Effect of resistance training on balance, postural control, risk of fall, reaction time and walking signs of neuropathy in type 2 diabetic patients with peripheral neuropathy - randomized controlled clinical trial
To investigate the effect of resistance training on postural control and clinical symptoms of diabetic neuropathy
Design
A randomized clinical trial with control group and parallel design, with no blinding and a sample size of 60
Settings and conduct
Three months supervised resistance training with the intensity of 50% to 60% of one repetition maximum with the frequency of 3 sessions per week will be conducted at the laboratory of sport physiology of Shahrood university of technology. Resistance training will include 10 exercises of 4 upper body , 4 lower body and 2 core exercises. The measurements will be performed at baseline and 48 hours following the last exercise session in a fasting state. It is impossible to blind the participants and instructor to group allocation but laboratory specialists assessing the variables and data analyst will be blinded to the group allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range of 30-70 years, Diagnosis of Type 2 diabetes for more than 5 years, HbA1c over 6.6%, Sedentary life-style, No restriction for exercise
Intervention groups
Resistance training group: participants will undergo resistance training over 3 months with the frequency of 3 days a week at the intensity of 50 to 70% of one repetition maximum.
Control group: they will be required to maintain daily physical activity
Main outcome variables
Balance, walking, postural control, risk of falling, reaction time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170120032066N2
Registration date:2018-12-31, 1397/10/10
Registration timing:prospective
Last update:2018-12-31, 1397/10/10
Update count:0
Registration date
2018-12-31, 1397/10/10
Registrant information
Name
Farhad Gholami
Name of organization / entity
Shahrood University of Technology
Country
Iran (Islamic Republic of)
Phone
+98 41332395900
Email address
gholami-fa@shahroodut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2019-02-04, 1397/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of resistance training on balance, postural control, risk of fall, reaction time and walking signs of neuropathy in type 2 diabetic patients with peripheral neuropathy - randomized controlled clinical trial
Public title
Effect of resistance training on postural control parametes and clinical symptoms in diabetic peripheral neuropathy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age ranges from 30 to 70 years
Diagnosis of type 2 diabetes for more than 5 years
HbA1c over 6.6%
Sedentary life-style
No restriction for exercise
Exclusion criteria:
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be enrolled by one of the research colleagues. An independent evaluator, blinded to group allocation will provide a random allocation sequence using computer software of SAS prior to the initiation of the study that will be used to randomize participants with 1:1 allocation ratio. A block randomization design (block size of 4, 6) will be applied to ensure an equal number of participants in each group. Group allocation will be concealed in sequentially numbered, opaque, sealed envelopes, and corresponding envelopes will be opened after enrolled participants completed all baseline assessments. It is impossible to blind the participants and instructor to group allocation but laboratory specialists assessing the variables and data analyst will be blinded to the group allocation.
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
Ethics Committee of Shahroud University of Medical Sciences
Street address
7-Tir Square., Tehran St.
City
Shahrud
Province
Semnan
Postal code
3614773947
Approval date
2018-07-23, 1397/05/01
Ethics committee reference number
IR.SHMU.REC.1397.086
Health conditions studied
1
Description of health condition studied
Peripheral Neuropathy Type 2 Diabetes
ICD-10 code
E11.42
ICD-10 code description
Type 2 diabetes mellitus with diabetic polyneuropathy
Primary outcomes
1
Description
Balance index
Timepoint
Before and after the intervention.
Method of measurement
Balance will be measured using Tendom test.
2
Description
Risk of falling
Timepoint
Before and after the intervention.
Method of measurement
Risk of falling will be assessed with the international questionnaire of falling efficiency
3
Description
Posture control
Timepoint
Before and after the intervention.
Method of measurement
Posture control will be assessed using foot scanner.
4
Description
Reaction time
Timepoint
Before and after the intervention.
Method of measurement
Reaction time will be assessed with reaction analyzer
5
Description
Score of neuropathy symptomes
Timepoint
Before and after the intervention.
Method of measurement
Neuropathy score will be assessed using Michigan diabetic neuropathy score.
Secondary outcomes
1
Description
Fasting blood glucose
Timepoint
Before and after the intervention
Method of measurement
Blood glucose level will be measured using Pars-azmoon kit with calorimetric method.
Intervention groups
1
Description
Intervention group: Resistance exercise over 3 months with the frequency of 3 sessions per week and 36 sessions in total, with the intensity of 50-70% of one repetition maximum
Category
Rehabilitation
2
Description
Control group: no further activity other than daily physical activity
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Pasargad Clinic of Shahrood
Full name of responsible person
Farhad Gholami
Street address
7-Tir Square., Tehran St.
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 5900
Email
info@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud Unversity of Technology
Full name of responsible person
Ali Dastfan
Street address
7-Tir Square,. Tehran St.
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 5900
Email
info@shahroodut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud Unversity of Technology
Proportion provided by this source
100
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
Shahrood University of Technology
Full name of responsible person
Farhad Gholami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
7-Tir Square,. Tehran St.
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 5900
Fax
Email
gholami-fa@shahroodut.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroot University of Technology
Full name of responsible person
Farhad Gholami
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Tehran St., 7-Tir Square
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 32395900
Email
gholami-fa@shahroodut.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahrood University of Technolgy
Full name of responsible person
Farhad Gholami
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Exericse physiology
Street address
7-Tir Square., Tehran St.
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 32395900
Email
gholami-fa@shahroodut.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available