跳至主要内容
临床试验/NCT06028399
NCT06028399Enrolling By Invitation不适用

Effects of Concurrent Training on Glycaemic & Vascular Parameters Among Patients With Type-II DM Associated Peripheral Artery Disease.

Ziauddin University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
80
试验地点
2
主要终点
Ankle Brachial Index (ABI) for peripheral artery disease

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
40 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Ankle Brachial Index (ABI) for peripheral artery disease

时间窗: 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).

HbA1c for glycemic control

时间窗: 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).

Functional Capacity for functional claudication distance

时间窗: 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

时间窗: 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)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Uroosa Amin

Student

Ziauddin University

研究点 (2)

Loading locations...

相似试验

Concurrent Training on Patients With Type-II DM... | 临床试验