Clinical trial NCT06461871: Combined Effects of BT With Moderate Intensity Aerobic Versus RT in Type 2 DM.
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: cardio respiratory fitness
aerobic exercise
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 46
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

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.

Detailed description: 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,

Eligibility criteria: 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)

Primary outcomes:
measure: VO2 MAX
timeFrame: 12 weeks
measure: EQ -5D-5L QUESTIONNAIRE
timeFrame: 12 weeks
measure: HbA1c
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Social Security Teaching Hospital Shah rah, Lahore.
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sidra Faisal, MS.CPPT
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.