- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07484672
Comparative Effects of Periodized Circuit Training and Conventional Strength Training in Patients With Diabetes Type II
Comparative Effects of Periodized Circuit Training And Conventional Strength Training on Cardiovascular Fitness, Pulmonary Functions, Health- Related Quality of Life and Glycemic Control in Patients With Diabetes Type II
Patients with type II diabetes are at high risk of developing cardiovascular diseases due to increased blood sugar, inflammation, insulin resistance, and physical inactivity. The effectiveness of exercises in improving cardiopulmonary fitness have not been well documented and practiced in Pakistan. The objective of this study is to determine the comparative effects of Periodized circuit and strength training in improving cardiovascular fitness, pulmonary functions , quality of life and glycemic control in type II diabetes patients. The study will be a randomized clinical trial. Based on the inclusion and exclusion criteria participants will be divided into 2 groups, Group A and Group B. The study will be 6 weeks, 3 sessions per week (18 sessions). Group A will be asked to perform Periodized circuit training 45 min per session (20 min aerobic exercise with 10 min warm up and cool down) with moderate intensity, 10min break and 15 min of resistance exercise while Group B will follow Conventional strength training 45 min per session, 35 min of strength and endurance training with 10 min of warm up and cool down. The study outcomes measures will be pulmonary functions (FEV1. FVC, FEV1/FVC ratio) through digital spirometer quality of life through health-related quality of life (HRQOL) questionnaire , cardiopulmonary fitness ( heart rate, blood pressure, oxygen saturation through 6MWT) and Glycemic control through (BCM). The data will be assessed at baseline, daily after the interventions and end of the study. Data will be analyzed using IBM SPSS software version 23.
Key words: CT (Circuit training), CF (Cardiovascular fitness), PF (Pulmonary function), CST (Conventional strength training), CVD (cardiovascular disease), T2D (Type 2 diabetes), BCM (Blood Glucose Monitor)
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sindh
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Karachi, Sindh, Pakistan, 75510
- JPMC Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both gender age between 40 to 70
- Participants who are hemodynamically stable
- Participants who don't have any orthopedic limitation and can perform test
- Diagnosed diabetes type II for at least one year
- HBA1C less than 10% insulin independent
- Without limitations in gait or balance, Independent living in the community
- Non-smokers
Exclusion Criteria:
- Patients with any neurological or other systemic disease
- Individuals who are already performing physical activity such as muscle strengthening exercises, aerobic training, yoga or Pilates in last 6 months.
- Uncontrolled blood pressure
- Pregnancy or lactation
- Severe cardiac disease
- Patients who went under surgery for cardiac condition.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
Periodized Circuit Training
|
Group A: Periodized Circuit Training Protocol The participants in this group performed Periodized circuit training 45 min per session, 10 min break.
Before start exercises patients performed 5 min warm up session then 20 min of aerobic exercise and 15 min of resistance exercise.
The exercise session were, Walking, jogging, body weight, scissor exercise and lastly cool down session of 5 minutes
|
|
Experimental: Group B
Conventional Strength Training
|
The participants in this group performed Conventional strength training 45 min per session, 10 min break.
Before start exercises patients performed 5 min warm up session then 30 min of strength and endurance training.
The exercise session were jogging or walking, Glute Bridge, prone back extension, and ankle planter flexion and lastly cool down session of 5 min.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiovascular Fitness
Time Frame: 6 weeks
|
A 6-minute walk distance (6-MWD) in meters were performed to determine the cardiovascular fitness pre-post exercise
|
6 weeks
|
|
Pulmonary Functions
Time Frame: 6 weeks
|
Digital Spirometer is a common tool used to test pulmonary functions through measuring the volume of air a person can inhale and exhale, as well as how quickly they can do so.
It helps in diagnosing and monitoring respiratory diseases, and other conditions that affect lung function.
The reliability is usually good with test results reproducibility generally being above 90%.
The validity is also well-defined since spirometry is rated as gold standard of measuring the lung functioning.
FEV1, FVC, and FEV1/FVC ratio were measured pre-post exercise through digital spirometer
|
6 weeks
|
|
HRQoL
Time Frame: 6 weeks
|
HRQoL questionnaire were used to access quality of life of diabetes II patients pre-post exercise
|
6 weeks
|
|
Glycemic Control
Time Frame: 6 weeks
|
Blood glucose monitor device were used to check the glucose level, pre-post exercise
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hafiza Muiam Ghani, MSCPPT, Riphah International University
Publications and helpful links
General Publications
- Castro-Rodríguez M, Carnicero JA, Garcia-Garcia FJ, Walter S, Morley JE, Rodríguez-Artalejo F, et al. Frailty as a major factor in the increased risk of death and disability in older people with diabetes. Journal of the American Medical Directors Association. 2016;17(10):949-55.
- Fleck SJ. Periodized strength training: a critical review. The Journal of Strength & Conditioning Research. 1999;13(1):82-9.
- Ikenna UC, Ngozichi OG, Ijeoma I, Ijeoma N, Ifeanyichukwu N, Martin OC. Effect of circuit training on the cardiovascular endurance and quality of life: Findings from an apparently healthy female adult population. Journal of Applied Life Sciences International. 2020;23(3.1-8).
- Kraemer W. Fundamentals of resistance training: progression and exercise prescription. Medicine & science in sports & exercise. 2004.
- Suetta C, Andersen JL, Dalgas U, Berget J, Koskinen S, Aagaard P, et al. Resistance training induces qualitative changes in muscle morphology, muscle architecture, and muscle function in elderly postoperative patients. Journal of applied physiology. 2008;105(1):180-6.
- Lee I-M, Shiroma EJ, Lobelo F, Puska P, Blair SN, Katzmarzyk PT. Effect of physical inactivity on major non-communicable diseases worldwide: an analysis of burden of disease and life expectancy. The lancet. 2012;380(9838):219-29.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/24/0388
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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