Type 2 Diabetes With Peripheral AngiopathyNCT06028399
Concurrent Training on Patients With Type-II DM Associated PAD.
A study testing Concurrent Training and Aerobic Training in people with Type 2 Diabetes With Peripheral Angiopathy, run by Ziauddin University at 1 site in Pakistan.
Trial summary
This clinical trial aims to analyze the effects of concurrent vs aerobic training on glycemic control, ABI, functional capacity and disease-specific QOL among patients with Type-II DM-associated PAD at baseline \& after 12 weeks of intervention. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 40 to 50 years
- Conditions the study is for
- Type 2 Diabetes With Peripheral Angiopathy
- What is being tested?
- Concurrent Training and Aerobic Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2023to Nov 2023
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 40 - 50 years
- Type-II DM
- Duration of DM: > 10 years
- Baseline HbA1C (> 6.6%)
- Intermittent claudication corresponding to Fontaine Stage IIa
- PAD by an ABI scale; < 0.9 at rest
- Had < 160 mmHg SBP and < 105 mmHg DBP
- Sedentary lifestyle by IPAQ-SF
Who cannot join
- Smokers
- Insulin dependent individuals
- Patients with Complicated cardiovascular disease that might limit their ability to - participate in the intervention period physically (e.g. unstable cardiopulmonary symptoms, ischemic heart failure, or chronic kidney disease) and cancer
- Any major surgery or revascularization procedure within the previous 1 year
- In case of a history of severe arthritis that may limit exercise performance
- Diabetic foot (ulceration or gangrene)
Show all 11Show fewer
- Patients with stroke
- BMI = >30 classified by WHO-Asian as obesity class II
- Unable to follow the intervention protocol or visit three times per week for exercise
- Participation in any clinical trial during the past six months
- Revocation to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Concurrent Training on Glycaemic & Vascular Parameters Among Patients With Type-II DM Associated Peripheral Artery Disease.
This clinical trial aims to analyze the effects of concurrent vs aerobic training on glycemic control, ABI, functional capacity and disease-specific QOL among patients with Type-II DM-associated PAD at baseline \& after 12 weeks of intervention. The main questions it aims to answer are:
- Is concurrent training more effective than aerobic training in improving glycemic control among patients with Type-II DM-associated PAD?
- Is concurrent training more effective than aerobic training in improving ABI among patients with Type-II DM-associated PAD?
- Is concurrent training more effective than aerobic training in enhancing functional capacity among patients with Type-II DM-associated PAD?
- Is concurrent training more effective than aerobic training in improving QOL among patients with Type-II DM-associated PAD? Signed informed consent will be taken before participation. For exercise training, Both will perform Warm up for 10 - 12 minutes, followed by 30 - 60 minutes of training protocol and then Cool down exercises for 10 - 12 minutes. Group A will perform concurrent training, whereas Group B will perform aerobic training.
Read the detailed description
DATA COLLECTION PROCEDURE;
Eighty patients will be referred from the OPD of Dr. Ziauddin Hospital Karachi, Pakistan. Signed informed consent will be obtained before participation. In the screening session, PAD by Fontaine's stage IIa, ABI (<0.9), and an international Physical activity questionnaire (IPAQ) to assess sedentary behaviour will be collected. For IPAQ interpretation, <600 MET Minutes will be considered category 1 (Lowest level of physical activity). In the next session, baseline measurements of all participants will be collected and documented, including HbA1C, ABI at rest, Functional Capacity, and QOL.
Moreover, Target heart rate (THR) and 1RM will be calculated for appropriate exercise intensity and BMI. Further, All patients will be randomly allocated into two groups. Group A (n=40) will perform concurrent training, whereas Group B will perform aerobic training (n=40). All patients will receive a brief explanation and demonstration of the exercise session during the familiarisation. Patients will perform 3 sessions weekly to improve their capability to do exercises and develop the exercise capacity needed to begin at the intensity of their allocated training protocol. Both groups will perform warm-up exercises for 10 - 12 minutes during the training session, followed by training protocol and then cool-down exercises for 10 - 12 minutes. Group A will perform concurrent training for 30 to 60 minutes, whereas Group B will perform aerobic training for 30 - 60 minutes. Both groups will perform warm-up and cool-down exercises for 10 - 12 minutes, including 5 minutes of static cycling followed by 5 reps. of static stretching of the hamstring, quadriceps, and calf muscles on each limb with the 10-second hold of each stretch (ACSM, 2018). During the intervention period, patients will be assessed for Heart rate, blood pressure, and random blood sugar before and after each session for 12 weeks duration, and perceived exertion status will be used during exercise for analyzing the exercise intensity.
