Diabetes Clinical Trial
Official title:
Effect of Rebound Exercises and Circuit Training on Musculoskeletal Pain, Selected Biochemical and Psychosocial Parameters Among Individuals With Type 2 Diabetics
NCT number | NCT03200795 |
Other study ID # | 4198 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 15, 2018 |
Est. completion date | February 20, 2019 |
Background. Diabetes is a global epidemic disease. The prevalence of diabetes for all age
groups worldwide was estimated to be 2.8% in 2000 and is predicted to affect 4.4% by 2030.
The global prevalence of diabetics is currently estimated to be 285 million and projection
rates are expected to rise to over 438 million by the year 2030, with Asians suffering the
bulk of the total diabetes epidemic.
The incidence of chronic diseases of lifestyle such as Type 2 Diabetes Mellitus (DM) is on
the increase amongst the South African population. Due to the numerous factors such as lack
of education, inaccessibility of healthcare facilities and/or poor socio-economic background,
diabetes mellitus often goes undetected in rural areas, resulting in an increase in
musculoskeletal complication and other diabetes mellitus complications. Inability to control
blood sugar may induce serious complications such as renal disease, peripheral neuropathy,
retinopathy, and vascular events. Due to its multi-systemic nature, diabetes will lead to the
development of additional manifestations such as musculoskeletal complications, reduces
respiratory capacity, depression and poor quality of life.
Studies have shown that both exercises and pharmacotherapy can decreases depression and
improved glycemic control and overall quality of life of persons with diabetes. Thus, in
addition improve the quality of life and substantial financial savings and improved medical
care of these individuals.
Hypothesis
1. There will be no statistical significant difference in glycemic control, cholesterol
level, respiratory parameters, pain scores, depression and quality of life among type 2
diabetes patients at the baseline and at the end of 8 weeks of rebound exercises.
2. There will be no statistical significant difference in glycemic control, cholesterol
level, respiratory parameters, pain scores, depression and quality of life among type 2
diabetes patients at the baseline and at the end of 8 weeks of circuit resistance
training.
3. There will be no statistical significant difference in glycemic control, cholesterol
level, respiratory parameters, pain scores, depression and quality of life among type 2
diabetes patients at the baseline and at the end of 8 weeks of routine care.
4. There will be no statistical significant difference in glycemic control, cholesterol
level, respiratory parameters, pain scores, depression and quality of life among type 2
diabetes patients between the rebound exercises group, circuit training and routine care
at the baseline.
5. There will be no statistical significant difference in glycemic control, cholesterol
level, respiratory parameters, pain scores, depression and quality of life among type 2
diabetes patients between the rebound exercises group, circuit training and routine care
at the end of 8 week of the programme.
Summary of the proposed research methodology. The participants will be randomised into three
groups. The first group will be engaged in rebound exercise, the second group will be engaged
in circuit training while the third group will continue with their normal care of medication.
But before the commencement of the study, pilot study will be conducted on normal subjects.
Measurement will be carried out at the baseline, four weeks and at the end of the programme,
'The following parameters will be measured. Pain level, blood glycemic level of each
participant, cholesterol level, depression and quality of life.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | February 20, 2019 |
Est. primary completion date | November 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 55 Years |
Eligibility |
Inclusion Criteria: 1. Subjects with diagnosis of type 2 diabetes for at least 4 years on oral hypoglycemic control 2. Age between 20 to 55 years 3. Musculoskeletal affectation and depression, 4. Consent to participate in the study. Exclusion Criteria: 1. Subjects who are involved in sporting activities 2. Those whose musculoskeletal problems are severe and may prevent them from performing some of the exercises. 3. Individuals with hypertension 4. Coronary artery disease 5. Myocardial infarction 6. Cardiac or abdominal surgery 7. Previous 6 months, history of fractures of the spine, hip, knee and ankle joints 8. Lower limb weakness and deformities with loss of protective sensation in the feet. 9. Pregnancy or lactation 10. Use of insulin 11. Presence of retinopathy, 12. Nephropathy 13. Subjects who do not consent to participate. |
Country | Name | City | State |
---|---|---|---|
Nigeria | Aminu Kano Teaching Hospital | Kano |
Lead Sponsor | Collaborator |
---|---|
University of KwaZulu |
Nigeria,
Arora E, Shenoy S, Sandhu JS. Effects of resistance training on metabolic profile of adults with type 2 diabetes. Indian J Med Res. 2009 May;129(5):515-9. — View Citation
Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. — View Citation
Cohen, J. (1977). Statistical power analysis for the behavioral sciences. Academic Press.
International Diabetes Federation. (2013). IDF Diabetes Atlas. Hallado en: http://www. idf. org/diabetesatlas/5e/es/ …
Maharaj, S. S., & Nuhu, J. M. (2015). The effect of rebound exercise and treadmill walking on the quality of life for patients with non-insulin-dependent type 2 diabetes. International Journal of Diabetes in Developing Countries, 35(October), 223-229. https://doi.org/10.1007/s13410-015-0350-z
Misra A, Alappan NK, Vikram NK, Goel K, Gupta N, Mittal K, Bhatt S, Luthra K. Effect of supervised progressive resistance-exercise training protocol on insulin sensitivity, glycemia, lipids, and body composition in Asian Indians with type 2 diabetes. Diabetes Care. 2008 Jul;31(7):1282-7. doi: 10.2337/dc07-2316. Epub 2008 Mar 3. — View Citation
Odole, A. C., & Akinpelu, A. O. (2009). Translation and Alternate Forms Reliability of the Visual Analogue Scale in the Three Major Nigerian Languages. Pain, 7(3), 1-7.
Pai LW, Hung CT, Li SF, Chen LL, Chung Y, Liu HL. Musculoskeletal pain in people with and without type 2 diabetes in Taiwan: a population-based, retrospective cohort study. BMC Musculoskelet Disord. 2015 Nov 20;16:364. doi: 10.1186/s12891-015-0819-4. — View Citation
Who. (2001). The International Classification of Functioning, Disability and Health. World Health Organization, 18, 237. https://doi.org/10.1097/01.pep.0000245823.21888.71
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Change is being assessed | Musculoskeletal pain will be assess, using visual analog scale (VAS) | Baseline and at the end of eight week of the study | |
Primary | Blood glucose level Change is being assessed | The sugar level will be measure using accutrend plus | Baseline and at the end of eight week of the study | |
Primary | Cholesterol level Change is being assessed | The cholesterol level will be measure using accutrend pus | Baseline and at the end of eight week of the study | |
Secondary | Depression Change is being assessed | The depression will be measure using Beck depression inventory | Baseline and at the end of the eight week of the study | |
Secondary | Quality of life Change is being assessed | The quality of life will be measure using the short form health survey questionnaire (SF-36) | Baseline and at the end of the eight week of the study |
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