Diabetes Mellitus, Type 2NCT06020846
Effect of Soleus Pushup Exercise in Type 2 Diabetes Patients
A study testing Soleus Pushup Exercise and treadmill walk group 2 in people with Diabetes Mellitus, Type 2, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this research is to compare the immediate effects of one hour Soleus Pushup Exercise and treadmill walk in Type 2 Diabetic population on blood glucose level. Randomized controlled trials done at Railway General Hospital and diabetic centers of Rawalpindi and Islamabad.. The sample size was 66. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Soleus Pushup Exercise and treadmill walk group 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2023to 15 Feb 2024
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Both male and female individuals
- Individuals with age between 40 to 60 years
- Individuals with clinically diagnosed diabetes type 2 up to 10 years
- individuals not engaged in a structured walking/exercise program
- 2 hours post meal with glucose ranging upto 200.
Who cannot join
- • No recent or planned changes in diet, physical activity, or medications.
- Participants diagnosed with pre-diabetes, gestational diabetes, or type 1 diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Immediate Effects of Soleus Pushup Exercise and Treadmill Walk on Blood Glucose Levels in Type 2 Diabetes Population.
The aim of this research is to compare the immediate effects of one hour Soleus Pushup Exercise and treadmill walk in Type 2 Diabetic population on blood glucose level. Randomized controlled trials done at Railway General Hospital and diabetic centers of Rawalpindi and Islamabad.. The sample size was 66. The subjects were divided in two groups, 33 subjects in Soleus Pushup Exercise group and 33 subjects in treadmill walk group. Study duration was of 6 months. Sampling technique applied was non probability convenience sampling technique. Only 40-60 years diabetic people with clinically diagnosed type 2 Diabetes for upto 10 years were included. Tools used in the study are Glucometer
Read the detailed description
Diabetes is on the rise worldwide, with a global prevalence in adults in 2021 being 537 million adults (20-79 years) living with diabetes -one in ten. This number is predicted to rise to 643 million by 2030 and 783 million by 2045. Over 3 in 4 adults with diabetes live in low- and middle-income countries. Although physical activity (PA) is a key element in the prevention and management of type 2 diabetes. Structured interventions combining Physical Activity and modest weight loss have been shown to lower type 2 diabetes risk by up to 58% in high-risk populations. The increase in T2DM prevalence can only partly be attributed to the increasing prevalence of obesity and a sedentary lifestyle. The exercise recommendations for individuals with type 2 diabetes are similar as for the general population, suggesting a minimum of 150 min of moderate-vigorous-intensity aerobic exercise each week. However, the general population doesn't adhere to these guidelines.
The goal of treatment in type 2 diabetes is to achieve and maintain optimal BG, lipid, and blood pressure (BP) levels to prevent or delay chronic complications of diabetes. A fundamental principle in exercise physiology is that a small muscle mass working in isolation can achieve a higher local oxygen consumption (VO2/min per kg) than when recruiting a large muscle mass. The soleus (1% body mass) has a highly pennated architecture favoring greater amounts of muscular work during plantarflexion. It has an exceptionally high physiological cross-sectional area (3-8 times more than most of the 20 other limb muscles studied).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Soleus Pushup Exercise, treadmill walk group 2
- Keywords
- diabetes mellitus, type 2, soleus push up, treadmill walk, blood glucose
- 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.
Soleus Pushup ExerciseOther
Patient will be seated on a chair, his legs at 90 degrees to the floor, keep the toes, and feet flat on the ground, and move his heels up and down continuously.
4 sets of 15 minutes each,1hour total intervention time
treadmill walk group 2Other
The patient will do treadmill walk at normal walking speed, 4 sets of treadmill walk for 15 minutes each, 1hour total intervention time
| Study group | Role | What they receive |
|---|---|---|
| Soleus Pushup Exercise group A | Experimental | soleus push up exercise Receives: Other: Soleus Pushup Exercise |
| Treadmill group 2 | Active comparator | treadmill walk Receives: Other: treadmill walk group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose level
The blood glucise level will be measured by the glucometer at base line , 30 min and at 60 min
Measured: baseline to 30 minutes and 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start1 Sep 2023
- Primary completion30 Jan 2024
- Study completion15 Feb 2024
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 Riphah International 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aisha Razzaq, MSPT-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020846
- Sponsor's protocol ID
- RiphahIU Ume Farva
- Status last verified
- May 2024
- First submitted
- 26 Aug 2023
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Immediate Effects of Soleus Pushup Exercise and Treadmill Walk on Blood Glucose Levels in Type 2 Diabetes Population.