Group A (Concurrent Training):
Concurrent training combines aerobic and resistance training within the same session. Patients in this group will perform aerobic exercises and resistance training for 30 - 60 minutes, comprising 3 sessions per week for 12 weeks under the supervision of a physical therapist. Aerobic training will be performed on a treadmill at an intensity of 40 - 60 % THR for 15 - 40 minutes, followed by resistance training using an elastic resistance band at 60 - 80% of 1 RM, following appropriate rest intervals. The patient will perform lower limb resistance exercises, including Quadriceps extension, leg curls, calf raises \& toe raises.
Group B (Aerobic Training):
Patients in this group will perform aerobic exercise for 12 weeks. All Patients will be assessed for HR, BP and RBS before and after each session. Patients in this group will perform aerobic exercises for 30 - 60 minutes, comprising 3 sessions per week for 12 weeks under the supervision of a physical therapist. Aerobic training will be performed on a treadmill at an intensity of 40 - 60 % THR.
After 12 weeks of intervention, all patients will be assessed for HbA1C, ABI, functional capacity, and QOL and documented for further data analysis.
SPECIAL CONSIDERATION FOR EXERCISE
- Educate the patient about the signs and symptoms of hypoglycemia.
- Hypoglycemia manifestations (particularly tachycardia) may mask due to Β-Blockers.
- Blood glucose level monitoring (before and after exercise).
- Carbohydrate intake (up to 15 g before exercise participation) to prevent hypoglycemia *when starting RBS ≤100 mg/dL.
- Avoid head-down activities and the Valsalva manoeuvre.
- For peripheral neuropathy, closely examine feet regularly to detect sores or ulcers and incorporate proper foot care (dry feet, silica gel or air midsoles \& polyester socks).
EXERCISE TERMINATION CRITERIA The exercise will be terminated if the patient reports any following symptoms during exercise.
- The onset of Chest pain
- Shortness of breath (Borg's scale >15)
- Hemodynamic imbalance during exercise is caused by limited perfusion (Pale appearance, cool skin, Diaphoresis (sweating), Physical exertion, altered pulse) and Low blood pressure (very late sign)
- On the patient's request to stop exercise
- Ischemic limb pain that is not alleviated after 10 minutes
- Being tested
- Concurrent Training, Aerobic Training
- Keywords
- Concurrent Exercise Training, Physical Exercise, Glycated hemoglobin, Glycemic control, Insulin Resistance, Type 2 Diabetes Mellitus
- Medical subject headings
- Motor Activity, Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent TrainingOther
The patient in the Concurrent Training group will perform exercises for 30 - 60 minutes in 3 sessions per week for 12 weeks under the supervision of a physical therapist. Aerobic training will be performed on a treadmill at an intensity of 40 - 60 % THR for 15 - 40 minutes, followed by resistance training (Quadriceps extension, leg curls, calf raise \& toe raise) using an elastic resistance band at an intensity of 60 - 80% of 1 RM, following appropriate rest intervals.
Aerobic TrainingOther
The patient in the Aerobic Training group will perform exercises on a treadmill for 30 - 60 minutes in 3 sessions per week for 12 weeks under the supervision of a physical therapist. Aerobic training will be performed on a treadmill at an intensity of 40 - 60 % THR, following appropriate rest intervals.
| Study group | Role | What they receive |
|---|---|---|
| Concurrent Training | Experimental | Concurrent training combines aerobic and resistance training within the same session for 30 - 60 minutes, comprising 3 sessions per week for 12 weeks. Receives: Other: Concurrent Training |
| Aerobic Training | Active comparator | Aerobic training for 30 - 60 minutes comprises 3 sessions per week for 12 weeks. Receives: Other: Aerobic Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c for glycemic control
The hemoglobin A1C (HbA1c) is a gold standard for assessing glycemic control for 2-3 months (Chehregosha et al., 2019). HbA1C has excellent reliability and validity (Sn= 0.8, Sp=0.9, AUROC = 0.9) (Rathod et al., 2018).
