Diabetes Mellitus, Type 2NCT04759469
Effect of Exercise on Cardiometabolic Risk Factors in Type II Diabetic Patients
A study testing High-intensity interval training and Moderate intensity interval training in people with Diabetes Mellitus, Type 2, run by Cairo University at 1 site in Egypt.
Trial summary
Background: Physical activity is known to modify some of the diabetes risk factors; however, solid evidence is still needed to precisely know the optimum form of training best fits the individual needs of type II diabetic (T2D) patients. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- High-intensity interval training and Moderate intensity interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Controlled type 2 diabetic patients who were clinically stable for at least 3 months before entering the study,
- Aged 45-65 years
- Non-smokers
- body mass index (BMI) ranged between 20 to 39.9 Kg/m2
- Fasting blood glucose ranged from (126-160) mg/dl
- Sedentary lifestyle who didn't engage in physical activity for more than half an hour/ day for at least one month before entering the study.
Who cannot join
- unstable medical condition
- smoker, recent surgery
- Body mass index is more than 39.9 kg/m2 or less than 20 kg/m2
- Any known musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Time-efficient Exercise Training on Cardiometabolic Risk Factors in Type II Diabetic Patients: A Randomized Mixed-methods Feasibility Study
Background: Physical activity is known to modify some of the diabetes risk factors; however, solid evidence is still needed to precisely know the optimum form of training best fits the individual needs of type II diabetic (T2D) patients.
Read the detailed description
Objectives: the purpose of this study was to compare between high intensity interval training (HIIT) and moderate-intensity interval training (MIIT) effect on functional capacity (as a cardiorespiratory parameter), and on glucose control and glycated hemoglobin (HbA1C) (as metabolic parameters) in T2D patients, and to test exercise acceptability within these patients. Methods: 60 participants had participated in this study. Their ages ranged from 45 to 65 years. They were randomized into two equal groups (30/group); group (A) did HIIT and group (B) did MIIT. Both groups received 12 weeks of training. Measurements for six minute walking distance (6MWD), fasting blood glucose (FBG), and HbA1C levels were done before and after the study. Physical activity enjoyment scale (PACES) were filled by the patients by the end of the study; testing exercise enjoyment.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- High-intensity interval training, Moderate intensity interval training
- Keywords
- Type II diabetes, cardiometabolic risk, high-intensity interval training
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingBehavioural
High-intensity interval training is a form of intermittent training using relatively high exercise intensity
Moderate intensity interval trainingBehavioural
Moderate intensity interval training is a form of intermittent training using moderate exercise intensity
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training (HIIT) | Experimental | A high-intensity interval training program for 3 days/week (day after day) for 12 weeks on atreadmill (Biodex RTM500, Biodex Inc., New York), with a gradual increase in the program intensity. Receives: Behavioral: High-intensity interval training |
| Moderate intensity interval training (MIIT) | Active comparator | A moderate intensity interval training program for 3 days/week (alternate days) on a treadmill (Biodex RTM500, Biodex Inc., New York), with a gradual increase in the program. Receives: Behavioral: Moderate intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
six minute walking distance (in meters)
represent aerobic capacity (distance walked in 6 min)
Measured: 12 weeks
Glycated Hemoglobin (HbA1C)
Representing glucose control over 120 days
Measured: 12 weeks
Fasting blood glucose
Representing glucose level after 9 hours fasting
Measured: 12 weeks
Exercise enjoyment and acceptability
The Physical Activity Enjoyment Scale (PACES) score, out of 119. It is an 18-item scale that assesses enjoyment for physical activity by asking participants to rate "how you feel at the moment about the physical activity you have been doing" using a 7-point bipolar Likert scale, from 1 (I enjoy it) to 7 (I hate it). Eleven items were negatively worded and seven items were positively worded. After reverse scoring the 11negatively worded items, an overall enjoyment for physical activity score is determined by summing the items, with a range of 18-126 being possible. Higher scores indicate higher enjoyment.
