Concurrent Training on Patients With Type-II DM Associated PAD.

NCT06028399 | Unknown

• 1 other identifier: 7170523HSPAT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is concurrent training more effective than aerobic training in improving glycemic control among patients with Type-II DM-associated PAD?
2. 2.Is concurrent training more effective than aerobic training in improving ABI among patients with Type-II DM-associated PAD?
3. 3.Is concurrent training more effective than aerobic training in enhancing functional capacity among patients with Type-II DM-associated PAD?
4. 4.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.

Conditions

Type 2 Diabetes With Peripheral Angiopathy

Keywords

Concurrent Exercise Training; Physical Exercise; Glycated hemoglobin; Glycemic control; Insulin Resistance; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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).

  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)

  12 weeks

Study Arms (2)

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.

Other: Concurrent Training

Aerobic Training

ACTIVE COMPARATOR

Aerobic training for 30 - 60 minutes comprises 3 sessions per week for 12 weeks.

Other: Aerobic Training

Interventions

Concurrent Training OTHER

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.

Concurrent Training

Aerobic Training OTHER

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.

Aerobic Training

Eligibility Criteria

• Age: 40 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Ziauddin University: lead

Study Sites (1)

Uroosa Amin

Karachi, Sindh, 74700, Pakistan

Location

MeSH Terms

Conditions

Motor Activity; Insulin Resistance; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Behavior; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Uroosa Amin, DPT

  Ziauddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be allocated to the intervention group by using sealed envelop methods of simple random sampling. They were masked for the treatment allocation group. For assessment of outcome measures, HbA1C will be assessed by lab investigator, ABI and Functioncal capacity will be assessed by the physiotherapist who will be supervised the session.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Model Details: In this randomized controlled trial, there are 2 parallel groups. Group A for Concurrent training and Group B for Aerobic training.

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 8, 2023
• Study Start: July 15, 2023
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)