Measured: 12 weeks
Ankle Brachial Index (ABI) for peripheral artery disease
ABI is a non-invasive method for determining the presence and severity of PAD, commonly used in clinical settings (Thurston and Dawson, 2019). Doppler ABI has 80.3% sensitivity and 78.1% specificity on the side with high pressures (Mayr et al., 2019). An ABI of 0.9 is considered diagnostic for PAD. Using a portable Doppler Ultrasound with a 5MHz probe, the systolic pressures of the right and left brachial, \& dorsalis pedis arteries will be assessed then higher systolic blood pressure will be considered for the study. The ABI will be calculated by dividing the brachial pressures by the lower extremity (Chen et al., 2021).
Measured: 12 weeks
Functional Capacity for functional claudication distance
The patient will walk on 100 feet indoor track, and distance will be measured on claudication symptoms when the patient prefers to stop walking, which will analyze pre and post-intervention to assess the effectiveness of therapeutic intervention (Sinnige et al., 2022). The reliability of FCD is 0.959. FCD is a reliable and valid measurement for determining functional capacity in patients with intermittent claudication (Bubb et al., 2021, Abola et al., 2020).
Measured: 12 weeks
Quality of life for disease-specific patient reported outcomes
The Vasculo-6 questionnaire evaluates disease-specific QOL among patients with symptomatic PAD. Each question is scored out of four, of which one is the lowest score, and four will be the highest. The sum of all components yields the final score. The final score could range between 6-24 points. VQ-6 has strong reliability (Cronbach=0.82), validity (AUC=0.754) \& excellent receptivity to change after intervention (standard response means=1.12)
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 posted8 Sep 2023
- Study start15 Jul 2023
- Primary completionOct 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes With Peripheral AngiopathyStudies of the same condition, open and under way.
- 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
- Model description
- In this randomized controlled trial, there are 2 parallel groups. Group A for Concurrent training and Group B for Aerobic training.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uroosa Amin, Ziauddin University
- Investigators
- Uroosa Amin, DPT, Principal investigator, Ziauddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028399
- Sponsor's protocol ID
- 7170523HSPAT
- Status last verified
- Sep 2023
- First submitted
- 30 Aug 2023
- Last updated
- 8 Sep 2023
- 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 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Concurrent Training on Glycaemic & Vascular Parameters Among Patients With Type-II DM Associated Peripheral Artery Disease.
- ClinicalTrials.gov ID
- NCT06028399
- Acronym / sponsor ID
- 7170523HSPAT
- Keywords
- Concurrent Exercise Training, Physical Exercise, Glycated hemoglobin, Glycemic control, Insulin Resistance, Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 8 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.
This clinical trial aims to analyze the effects of concurrent vs aerobic training on glycemic control, ABI, functional capacity and disease-specific QOL among patients with Type-II DM-associated PAD at baseline \& after 12 weeks of intervention. The main questions it aims to answer are:
- Is concurrent training more effective than aerobic training in improving glycemic control among patients with Type-II DM-associated PAD?
- Is concurrent training more effective than aerobic training in improving ABI among patients with Type-II DM-associated PAD?
- Is concurrent training more effective than aerobic training in enhancing functional capacity among patients with Type-II DM-associated PAD?
- Is concurrent training more effective than aerobic training in improving QOL among patients with Type-II DM-associated PAD? Signed informed consent will be taken before participation. For exercise training, Both will perform Warm up for 10 - 12 minutes, followed by 30 - 60 minutes of training protocol and then Cool down exercises for 10 - 12 minutes. Group A will perform concurrent training, whereas Group B will perform aerobic training.