Measured: 12 weeks
Secondary outcomes (1)
Adherence rates
To what extent the patients will adhere to the exercise protocol
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Dec 2018
- Primary completion1 Dec 2018
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Responsible party
- Principal investigator, Hady Atef Labib, Cairo University
- Investigators
- Hady Atef, PhD, Study director, Lecturer of physical therapy, Cairo University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759469
- Sponsor's protocol ID
- HIIT on DM
- Status last verified
- Mar 2021
- First submitted
- 15 Feb 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After approval can be shared
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Time-efficient Exercise Training on Cardiometabolic Risk Factors in Type II Diabetic Patients: A Randomized Mixed-methods Feasibility Study
- ClinicalTrials.gov ID
- NCT04759469
- Acronym / sponsor ID
- HIIT on DM
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type II diabetes, cardiometabolic risk, high-intensity interval training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Physical activity is known to modify some of the diabetes risk factors; however, solid evidence is still needed to precisely know the optimum form of training best fits the individual needs of type II diabetic (T2D) patients.
Detailed description
Objectives: the purpose of this study was to compare between high intensity interval training (HIIT) and moderate-intensity interval training (MIIT) effect on functional capacity (as a cardiorespiratory parameter), and on glucose control and glycated hemoglobin (HbA1C) (as metabolic parameters) in T2D patients, and to test exercise acceptability within these patients. Methods: 60 participants had participated in this study. Their ages ranged from 45 to 65 years. They were randomized into two equal groups (30/group); group (A) did HIIT and group (B) did MIIT. Both groups received 12 weeks of training. Measurements for six minute walking distance (6MWD), fasting blood glucose (FBG), and HbA1C levels were done before and after the study. Physical activity enjoyment scale (PACES) were filled by the patients by the end of the study; testing exercise enjoyment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training (HIIT) | Experimental | Behavioral: High-intensity interval trainingA high-intensity interval training program for 3 days/week (day after day) for 12 weeks on atreadmill (Biodex RTM500, Biodex Inc., New York), with a gradual increase in the program intensity. |
| Moderate intensity interval training (MIIT) | Active comparator | Behavioral: Moderate intensity interval trainingA moderate intensity interval training program for 3 days/week (alternate days) on a treadmill (Biodex RTM500, Biodex Inc., New York), with a gradual increase in the program. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Controlled type 2 diabetic patients who were clinically stable for at least 3 months before entering the study,
- Aged 45-65 years
- Non-smokers
- body mass index (BMI) ranged between 20 to 39.9 Kg/m2
- Fasting blood glucose ranged from (126-160) mg/dl
Key exclusion criteria (4 listed)
- unstable medical condition
- smoker, recent surgery
- Body mass index is more than 39.9 kg/m2 or less than 20 kg/m2
- Any known musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity interval trainingHigh-intensity interval training is a form of intermittent training using relatively high exercise intensity | Behavioural | High-intensity interval training (HIIT) |
| Moderate intensity interval trainingModerate intensity interval training is a form of intermittent training using moderate exercise intensity | Behavioural | Moderate intensity interval training (MIIT) |
Primary outcome
six minute walking distance (in meters)
Time frame: 12 weeks
represent aerobic capacity (distance walked in 6 min)
Glycated Hemoglobin (HbA1C)
Time frame: 12 weeks
Representing glucose control over 120 days
Fasting blood glucose
Time frame: 12 weeks
Representing glucose level after 9 hours fasting
Exercise enjoyment and acceptability
Time frame: 12 weeks
The Physical Activity Enjoyment Scale (PACES) score, out of 119. It is an 18-item scale that assesses enjoyment for physical activity by asking participants to rate "how you feel at the moment about the physical activity you have been doing" using a 7-point bipolar Likert scale, from 1 (I enjoy it) to 7 (I hate it). Eleven items were negatively worded and seven items were positively worded. After reverse scoring the 11negatively worded items, an overall enjoyment for physical activity score is determined by summing the items, with a range of 18-126 being possible. Higher scores indicate higher enjoyment.
1 secondary outcome
Adherence rates
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Individual participant dataSharing planned: Yes. After approval can be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hady Atef, PhD study director
Lecturer of physical therapy, Cairo University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training and Moderate intensity interval training in people with Diabetes Mellitus, Type 2, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
six minute walking distance (in meters) (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.