Aim of the study is to explore the effects of massage therapy with and without aerobic exercises on glucose, blood pressure and diabetic peripheral neuropathy
Design
94 Patients will be randomized into treatment group(47) and control group(47) by lottery method. It is a single blinded randomized controlled trail. In this study patients will be completely blinded about intervention protocol
Settings and conduct
Muhammad physical therapy clinic and rehabilitation cenetr, Al khaliq hospital, Multicare physical therapy clinic Multan
Participants/Inclusion and exclusion criteria
Patients with diabetic peripheral neuropathy and hypertension will be included in this study. Patients with angina, stroke, myocardial infarctio, acute illness and any fracture of the lower limb will be excluded from this study
Intervention groups
Group 1 will be treatment group in which patients receive massage therapy with aerobic exercises(cycling and walking) and group 2 will be control group in which patients receive massage therapy alone.
Main outcome variables
Blood pressure, glucose level and neuropathic pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220603055065N1
Registration date:2022-06-22, 1401/04/01
Registration timing:prospective
Last update:2022-06-22, 1401/04/01
Update count:0
Registration date
2022-06-22, 1401/04/01
Registrant information
Name
Hafiza Iram Batool
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences Multan
Country
Pakistan
Phone
+92 304 0134576
Email address
hafizairam@mimas.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-25, 1401/04/04
Expected recruitment end date
2022-08-31, 1401/06/09
Actual recruitment start date
2022-06-25, 1401/04/04
Actual recruitment end date
2022-08-31, 1401/06/09
Trial completion date
2022-08-31, 1401/06/09
Scientific title
Effects of massage therapy with and without aerobic exercises on glucose, blood pressure and diabetic peripheral neuropathy
Public title
Effects of massage therapy with and without aerobic exercises on glucose, blood pressure and diabetic peripheral neuropathy
Patients simply randomized into two groups by using convenient sampling technique. Patients will be randomized by lottery method (Draw numbers from the box randomly to choose samples).
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyzer will be blinded when analyze the data that which group has which outcome. So, data analyzer will be completely blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Patients will be included in this study by filling questionnaire about diabetes
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences, Multan.
Street address
HBL street, near sabzazar ,etro station, bosan road Multan
City
Multan
Postal code
60700
Approval date
2021-11-10, 1400/08/19
Ethics committee reference number
2021/IRB/12/PT/12
Health conditions studied
1
Description of health condition studied
Diabetic peripheral neuropathic patients
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition neuropathy
Primary outcomes
1
Description
Diabetic peripheral neuropathy
Timepoint
Patients will be evaluate before and after treatment seesion
With the help of sphygmomanometer and stethoscope for blood pressure and neuropathy pain scale for neuropathic pain
Intervention groups
1
Description
Treatment group: Patients of treatment group receive massage therapy with aerobic exercises. After taking consent from patients they will be assess by using questionnaire for diabetes, pin-prick testing, neuropathy pain scale will be used to check pain, and blood pressure will be monitor by sphygmomanometer and stethoscope. Glucose level will be checked by glucometer. Aerobic exercises include 4-minute walking on electronic treadmill and 6-minute cycling on stationary bicycle. Session lasted for four days per week for six weeks. Glucose level, blood pressure and neuropathic pain will be measured before and after treatment sessions.
Category
Treatment - Devices
2
Description
Control group: Patients of control group receive massage therapy alone. After taking consent from patients they will be assess by using questionnaire for diabetes, pin-prick testing, neuropathy pain scale will be used to check pain, and blood pressure will be monitor by sphygmomanometer and stethoscope. Glucose level will be checked by glucometer. Glucose level, blood pressure and neuropathic pain will be measured before and after treatment sessions.Treatment session lasted for four days per week for six weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Muhammad Institute of Medical and Allied Sciences, Multan
Full name of responsible person
Dr. Nimra Arif
Street address
HBL street, near sabzazar metro station, Bosan road Multan
City
Multan
Postal code
60700
Phone
+92 304 0134576
Email
angelnimra95@gmail.com
Web page address
http://mimas.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan
Full name of responsible person
Imran Ahmad Khan
Street address
HBL strret, near sabzazar metro station, bosan road Multan
City
Multan
Postal code
60700
Phone
+92 304 0134576
Email
imranahmadkhandurrani@gmail.com
Web page address
http://mimas.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Muhammad Institute of Medical and Allied Sciences, Multan
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan
Full name of responsible person
Dr. Nimra Arif
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
HBL, street near sabzazar metro station, bosan road Multan
City
Multan
Province
Punjab
Postal code
60700
Phone
+92 333 3877032
Email
angelnimra95@gmail.com
Web page address
http://mimas.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan
Full name of responsible person
Imran Ahmad Khan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Cardiology
Street address
HBL street, near sabzazar metro station, Bosan road Multan
City
Multan
Province
Punjab
Postal code
60700
Phone
+92 304 0134576
Email
imranahmadkhandurrani@gmail.com
Web page address
http://www.mimas.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences Multan
Full name of responsible person
Dr. Nimra Arif
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
HBL street, near sabzazar metro station, Bosan road Multan
City
Multan
Province
Punjab
Postal code
60700
Phone
+92333877032
Email
angelnimra95@gmail.com
Web page address
http://mimas.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Title of my study effects of massage therapy with and without aerobic exercises on glucose, blood pressure and diabetic peripheral neuropathy. The basic purpose of my study is to assess the effects of massage therapy with aerobic exercises on diabetic peripheral neuropathic patients. A randomized controoled trial will be cinducted at Muhammad physical therapy clinic and rehabilitation center Multan. 94 subjects will be selected who met the inclusion criteria will be randomized into two groups, tratement group(1) and control group(2). Sampling technique is Convenient. Group 1 receive massage therapy with aerobic exercises(cycling and walking) and group 2 receive massage therapy alone.
When the data will become available and for how long
This expected that this study or data will be available at the end of this year 2022, no exact date can be expected.