Effect of water exercises on falling risk factors in the Neuropathy– Diabetic patients
Design
The present research is a randomized, controlled, prospective randomized clinical trial with parallel groups.
Settings and conduct
The present study will be carried out at the research Center of Kermanshah University of Medical Sciences. Because of the nature of the study, the participants are not blind to the division into groups, but statisticians and evaluators split the participants into groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria were included; Age over 65 years old; clinical confirmation of type 2 diabetes with peripheral neuropathy; lower limb symptoms of peripheral neuropathy; ability to walk home without help or with aides; definitive electrodiagnostic evidences of peripheral neuropathy
Exclusion criteria were included; Severe cardiovascular disease; unstable proliferative retinopathy; end-stage renal disease and uncontrolled high blood pressure; severe structural abnormalities of the lower extremity; history or evidence of vestibular dysfunction; history with evidence of plantar pressure ulcer
Intervention groups
The water treatment group participates in a 10-week water exercise program, 3 sessions a week, and 40-70 minutes per session. Each training session is guided by a trained sports trainer under the supervision of researchers. The water level with an average temperature of 30 ° C is considered constant within the boundary of the dagger appendage. The training program includes: tensile and warm-up exercises (10 minutes), endurance training (20 minutes walking and dancing), resistance training (15 minutes), balance exercises (15 minutes), and relaxation / cooling training (5 minutes).
Main outcome variables
Fear of falling; Static and Dynamic Balance; Reaction time; Fall index; Frequency of fall
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170114031942N10
Registration date:2018-09-21, 1397/06/30
Registration timing:registered_while_recruiting
Last update:2018-09-21, 1397/06/30
Update count:0
Registration date
2018-09-21, 1397/06/30
Registrant information
Name
Aynollah Naderi
Name of organization / entity
Shahrood University of Technology
Country
Iran (Islamic Republic of)
Phone
+98 917 721 7462
Email address
ay.naderi@shahroodut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
2018-08-30, 1397/06/08
Actual recruitment end date
2018-09-23, 1397/07/01
Trial completion date
2018-08-14, 1397/05/23
Scientific title
Effects of water based exercise on falling risk factors in the patients with diabetic neuropathy
Public title
Water based exercise and diabetic neuropathy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 65 years old
Clinical confirmation of type 2 diabetes with peripheral neuropathy
Lower limb symptoms of peripheral neuropathy
Ability to walk home without help or with aids
Definitive electrodiagnostic evidences of peripheral neuropathy
Exclusion criteria:
Severe cardiovascular diseaseHistory with evidence of plantar pressure ulcer
unstable proliferative retinopathy
End-stage renal disease and uncontrolled high blood pressure
severe structural abnormalities of the lower extremity
History or evidence of vestibular dysfunction
History with evidence of plantar pressure ulcer
Age
From 65 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
46
Actual sample size reached:
46
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate the participants in the research groups, a computerized list of random numbers for assigning random subjects to blocks (2, 4, 6, 8) was determined using the SPSS software by the statistical consultant. Then, the assignment of the participants is carried out by one of the research team members who are not associated with the 1: 1 assignment ratio within the training and control groups. Assignment sequences are hidden by the envelopes encoded in the order numbered, and the letter envelopes are opened only after all the initial and initial evaluations of the participants have been made.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Beheshti Blvd, Kermanshah , Kermanshah Province
City
kermansah
Province
Kermanshah
Postal code
6761753164
Approval date
2018-08-14, 1397/05/23
Ethics committee reference number
IR.KUMS.REC.1397.411
Health conditions studied
1
Description of health condition studied
Diabetic neuropathy
ICD-10 code
E11.40
ICD-10 code description
Type 2 diabetes mellitus with diabetic neuropathy, unspecified
Primary outcomes
1
Description
Fear of falling
Timepoint
Measure the fear of falling at the beginning of the study (before the intervention) and 12 and 24 weeks after the beginning of the water base exercise program.
Method of measurement
Fall Efficacy Scale International
Secondary outcomes
1
Description
Static and Dynamic Balance
Timepoint
Measure the static and dynamic balance at the beginning of the study (before the intervention) and 12 and 24 weeks after the beginning of the exercise program.
Method of measurement
Frailty and Injuries: Cooperative Studies of Intervention Techniques–4 and Dynamic Gait Index
2
Description
Reaction time
Timepoint
Measure the reaction time at the beginning of the study (before the intervention) and 12 and 24 weeks after the beginning of the water base exercise program.
Method of measurement
Switch Mat
3
Description
Fall index
Timepoint
Measure the fall index at the beginning of the study (before the intervention) and 12 and 24 weeks after the beginning of the water base exercise program.
Method of measurement
Physiological Profile Assessment
Intervention groups
1
Description
Intervention group: The water treatment group participates in a 10-week water exercise program, 3 sessions a week, and 40-70 minutes per session. Each training session is guided by a trained sports trainer under the supervision of researchers. The water level with an average temperature of 30 ° C is considered constant within the boundary of the dagger appendage. The training program includes: tensile and warm-up exercises (10 minutes), endurance training (20 minutes walking and dancing), resistance training (15 minutes), balance exercises (15 minutes), and relaxation / cooling training (5 minutes).
Category
Prevention
2
Description
Control group: Participants in this group receive only routine pre-care and no new intervention is granted to them.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized and specialized clinics for diabetes and metabolic diseases in the city of Kermanshah
Full name of responsible person
Alireza Hassani
Street address
No. 11, Third alley, taghbostan street
City
Kermansah
Province
Kermanshah
Postal code
6761753164
Phone
+98 83 4522 6103
Email
asakenapoor@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Abas Seidi
Street address
No. 32,alley 18, street bolvar shaid bahsti
City
Kermansah
Province
Kermanshah
Postal code
6761753164
Phone
+98 83 4522 6103
Email
asakenapoor@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
10
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ainollah Sakinepoor
Position
Teacher
Latest degree
Master
Other areas of specialty/work
علوم ورزشی
Street address
Street tagbostan, Kermanshah Preovience
City
Kermansah
Province
Fars
Postal code
6761753164
Phone
+98 83 4522 6103
Email
asakenapoor@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Dr Aynollah Naderi
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Sport scince
Street address
Shahrood University of Technology, Shahroud, Semnan Province, Iran
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Fax
Email
ay.naderi@yahoo.com
Web page address
http://www.shahroodut.ac.ir/fa/
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ainollah sakinepoor
Position
teacher
Latest degree
Master
Other areas of specialty/work
Sport Scince
Street address
Bolvar behsiti, Kermanshah
City
Kermansah
Province
Kermanshah
Postal code
6761753164
Phone
+98 83 4522 6103
Email
asakenapoor@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD