Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000631303
Ethics application status
Approved
Date submitted
20/02/2017
Date registered
1/05/2017
Date last updated
8/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
High-Intensity Interval versus high-intensity resistance training on glycated hemoglobin and blood glucose levels in prediabetic individuals
Scientific title
A comparison between High-Intensity Interval versus high-intensity resistance training on glycated hemoglobin and blood glucose levels in prediabetic individuals
Secondary ID [1] 291225 0
Nil known
Universal Trial Number (UTN)
U1111-1193-2658
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pre-diabetic 302144 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301756 301756 0 0
Physiotherapy
Metabolic and Endocrine 301757 301757 0 0
Diabetes
Physical Medicine / Rehabilitation 301758 301758 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be randomly assigned into three equal numbers (n=20) into one of the three groups: High-intensity interval exercise, high intensity Resistance training, Control group. The exercise programme will be determined in accordance with the American collage of sport medicine (ACSM) guidelines (ACSM,2006).
Parameters
1- All the subjects in 3 groups will be recommended to follow a low caloric diets for the 12 week intervention period. A low-calorie diet is usually used to achieve weight loss of 1 lb (0.5 kg) to 2 lb (0.9 kg) per week. Reducing calorie intake to 1,200 to 1,500 calories per day for women and 1,500 to 1,800 calories per day for men. Additionally, limiting fat intake to no more than 20% to 35% of the total calorie intake. Also, choosing complex carbohydrates, such as whole grains, vegetables, and fruits. About 45% to 65% of the total calorie intake will come from carbohydrate. Choosing low-fat protein sources, such as fish, poultry, and legumes (for example, pinto beans, lentils, and split peas). About 15% to 25% of the total calorie intake will come from protein. Adherence to the diet will be assessed with a diet log book, where every participant will be asked to document each meal they had everyday for 3 months of the intervention. Only one day per week will be allowed for each participant to eat what ever they want, and will also be documented in the diet log book.
2- Furthermore, subjects of the control group will be instructed to maintain their present lifestyle until the end of the project. Baseline biochemical tests will include glycated hemoglobin (HbA1c), fasting and post-prandial blood glucose (FBG)will be collected both before and 3 months at the end of the intervention period.
These tests will also be repeated by their physicians at 3-monthly visits. All of the subjects will repeatedly monitor their blood sugar tests using a glucometer. Their heart rate and blood pressure will be measured.

3- Exercise training protocol
All exercises will be held in the out-patient clinical of the faculty of Physical Therapy, Cairo University. Two experienced physical therapist with more than 7 years of experience will deliver each exercise program. The exercise sessions will be regularly held two or three times a week with the close supervision of the experienced physical therapists and trainers. Moreover, the probability of hypoglycaemic episodes during the sessions will be monitored and blood pressure fluctuations will be assessed regularly. Subjects will be asked not to have lunch before the exercise program, however if any hypo-glycaemic episodes, sweet items will be available. All types of exercise training were done according to the ACSM guidelines. All sessions will include 10-15 minutes of stretching and flexibility movements to warm up as well as 10-15 minutes of relaxation activities to cool down. To monitor adherence to exercise sessions, registration for attendance will be recorded.

a- Group A: High-Intensity Interval Training (HIIT): HIIT involves short bursts of activity followed by a short period of rest or recovery, these exercise programs are usually performed in less than 30 minutes. Typically, the work intervals last from 15 seconds to 4 minutes and approach 80% to 95% of an individual’s maximum heart rate. Recovery intervals are generally equal to or slightly longer than the intense work interval and consist of passive rest or mild activity at 40% to 50% of the maximum heart rate. The combined work/rest interval commonly is repeated 6 to 10 times. Thus, the total HIIT exercise time ranges from 10 to 40 or more minutes depending on the actual duration of the work and rest periods. Participants in group A will be submitted to a 30 min HIIT aerobic session on a treadmill. The initial 5-min warm-up phase will be performed on the treadmill at a low load. Each training session will last 30 min and end with a 5-min recovery and relaxation phase either walking or running, based on heart rate, until the target heart rate according to the ACSM guidelines will be reached.
The programme will begin with 10 min of stretching exercises for the major muscles of the upper and lower limbs and will be conducted using the maximal heart rate index (HRmax) estimated by: 220-age. First 2 weeks =60–80% of HRmax, 3rd to 12th weeks= 80–90% of HRmax .( Abd El-Kader, 2011). The protocol will start on 2 days of the week during the first month and will increase to 3 non-consecutive days per week for the remaining 2 months.
B- Group B: High-intensity Resistance training program
Patients in group B were submitted to a 40 min session of resistance training.
The programme will begin with 10 min of stretching for the major muscles of the upper and lower limbs and then exercises on seven resistance machines will be conducted.
The manual resistance machines that will be used are; shoulder press,bench press,seated bicep curl, triceps push down, lateral pull down, abdominals crunch, and leg extension.
The protocol will start on 2 days of the week during the first month and will increase to 3 non-consecutive days per week. Training will start during weeks 1 and 2 with intensity 60% one-repetition maximum (1RM) and will progress to intensity 75% 1RM.The number of sets will be 1-2 during the first month. Participants will perform 3 sets of 8-10 repetitions (with a 90- 120 s rest between sets) for 40 minutes.(yavari et al.,2012).
Intervention code [1] 297227 0
Prevention
Intervention code [2] 297228 0
Rehabilitation
Comparator / control treatment
Control group C did not performed any type of exercises.
Control group
Active

Outcomes
Primary outcome [1] 301157 0
Baseline biochemical tests; glycated hemoglobin (HbA1c), will be performed using Cobas Integra Tina-quant Hemoglobin A1c Gen.2 kit (Roche Diagnostics, GmbH, Sandhofer Strasse 116, D/68305 Mannheim, Germany).