- ClinicalTrials.gov ID
- NCT06020846
- Acronym / sponsor ID
- RiphahIU Ume Farva
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes mellitus, type 2, soleus push up, treadmill walk, blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 1 Sep 2023 (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.
The aim of this research is to compare the immediate effects of one hour Soleus Pushup Exercise and treadmill walk in Type 2 Diabetic population on blood glucose level. Randomized controlled trials done at Railway General Hospital and diabetic centers of Rawalpindi and Islamabad.. The sample size was 66. The subjects were divided in two groups, 33 subjects in Soleus Pushup Exercise group and 33 subjects in treadmill walk group. Study duration was of 6 months. Sampling technique applied was non probability convenience sampling technique. Only 40-60 years diabetic people with clinically diagnosed type 2 Diabetes for upto 10 years were included. Tools used in the study are Glucometer
Detailed description
Diabetes is on the rise worldwide, with a global prevalence in adults in 2021 being 537 million adults (20-79 years) living with diabetes -one in ten. This number is predicted to rise to 643 million by 2030 and 783 million by 2045. Over 3 in 4 adults with diabetes live in low- and middle-income countries. Although physical activity (PA) is a key element in the prevention and management of type 2 diabetes. Structured interventions combining Physical Activity and modest weight loss have been shown to lower type 2 diabetes risk by up to 58% in high-risk populations. The increase in T2DM prevalence can only partly be attributed to the increasing prevalence of obesity and a sedentary lifestyle. The exercise recommendations for individuals with type 2 diabetes are similar as for the general population, suggesting a minimum of 150 min of moderate-vigorous-intensity aerobic exercise each week. However, the general population doesn't adhere to these guidelines.
The goal of treatment in type 2 diabetes is to achieve and maintain optimal BG, lipid, and blood pressure (BP) levels to prevent or delay chronic complications of diabetes. A fundamental principle in exercise physiology is that a small muscle mass working in isolation can achieve a higher local oxygen consumption (VO2/min per kg) than when recruiting a large muscle mass. The soleus (1% body mass) has a highly pennated architecture favoring greater amounts of muscular work during plantarflexion. It has an exceptionally high physiological cross-sectional area (3-8 times more than most of the 20 other limb muscles studied).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soleus Pushup Exercise group A | Experimental | Other: Soleus Pushup Exercisesoleus push up exercise |
| Treadmill group 2 | Active comparator | Other: treadmill walk group 2treadmill walk |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Both male and female individuals
Key exclusion criteria (2 listed)
- • No recent or planned changes in diet, physical activity, or medications.
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 |
|---|---|---|
| Soleus Pushup ExercisePatient will be seated on a chair, his legs at 90 degrees to the floor, keep the toes, and feet flat on the ground, and move his heels up and down continuously. 4 sets of 15 minutes each,1hour total intervention time | Other | Soleus Pushup Exercise group A |
| treadmill walk group 2The patient will do treadmill walk at normal walking speed, 4 sets of treadmill walk for 15 minutes each, 1hour total intervention time | Other | Treadmill group 2 |
Primary outcome
Blood glucose level
Time frame: baseline to 30 minutes and 60 minutes
The blood glucise level will be measured by the glucometer at base line , 30 min and at 60 min
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 21 May 2024.
- Individual participant dataSharing planned: No
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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.
Aisha Razzaq, MSPT-OMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soleus Pushup Exercise and treadmill walk group 2 in people with Diabetes Mellitus, Type 2, run by Riphah International University at 1 site in Pakistan.
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 5 inclusion and 2 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 21 May 2024. 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 Pakistan. 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?
Blood glucose level (time frame: baseline to 30 minutes and 60 minutes). 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 21 May 2024.