Detailed description
DATA COLLECTION PROCEDURE;
Eighty patients will be referred from the OPD of Dr. Ziauddin Hospital Karachi, Pakistan. Signed informed consent will be obtained before participation. In the screening session, PAD by Fontaine's stage IIa, ABI (<0.9), and an international Physical activity questionnaire (IPAQ) to assess sedentary behaviour will be collected. For IPAQ interpretation, <600 MET Minutes will be considered category 1 (Lowest level of physical activity). In the next session, baseline measurements of all participants will be collected and documented, including HbA1C, ABI at rest, Functional Capacity, and QOL.
Moreover, Target heart rate (THR) and 1RM will be calculated for appropriate exercise intensity and BMI. Further, All patients will be randomly allocated into two groups. Group A (n=40) will perform concurrent training, whereas Group B will perform aerobic training (n=40). All patients will receive a brief explanation and demonstration of the exercise session during the familiarisation. Patients will perform 3 sessions weekly to improve their capability to do exercises and develop the exercise capacity needed to begin at the intensity of their allocated training protocol. Both groups will perform warm-up exercises for 10 - 12 minutes during the training session, followed by training protocol and then cool-down exercises for 10 - 12 minutes. Group A will perform concurrent training for 30 to 60 minutes, whereas Group B will perform aerobic training for 30 - 60 minutes. Both groups will perform warm-up and cool-down exercises for 10 - 12 minutes, including 5 minutes of static cycling followed by 5 reps. of static stretching of the hamstring, quadriceps, and calf muscles on each limb with the 10-second hold of each stretch (ACSM, 2018). During the intervention period, patients will be assessed for Heart rate, blood pressure, and random blood sugar before and after each session for 12 weeks duration, and perceived exertion status will be used during exercise for analyzing the exercise intensity.
Group A (Concurrent Training):
Concurrent training combines aerobic and resistance training within the same session. Patients in this group will perform aerobic exercises and resistance training for 30 - 60 minutes, comprising 3 sessions per week for 12 weeks under the supervision of a physical therapist. Aerobic training will be performed on a treadmill at an intensity of 40 - 60 % THR for 15 - 40 minutes, followed by resistance training using an elastic resistance band at 60 - 80% of 1 RM, following appropriate rest intervals. The patient will perform lower limb resistance exercises, including Quadriceps extension, leg curls, calf raises \& toe raises.
Group B (Aerobic Training):
Patients in this group will perform aerobic exercise for 12 weeks. All Patients will be assessed for HR, BP and RBS before and after each session. Patients in this group will perform aerobic exercises for 30 - 60 minutes, comprising 3 sessions per week for 12 weeks under the supervision of a physical therapist. Aerobic training will be performed on a treadmill at an intensity of 40 - 60 % THR.
After 12 weeks of intervention, all patients will be assessed for HbA1C, ABI, functional capacity, and QOL and documented for further data analysis.
SPECIAL CONSIDERATION FOR EXERCISE
- Educate the patient about the signs and symptoms of hypoglycemia.
- Hypoglycemia manifestations (particularly tachycardia) may mask due to Β-Blockers.
- Blood glucose level monitoring (before and after exercise).
- Carbohydrate intake (up to 15 g before exercise participation) to prevent hypoglycemia *when starting RBS ≤100 mg/dL.
- Avoid head-down activities and the Valsalva manoeuvre.
- For peripheral neuropathy, closely examine feet regularly to detect sores or ulcers and incorporate proper foot care (dry feet, silica gel or air midsoles \& polyester socks).
EXERCISE TERMINATION CRITERIA The exercise will be terminated if the patient reports any following symptoms during exercise.
- The onset of Chest pain
- Shortness of breath (Borg's scale >15)
- Hemodynamic imbalance during exercise is caused by limited perfusion (Pale appearance, cool skin, Diaphoresis (sweating), Physical exertion, altered pulse) and Low blood pressure (very late sign)
- On the patient's request to stop exercise
- Ischemic limb pain that is not alleviated after 10 minutes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- In this randomized controlled trial, there are 2 parallel groups. Group A for Concurrent training and Group B for Aerobic training.
