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

NCT06461871 | Completed DMC

• 1 other identifier: REC/RCR & AHS/23/0337
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

cardio respiratory fitness; aerobic exercise

Outcome Measures

Primary Outcomes (3)

• VO2 MAX

  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).

  12 weeks

• EQ -5D-5L QUESTIONNAIRE

  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 .

  12 weeks

• HbA1c

  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.

  12 weeks

Study Arms (2)

moderate intensity aerobic exercises with balance training

EXPERIMENTAL

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

Other: BALANCE TRAINING WITH MODERATE INTESITY AEROBIC VERSUS RESISTED TRAINING (RT); Other: Moderate intensity resistance exercises in combination with balance training

moderate intensity resistance exercises with balance training

EXPERIMENTAL

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

Other: BALANCE TRAINING WITH MODERATE INTESITY AEROBIC VERSUS RESISTED TRAINING (RT); Other: Moderate intensity resistance exercises in combination with balance training

Interventions

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

Also known as: Moderate intensity aerobic exercises in combination with balance training

moderate intensity aerobic exercises with balance training; moderate intensity resistance exercises 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

moderate intensity aerobic exercises with balance training; moderate intensity resistance exercises with balance training

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Social Security Teaching Hospital Shah rah, Lahore.

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (2)

• Dawite F, Girma M, Shibiru T, Kefelew E, Hailu T, Temesgen R, Abebe G. Factors associated with poor glycemic control among adult patients with type 2 diabetes mellitus in Gamo and Gofa zone public hospitals, Southern Ethiopia: A case-control study. PLoS One. 2023 Mar 10;18(3):e0276678. doi: 10.1371/journal.pone.0276678. eCollection 2023.

  PMID: 36897872 BACKGROUND

• Lim JU, Park CK, Kim TH, Jang AS, Park YB, Rhee CK, Jung KS, Yoo KH, Lee WY, Yoon HK. The Difficulty Of Improving Quality Of Life In COPD Patients With Depression And Associated Factors. Int J Chron Obstruct Pulmon Dis. 2019 Oct 9;14:2331-2341. doi: 10.2147/COPD.S216746. eCollection 2019.

  PMID: 31632002 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Sidra Faisal, MS.CPPT

  Riphah International University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: June 10, 2023
• Primary Completion: August 10, 2023
• Study Completion: November 20, 2023
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)