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Completed

NCT Number: NCT06461871

Combined Effects of BT With Moderate Intensity Aerobic Versus RT in Type 2 DM.

A randomized control trail will be conducted at Social Security Teaching Hospital, Multan Road, Lahore. Social Security Teaching Hospital Shah rah, Lahore. Non -probability Convenient Random Sampling Technique will be applied on patients who will be allocated through simple random sampling into group A and group B. Group A received moderate intensity aerobic exercises which include walking, cycling, with each session lasting 15 minutes for 3-5 days per week in combination with balance training which include heel raise, standing march with 10 repetitions each for 3-5 days per week. Group B receive moderate intensity resistance exercises which include biceps curls, triceps curls , with each session lasting 10 repetitions for 3-5 days per week in combination with balance training which include heel raise, standing march with 10 repetitions each for 3-5 days per week. The study will be completed with time duration of six months .Primary outcome of research will be glycemic control, cardio respiratory fitness, and quality of life. Data will be analyzed using SPSS software version 21. After assessing normality of Shapiro-will test, it will be decided either parametric or non parametric test will be used within a group or between groups.

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Social Security Teaching Hospital Shah rah, Lahore.

Lahore, Punjab Province, 54000, Pakistan

About this study

Exercise is often authorize for type 2 diabetic patients in command to intensify their physical activity, physical fitness, and glycolic management . More than 95 of individuals with diabetes have type 2 diabetes millets (DM), which is initiated by body inappropriate utilization of insulin .Type 2 diabetes has been associated to sedentary habits, smoking, immoderate alcohol use, extreme glucose intake, among other lifestyle representative. Diabetic neuropathy is frequent complication of type 2 diabetes millets with a considerable effect on health of influenced individuals .The existence of diabetic neuropathy may impair balance in affected patients. Type 2 diabetes millets can remarkably lesser person's quality of life, with health related quality of life constitute the main concern.

A randomized control trail will be conducted at Social Security Teaching Hospital, Multan Road, Lahore. Social Security Teaching Hospital Shah rah, Lahore. Non -probability Convenient Random Sampling Technique will be applied on patients who will be allocated through simple random sampling into group A and group B. Group A received moderate intensity aerobic exercises which include walking, cycling, with each session lasting 15 minutes for 3-5 days per week in combination with balance training (BT) which include heel raise, standing march with 10 repetitions each for 3-5 days per week. Group B receive moderate intensity resistance exercises which include biceps curls, triceps curls , with each session lasting 10 repetitions for 3-5 days per week in combination with balance training which include heel raise, standing march with 10 repetitions each for 3-5 days per week. The study will be completed with time duration of six months .Primary outcome of research will be glycemic control, cardio respiratory fitness, and quality of life. Data will be analyzed using SPSS software version 21. After assessing normality of Shapiro-will test, it will be decided either parametric or non parametric test will be used within a group or between groups.

Key words:

Type 2 diabetes millets, cardio respiratory fitness, glycemic control, aerobic exercise, resisted exercise,

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with 40-60 years of age with type 2 diabetes mellitus.(16)
  • Both male and female participants are included in study.(17)
  • Participants with HbA1c level greater than >6.4(18)
  • Patients with diabetic neuropathy (19)
  • Without participation in any supervised exercise program in last 6 months(19, 20)
  • Dietary pattern stabilized for at least 6 months(8)

Exclusion criteria

  • Participants with mental impairments .(21, 22)
  • Those with gout or hyperuricemia. (16, 22, 23)
  • Patient with serious cardiovascular risk factors (24, 25)
  • Pregnant females (26, 27)
  • Participants with hepatic and renal impairment.(22)

Treatment and study plan

BALANCE TRAINING WITH MODERATE INTESITY AEROBIC VERSUS RESISTED TRAINING (RT)

Other

The duration of study is 6 months. Three to five sessions of both aerobic and resistance exercise training in combination with balance training are taken out per week . Each session lasting 15 minutes. GROUP A: Baseline treatment + Moderate intensity aerobic exercises in combination with balance training

Other names: Moderate intensity aerobic exercises in combination with balance training

Moderate intensity resistance exercises in combination with balance training

Other

The duration of study is 6 months. Three to five sessions of both aerobic and resistance exercise training in combination with balance training are taken out per week . Each session lasting 15 minutes. GROUP B: Baseline treatment + Moderate intensity resistance exercises in combination with balance training

Primary outcomes

  1. VO2 MAX

    Time frame: 12 weeks

    To assess cardiorespiratory fitness , also known as maximal oxygen uptake , measures maximum amount of oxygen a person can utilize oxygen.

    VO2 max = 132.853 - (0.0769 x your weight in pounds) - (0.3877 x your age) + (6.315 if you are male or 0 if you are female) - (3.2649 x your walking time) - (0.1565 x your heart rate at the end of the test).

  2. EQ -5D-5L QUESTIONNAIRE

    Time frame: 12 weeks

    EQ-5D-5L is a self assessed , health related, quality of life questionnaire. The scale measures quality of life on a 5 component scale including mobility, self care, usual activities, pain/discomfort , anxiety /depression .

  3. HbA1c

    Time frame: 12 weeks

    Hemoglobin analyzers (also referred to as HbA1c Analyzer) can report the concentration of hemoglobin in a blood or urine sample in g/L, g/dL, or mol/L. HbA1c Analyzers can run tests with samples as small as 1uL in just a few minutes.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Combined Effects of Balance Training With Moderate Intensity Aerobic Versus Resisted Training on Glycemic Control, Cardiorespiratory Fitness , and Quality of Life in Patients With Type 2 Diabetes Milletus.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 17, 2024
Registry last updated
Jun 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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