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

NCT ID: NCT06461871

Last Updated: 2024-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-10

Study Completion Date

2023-11-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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,

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

moderate intensity aerobic exercises with balance training

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

Group Type EXPERIMENTAL

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

Intervention Type 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

Moderate intensity resistance exercises in combination with balance training

Intervention Type 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 resistance exercises with balance training

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

Group Type EXPERIMENTAL

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

Intervention Type 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

Moderate intensity resistance exercises in combination with balance training

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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

Intervention Type OTHER

Moderate intensity resistance exercises in combination with balance training

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Moderate intensity aerobic exercises in combination with balance training

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sidra Faisal, MS.CPPT

Role: STUDY_CHAIR

Riphah International University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Social Security Teaching Hospital Shah rah, Lahore.

Lahore, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 36897872 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31632002 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC/RCR & AHS/23/0337

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.