheumatoid arthritis aiming to evaluate the comparative effectiveness of hydrotherapy exercises versus land-based exercises to decrease pain and improve quality of life (QOL) among patient with Rheumatoid Arthritis. Objectives of the study were to assess and compare the effect of hydrotherapy exercises versus land-based exercises of pain using a Numeric Rating Pain Scale, to assess and compare the effect of hydrotherapy exercises versus land-based exercises on quality of life using RJQOL-22 scale, to find out the association between the pre-test score of hydrotherapy versus land-based exercise of pain and quality of life with selected demographical variable and to find out the association between the pre-test score of hydrotherapy versus land-based exercise of pain and quality of life with selected clinical variable. |