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Effect of Different Exercises on Musculoskeletal Pain,Glucose Level and Quality of Life Among Patients With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200795
Recruitment Status : Unknown
Verified June 2017 by University of KwaZulu.
Recruitment status was:  Recruiting
First Posted : June 27, 2017
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
University of KwaZulu

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Diabetes Other: Rebound exercise Other: Circuit training exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: There will be 3 group, the rebound exercise group, circuit training group and the control group. The rebound exercises group will received rebound exercise therapy while circuit training will received circuit exercises that comprises progressive resistance exercise and aerobic exercises, while control group will be treated based on the guideline of the management of diabetes by international diabetes federation. Also the two exercise group will received their routine care plus exercises.
Masking: Single (Participant)
Masking Description: To eliminate bias, the assessment of outcome will be performed by (experienced) blinded assessors, who will be blinded to the type of intervention as well as the intervention groups of the participants. Participants will also be instructed not to disclose their individual intervention groups to the assessors
Primary Purpose: Treatment
Official Title: Effect of Rebound Exercises and Circuit Training on Musculoskeletal Pain, Selected Biochemical and Psychosocial Parameters Among Individuals With Type 2 Diabetics
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : November 20, 2018
Estimated Study Completion Date : February 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rebound exercise group
Participants randomized to this group will be instructed on the proper techniques of the desired movements (hopping) on the rebounder.
Other: Rebound exercise

Each participant will undergo 3 sessions a week for 8 weeks with each session lasting 20 minutes. Bouncing frequency will be determined by signals from an metronom and will be set at between 90 and 120 bounces per minute. Heart rate training zone will be maintained, during the exercise, at moderate intensity of 40-60% and will be calculated using the Karvonen formula ([Heart rate reserve x training percentage] + resting heart rate)(Nuhu & Maharaj, 2017).

The exercise will involve bouncing on the center portion of the mini trampoline (Portable 2013 Model Half-Fold Cellerciser with feet slightly apart and knees in full extension. Each foot strike equaled one step or bounce with step height, this will be defined as the distance between the foot at maximum height of jump and the bed of the center of the trampoline ranging between 10 and 15 cm (Nuhu & Maharaj, 2017).


Experimental: Circuit training group
The circuit training for the participants in this group will be designed for each participant. Training will take place 3 times a week for 8 weeks. The participants will undergo 10 minutes warm up before and 10 minutes cool down after the training. Resistance exercises will be performed on weight machines. Throughout the resistance training program, participants will be alternating between the bench press, seated row, lateral pull down, biceps forward, front thigh, back thigh, leg press and rowing.
Other: Circuit training exercise

Participants will be instructed to exhale while lifting a weight and inhale while lowering it, to minimize blood pressure excursions, and to rest for 2 to 3 minutes between sets. Participants will perform 1 set per resistance exercise three time weekly for the first 2 weeks and 4 sets of each resistance exercise three time weekly during weeks 3 and 4. Resistance will be increase by 5 to 10 kg when the participant could perform more than 15 repetitions while maintaining proper form.

All aerobic activities of the circuit training will be performed on a cycle ergometer or treadmill. Participants are free to vary the machine used from one visit to the next. Exercise intensity will be standardized by using heart rate monitors (Polar Electro Oy) that will display the participant's heart rate and emitted a warning signal when the heart rate was outside the prescribed training zone, thus guiding the participant in adjusting the workload up or down to achieve the desired intensity.





Primary Outcome Measures :
  1. Pain Change is being assessed [ Time Frame: Baseline and at the end of eight week of the study ]
    Musculoskeletal pain will be assess, using visual analog scale (VAS)

  2. Blood glucose level Change is being assessed [ Time Frame: Baseline and at the end of eight week of the study ]
    The sugar level will be measure using accutrend plus

  3. Cholesterol level Change is being assessed [ Time Frame: Baseline and at the end of eight week of the study ]
    The cholesterol level will be measure using accutrend pus


Secondary Outcome Measures :
  1. Depression Change is being assessed [ Time Frame: Baseline and at the end of the eight week of the study ]
    The depression will be measure using Beck depression inventory

  2. Quality of life Change is being assessed [ Time Frame: Baseline and at the end of the eight week of the study ]
    The quality of life will be measure using the short form health survey questionnaire (SF-36)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200795


Contacts
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Contact: Sonill Maharaj, PhD +27834611413 ext 7938 maharajss@ukzn.ac.za
Contact: Jeanne Grace, PhD +27832331523 grace@ukzn.ac.za

Locations
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Nigeria
Aminu Kano Teaching Hospital Recruiting
Kano, Nigeria, 70000
Contact: Badaru Umar, PhD    08028460237    badaruum@gmail.com   
Contact: Sammani Jibril, Msc       jsammani.pth@buk.edu.ng   
Sponsors and Collaborators
University of KwaZulu
Publications:
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
Cohen, J. (1977). Statistical power analysis for the behavioral sciences. Academic Press.
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.
International Diabetes Federation. (2013). IDF Diabetes Atlas. Hallado en: http://www. idf. org/diabetesatlas/5e/es/ …
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of KwaZulu
ClinicalTrials.gov Identifier: NCT03200795    
Other Study ID Numbers: 4198
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of KwaZulu:
Diabetes
Musculoskelatal pain
Rebound exercises
Depression
Glucose
Quality of life
Additional relevant MeSH terms:
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Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms