Type II Diabetes MellitusNCT06387550
Effects of Eccentric Training on Glycemic Control and Quality of Life in Patients With Type II Diabetes Mellitus
A study testing Eccentric Training in people with Type II Diabetes Mellitus, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Diabetes is defined by the level of hyperglycemia its a metabolic chronic disorder that furthur lead to life threatning medical conditions however, the prevalence of diabetes is rapidly increasing day by day in both developed and developing countries making it global pandemic and type II is more prevalent. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- Eccentric Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2024to 15 Jul 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both gender
- Blood pressure should be <140/90mm of Hg
- Diagnosed Diabetic patient (HBA1C>6.4%)
- Adults (Age 40 +) from Rawalpindi and Islamabad
Who cannot join
- Acute infection
- History of recent trauma
- Acute coronary syndrome
- Peripheral vascular diseases
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
Zara Khalid, PhD*, +923335415822, zara.khalid@fui.edu.pk
About this study
Diabetes is defined by the level of hyperglycemia its a metabolic chronic disorder that furthur lead to life threatning medical conditions however, the prevalence of diabetes is rapidly increasing day by day in both developed and developing countries making it global pandemic and type II is more prevalent. Life dependency is increased due to long term effects of diabetes in specifically older individuals. Physical activity and exercise improves glucose tolerance and also reduces other life threatening diabetic complications, improving the quality of life in diabetic population.
Read the detailed description
Diabetes is a metabolic chronic disorder and its becoming a global pandemic and its prevalence rises quickly in both developed and developing countries.Diabetes confirmation is done through levels of hyperglycemia. According to American Diabetic Association level of HBA1C is greater than 6.4
% indicate presence of diabetes.Type II is more prevalent and its deteriorting effect on body with increasing age are more pronounced.Insuline resistance and impaired glucose tolerance are seen in type II diabetes mellitus patients.
Studies depict that regular exercise improve glycemic control and improve insuline sensitivity and enhance glucose uptake by muscles.
Strength training enhance quality of life and protect your joints from injury. Previous studies have specified the impact of several types of training on older adults, young healthy adults and diabetic patients but there is limited literature found in terms of solely observing the effect of eccentric training on glycemic control and quality of life in diabetic patient.
Current study was designed to determine the effects of eccentric training on glycemic control and quality of life in type II diabetes Mellitus.
- Conditions
- Type II Diabetes Mellitus
- Being tested
- Eccentric Training
- Keywords
- Eccentric training, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric TrainingProcedure or surgery
Warm up phase that include hip circles and shoulder rolls(1 sets of 5 reps), participants are trained on bicycle ergometer for 15 minutes on 2-3 times a week and its duration is increased according to patient tolerance, after that they will be pass through exercise phase that include squating, lunges and leg press (8-10 reps of 3 sets) after that cool down phase begin that include cat cow stretch and oblique stretch (5 reps of 1 set)
| Study group | Role | What they receive |
|---|---|---|
| Eccentric Training Group | Experimental | Patients in this group firstly passing through warm up phase that include hip circles and shoulder rolls(1 sets of 5 reps), participants are trained on bicycle ergometer for 15 minutes on 2-3 times a week and its duration is increased according to patient tolerance, after that they will be pass through exercise phase that include squating, lunges and leg press (8-10 reps of 3 sets) after that cool down phase begin that include cat cow stretch and oblique stretch (5 reps of 1 set) Receives: Procedure: Eccentric Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Lab investigation of glycemic control will be through HBA1C test.
Measured: 8 weeks
Patient's quality of life
Quality of life will be assessed using EQ5DL Questionnaire.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start20 Mar 2024
- Primary completion1 Jul 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pre-post quasi experimental study having one group analysis.Participants will be selected through inclusion and exclusion criteria then pre assessment would be done that include HBA1C and EQ5DL QOL tool, followed by intervention and post assessment.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387550
- Sponsor's protocol ID
- FUI/CTR/2024/3
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Eccentric Training on Glycemic Control and Quality of Life in Patients With Type II Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06387550
- Acronym / sponsor ID
- FUI/CTR/2024/3
- Conditions
- Type II Diabetes Mellitus
- Keywords
- Eccentric training, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 29 Apr 2024 (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.
Diabetes is defined by the level of hyperglycemia its a metabolic chronic disorder that furthur lead to life threatning medical conditions however, the prevalence of diabetes is rapidly increasing day by day in both developed and developing countries making it global pandemic and type II is more prevalent. Life dependency is increased due to long term effects of diabetes in specifically older individuals. Physical activity and exercise improves glucose tolerance and also reduces other life threatening diabetic complications, improving the quality of life in diabetic population.
Detailed description
Diabetes is a metabolic chronic disorder and its becoming a global pandemic and its prevalence rises quickly in both developed and developing countries.Diabetes confirmation is done through levels of hyperglycemia. According to American Diabetic Association level of HBA1C is greater than 6.4
% indicate presence of diabetes.Type II is more prevalent and its deteriorting effect on body with increasing age are more pronounced.Insuline resistance and impaired glucose tolerance are seen in type II diabetes mellitus patients.
Studies depict that regular exercise improve glycemic control and improve insuline sensitivity and enhance glucose uptake by muscles.
Strength training enhance quality of life and protect your joints from injury. Previous studies have specified the impact of several types of training on older adults, young healthy adults and diabetic patients but there is limited literature found in terms of solely observing the effect of eccentric training on glycemic control and quality of life in diabetic patient.
Current study was designed to determine the effects of eccentric training on glycemic control and quality of life in type II diabetes Mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pre-post quasi experimental study having one group analysis.Participants will be selected through inclusion and exclusion criteria then pre assessment would be done that include HBA1C and EQ5DL QOL tool, followed by intervention and post assessment.
| Arm | Type | Receives |
|---|---|---|
| Eccentric Training Group | Experimental | Procedure: Eccentric TrainingPatients in this group firstly passing through warm up phase that include hip circles and shoulder rolls(1 sets of 5 reps), participants are trained on bicycle ergometer for 15 minutes on 2-3 times a week and its duration is increased according to patient tolerance, after that they will be pass through exercise phase that include squating, lunges and leg press (8-10 reps of 3 sets) after that cool down phase begin that include cat cow stretch and oblique stretch (5 reps of 1 set) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both gender
- Blood pressure should be <140/90mm of Hg
- Diagnosed Diabetic patient (HBA1C>6.4%)
- Adults (Age 40 +) from Rawalpindi and Islamabad
Key exclusion criteria (4 listed)
- Acute infection
- History of recent trauma
- Acute coronary syndrome
- Peripheral vascular diseases
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 |
|---|---|---|
| Eccentric TrainingWarm up phase that include hip circles and shoulder rolls(1 sets of 5 reps), participants are trained on bicycle ergometer for 15 minutes on 2-3 times a week and its duration is increased according to patient tolerance, after that they will be pass through exercise phase that include squating, lunges and leg press (8-10 reps of 3 sets) after that cool down phase begin that include cat cow stretch and oblique stretch (5 reps of 1 set) | Procedure or surgery | Eccentric Training Group |
Primary outcome
Glycemic control
Time frame: 8 weeks
Lab investigation of glycemic control will be through HBA1C test.
Patient's quality of life
Time frame: 8 weeks
Quality of life will be assessed using EQ5DL Questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric Training in people with Type II Diabetes Mellitus, run by Foundation University Islamabad 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 4 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: status not confirmed, as of the sponsor's last update on 29 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hajab Zehra, MS-MSKPT* (+923165089308, hajabzehra765@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: 8 weeks). The study lists 2 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 29 Apr 2024.