Timepoint [1] 301157 0
At baseline and 3 months at the end of the intervention
Secondary outcome [1] 331876 0
Fasting blood glucose (FBG) using Cobas Integra Tina-quant Hemoglobin A1c Gen.2 kit (Roche Diagnostics, GmbH, Sandhofer Strasse 116, D/68305 Mannheim, Germany).
Timepoint [1] 331876 0
At baseline and 3 months at the end of the intervention
Secondary outcome [2] 333843 0
Post-prandial blood glucose using Cobas Integra Tina-quant Hemoglobin A1c Gen.2 kit (Roche Diagnostics, GmbH, Sandhofer Strasse 116, D/68305 Mannheim, Germany).
Timepoint [2] 333843 0
At baseline and 3 months at the end of the intervention

Eligibility
Key inclusion criteria
1- pre-diabetics individuals: having a fasting plasma glucose concentration between 100 to 125 mg/dl (5.6–6.9 mmol/l) and HbA1c between 5.6% and 6.4% (ADA.,2012).
2- overweight with a body mass index (BMI) of is 25.0 to less than 30, where this falls within the overweight range
3- an inactive previous lifestyle, A1c level < 6.4%.
Minimum age
25 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
BMI>40,Diabetes, recent blood loss, hemolytic anemia, or genetic differences in the hemoglobin molecule (hemoglobinopathy) such as sickle-cell disease and other conditions, as well as those that have donated blood recently, pregnant women, severe retinopathy, nephropathy and neuropathy, history of serious cerebrovascular or cardiovascular diseases, and severe musculoskeletal problems restricting physical activity.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2017
Actual
12/05/2017
Date of last participant enrolment
Anticipated
30/06/2017
Actual
6/08/2017
Date of last data collection
Anticipated
30/09/2017
Actual
6/11/2017
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 8679 0
Egypt
State/province [1] 8679 0
Cairo

Funding & Sponsors
Funding source category [1] 295675 0
Self funded/Unfunded
Name [1] 295675 0
Mary Kamal Nassif Takla
Country [1] 295675 0
Egypt
Primary sponsor type
University
Name
Cairo University
Address
School of Physical therapy, Cairo university 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. 11432
Country
Egypt
Secondary sponsor category [1] 294523 0
None
Name [1] 294523 0
Address [1] 294523 0
Country [1] 294523 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296990 0
The Board Council of Higher Education of the School of Physical Therapy, Cairo university
Ethics committee address [1] 296990 0
El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432
Ethics committee country [1] 296990 0
Egypt
Date submitted for ethics approval [1] 296990 0
07/01/2017
Approval date [1] 296990 0
14/01/2017
Ethics approval number [1] 296990 0
Ethics committee name [2] 296991 0
Institutional Review Board of Higher Education and Research of Cairo University
Ethics committee address [2] 296991 0
1 Cairo University Rd, Giza, Giza Governorate. 12613
Ethics committee country [2] 296991 0
Egypt
Date submitted for ethics approval [2] 296991 0
21/01/2017
Approval date [2] 296991 0
28/01/2017
Ethics approval number [2] 296991 0

Summary
Brief summary
Background: Prediabetic individuals have higher blood glucose levels than normal people, but not yet high enough to be diagnosed as diabetes. Prior to the development to type 2 diabetes, they almost always have prediabetes. Purpose: The purpose of this study is to investigate and compare between aerobic and resisted exercises on glycated hemoglobin (HbA1c) and fasting and post-prandial blood glucose (FBG) in prediabetics. Subjects: Sixty subjects with HbA1C (5.7-6.4) , will be recruited from the local community via flyers and advertisements. Their age will range from 25-45years. Participants will be divided into 3 equal groups; Aerobic group (A), Resisted group (B) and Control group (C). Procedure: Group A will receive aerobic exercise with intensity 60-75% of maximum heart rate (MHR), for 30 -40 min. Group B will receive resisted exercise with moderate intensity 60-75% of 1 maximum repetition (1RM). Control group C will not receive any type of exercises. The exercises given to groups A,B will performed for 3 months, 2-3 times per week. Participants in all groups will be instructed to follow a low caloric diet during the duration of the study. HbA1c and FBG will be measured before and after 3 months of the treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72638 0
A/Prof Mary Kamal Nassif Takla
Address 72638 0
School of Physical Therapy, Cairo University. El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432
Country 72638 0
Egypt
Phone 72638 0
+201222817512
Fax 72638 0
Email 72638 0
[email protected]
Contact person for public queries
Name 72639 0
A/Prof Mary Kamal Nassif Takla
Address 72639 0
School of Physical Therapy, Cairo University. El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432
Country 72639 0
Egypt
Phone 72639 0
+201222817512
Fax 72639 0
Email 72639 0
[email protected]
Contact person for scientific queries
Name 72640 0
A/Prof Mary Kamal Nassif Takla
Address 72640 0
School of Physical Therapy, Cairo University. El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432
Country 72640 0
Egypt
Phone 72640 0
+201222817512
Fax 72640 0
Email 72640 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of different dosages of interval training on glycemic control in people with prediabetes: A randomized controlled trial.2019https://dx.doi.org/10.2337/ds18-0024
N.B. These documents automatically identified may not have been verified by the study sponsor.