Diabetes Mellitus, Type 2NCT06461871
Combined Effects of BT With Moderate Intensity Aerobic Versus RT in Type 2 DM.
A study testing BALANCE TRAINING WITH MODERATE INTESITY AEROBIC VERSUS RESISTED TRAINING (RT) and Moderate intensity resistance exercises in combination with balance training in people with Diabetes Mellitus, Type 2, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- BALANCE TRAINING WITH MODERATE INTESITY AEROBIC VERSUS RESISTED TRAINING (RT) and Moderate intensity resistance exercises in combination with balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jun 2023to 20 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Social Security Teaching Hospital Shah rah, Lahore.
Lahore, Punjab Province, 54000
About this study
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.
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.
Read the 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,
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- BALANCE TRAINING WITH MODERATE INTESITY AEROBIC VERSUS RESISTED TRAINING (RT), Moderate intensity resistance exercises in combination with balance training
- Keywords
- cardio respiratory fitness, aerobic exercise
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BALANCE TRAINING WITH MODERATE INTESITY AEROBIC VERSUS RESISTED TRAINING (RT)Other
Also called Moderate intensity aerobic 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 A: Baseline treatment + Moderate intensity aerobic exercises in combination with balance training
Moderate intensity resistance exercises in combination with balance trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: BALANCE TRAINING WITH MODERATE INTESITY AEROBIC VERSUS RESISTED TRAINING (RT); Other: Moderate intensity resistance exercises in combination with balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 .
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start10 Jun 2023
- Primary completion10 Aug 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Faisal, MS.CPPT, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461871
- Sponsor's protocol ID
- REC/RCR & AHS/23/0337
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36897872Lim 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.
PubMed 31632002
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06461871
- Acronym / sponsor ID
- REC/RCR & AHS/23/0337
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- cardio respiratory fitness, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| moderate intensity aerobic exercises with balance training | Experimental | Other: BALANCE TRAINING WITH MODERATE INTESITY AEROBIC VERSUS RESISTED TRAINING (RT), Other: Moderate intensity resistance exercises in combination with balance trainingA 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 |
| moderate intensity resistance exercises with balance training | Experimental | Other: BALANCE TRAINING WITH MODERATE INTESITY AEROBIC VERSUS RESISTED TRAINING (RT), Other: Moderate intensity resistance exercises in combination with balance trainingGroup 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 |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BALANCE TRAINING WITH MODERATE INTESITY AEROBIC VERSUS RESISTED TRAINING (RT)Also: Moderate intensity aerobic exercises in combination with balance trainingThe 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 | moderate intensity aerobic exercises with balance training, moderate intensity resistance exercises with balance training |
| Moderate intensity resistance exercises in combination with balance trainingThe 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 | Other | moderate intensity aerobic exercises with balance training, moderate intensity resistance exercises with balance training |
Primary outcome
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).
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 .
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Background: PubMed 36897872Dawite 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.
- Background: PubMed 31632002Lim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sidra Faisal, MS.CPPT study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BALANCE TRAINING WITH MODERATE INTESITY AEROBIC VERSUS RESISTED TRAINING (RT) and Moderate intensity resistance exercises in combination with balance training in people with Diabetes Mellitus, Type 2, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 MAX (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06461871, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.