| Arm | Type | Receives |
|---|---|---|
| Concurrent Training | Experimental | Other: Concurrent TrainingConcurrent training combines aerobic and resistance training within the same session for 30 - 60 minutes, comprising 3 sessions per week for 12 weeks. |
| Aerobic Training | Active comparator | Other: Aerobic TrainingAerobic training for 30 - 60 minutes comprises 3 sessions per week for 12 weeks. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age: 40 - 50 years
- Type-II DM
- Duration of DM: > 10 years
- Baseline HbA1C (> 6.6%)
- Intermittent claudication corresponding to Fontaine Stage IIa
Key exclusion criteria (11 listed)
- Smokers
- Insulin dependent individuals
- Patients with Complicated cardiovascular disease that might limit their ability to - participate in the intervention period physically (e.g. unstable cardiopulmonary symptoms, ischemic heart failure, or chronic kidney disease) and cancer
- Any major surgery or revascularization procedure within the previous 1 year
- In case of a history of severe arthritis that may limit exercise performance
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 |
|---|---|---|
| Concurrent TrainingThe patient in the Concurrent Training group will perform exercises for 30 - 60 minutes in 3 sessions per week for 12 weeks under the supervision of a physical therapist. Aerobic training will be performed on a treadmill at an intensity of 40 - 60 % THR for 15 - 40 minutes, followed by resistance training (Quadriceps extension, leg curls, calf raise \& toe raise) using an elastic resistance band at an intensity of 60 - 80% of 1 RM, following appropriate rest intervals. | Other | Concurrent Training |
| Aerobic TrainingThe patient in the Aerobic Training group will perform exercises on a treadmill for 30 - 60 minutes in 3 sessions per week for 12 weeks under the supervision of a physical therapist. Aerobic training will be performed on a treadmill at an intensity of 40 - 60 % THR, following appropriate rest intervals. | Other | Aerobic Training |
Primary outcome
HbA1c for glycemic control
Time frame: 12 weeks
The hemoglobin A1C (HbA1c) is a gold standard for assessing glycemic control for 2-3 months (Chehregosha et al., 2019). HbA1C has excellent reliability and validity (Sn= 0.8, Sp=0.9, AUROC = 0.9) (Rathod et al., 2018).
Ankle Brachial Index (ABI) for peripheral artery disease
Time frame: 12 weeks
ABI is a non-invasive method for determining the presence and severity of PAD, commonly used in clinical settings (Thurston and Dawson, 2019). Doppler ABI has 80.3% sensitivity and 78.1% specificity on the side with high pressures (Mayr et al., 2019). An ABI of 0.9 is considered diagnostic for PAD. Using a portable Doppler Ultrasound with a 5MHz probe, the systolic pressures of the right and left brachial, \& dorsalis pedis arteries will be assessed then higher systolic blood pressure will be considered for the study. The ABI will be calculated by dividing the brachial pressures by the lower extremity (Chen et al., 2021).
Functional Capacity for functional claudication distance
Time frame: 12 weeks
The patient will walk on 100 feet indoor track, and distance will be measured on claudication symptoms when the patient prefers to stop walking, which will analyze pre and post-intervention to assess the effectiveness of therapeutic intervention (Sinnige et al., 2022). The reliability of FCD is 0.959. FCD is a reliable and valid measurement for determining functional capacity in patients with intermittent claudication (Bubb et al., 2021, Abola et al., 2020).
Quality of life for disease-specific patient reported outcomes
Time frame: 12 weeks
The Vasculo-6 questionnaire evaluates disease-specific QOL among patients with symptomatic PAD. Each question is scored out of four, of which one is the lowest score, and four will be the highest. The sum of all components yields the final score. The final score could range between 6-24 points. VQ-6 has strong reliability (Cronbach=0.82), validity (AUC=0.754) \& excellent receptivity to change after intervention (standard response means=1.12)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: No
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.
Uroosa Amin, DPT principal investigator
Ziauddin 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 Concurrent Training and Aerobic Training in people with Type 2 Diabetes With Peripheral Angiopathy, run by Ziauddin 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 8 inclusion and 11 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 8 Sep 2023. 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?
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?
HbA1c for glycemic control (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 8 Sep 2023; AzTrials last refreshed its copy on 31 Oct 2026.