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Effect of Rebound Exercise in Individuals With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02701569
Recruitment Status : Completed
First Posted : March 8, 2016
Last Update Posted : October 27, 2016
Sponsor:
Collaborator:
Aminu Kano Teaching Hospital
Information provided by (Responsible Party):
University of KwaZulu

Brief Summary:
The purpose of this study was to investigate the effect of rebound exercise (mini trampoline jumping) on metabolic outcomes and quality of life in patients with Type 2 Diabetes.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: Rebound exercise Not Applicable

Detailed Description:
The exercise involved jumping on the mini trampoline with feet slightly apart. Participants stood on the mid portion of the trampoline bed and made repeated up-and-down bouncy movements. Each foot strike equals one step or bounce. With each landing, the mat of the trampoline underwent deformation and the springs released the energy stored in them such that the participant was made to bounce off the mat. Exercise was administered for between 10 - 15 minutes after which a 5-minute period of rest was allowed. A heart rate monitor was used to guide the intensity of the exercise in the moderate range. Each participant accumulated between 20 and 30 minutes of rebound exercise (bouncing on a mini trampoline) per session, administered three times per week for 12 weeks. All data were captured at baseline and at the end of the 12-week intervention period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Rebound Therapy on Metabolic Outcomes and Quality of Life in Nigerian Patients With Type 2 Diabetes
Study Start Date : July 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rebound exercise
Repeated jumping on a mini trampoline was performed with feet slightly apart
Other: Rebound exercise
Repeated jumping on a mini trampoline was administered
Other Name: Mini trampoline rebounding

No Intervention: Control
No exercise was administered but participants continued with routine medical care



Primary Outcome Measures :
  1. Glycated hemoglobin [ Time Frame: 3 months ]
    Glycated hemoglobin was assessed using the mini-column ion-exchange chromatographic method and expressed in percentage


Secondary Outcome Measures :
  1. Fasting plasma glucose [ Time Frame: 3 months ]
    Fasting plasma glucose (in molar concentration) was measured by glucose oxidase assay using a glucose analyzer

  2. Fasting insulin [ Time Frame: 3 months ]
    Fasting insulin (in gravimetric unit) was determined using a commercially available ELISA human insulin kit

  3. High-density lipoprotein cholesterol [ Time Frame: 3 months ]
    High-density lipoprotein cholesterol (in molar concentration) was enzymatically determined using commercial kits

  4. Total cholesterol [ Time Frame: 3 months ]
    Total cholesterol (in molar concentration) was enzymatically determined using commercial kits

  5. Triglycerides [ Time Frame: 3 months ]
    Triglycerides (in molar concentration) were enzymatically determined using commercial kits

  6. Low-density lipoprotein cholesterol [ Time Frame: 3 months ]
    Low-density lipoprotein cholesterol (in molar concentration) was estimated using the Friedewald formula.

  7. Quality of life [ Time Frame: 3 months ]
    The short-form 36 health questionnaire was used to assess participants' quality of life and expressed in percentage

  8. Body mass [ Time Frame: 3 months ]
    Body mass in kilograms was determined using a calibrated weighing scale

  9. Height [ Time Frame: 3 months ]
    Height in meters was determined using a stadiometer

  10. Heart rate [ Time Frame: 3 months ]
    Heart rate was measured in beats per minute using a calibrated electronic device

  11. Respiratory rate [ Time Frame: 3 months ]
    Respiratory rate (in cycles per minute) was measured by observing and counting the number of times the chest rose in one minute

  12. Blood pressure [ Time Frame: 3 months ]
    Blood pressure in millimeters of mercury (mmHg) was measured using a calibrated electronic device

  13. Maximal oxygen consumption [ Time Frame: 3 months ]
    Maximal oxygen consumption in milliliters per kilogram per minute (ml/kg/min) was obtained from exercise stress testing

  14. Diabetes-related emotional distress as measured by the Problem Areas in Diabetes Scale [ Time Frame: 3 months ]
    Diabetes-related emotional distress was expressed in percentage

  15. Well-Being as measured by the World Health Organization-Well-Being Index [ Time Frame: 3 months ]
    Participants' well-being was expressed in percentage

  16. Treatment satisfaction as measured by the World Health Organization-Diabetes Treatment Satisfaction Questionnaire [ Time Frame: 3 months ]
    Score ranges from 0 (very dissatisfied) to 36 (very satisfied)


Other Outcome Measures:
  1. Depressive symptoms as measured by the Beck's Depression Inventory [ Time Frame: 3 months ]
    Score ranges from 0 to 63 with 0 to 13 being minimal and 29 to 63 being severe



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 30- to 60-year-old male and female individuals;
  • A diagnosis of type 2 diabetes ≤ 5 years;
  • Attendance at the Diabetes Outpatient Clinics of Aminu Kano Teaching Hospital and Murtala Muhammad Specialist Hospital in Kano, Northwestern Nigeria;
  • Self-ambulatory;
  • An inactive lifestyle over the last year.

Exclusion Criteria:

  • A diagnosis of type 2 diabetes for more than 5 years;
  • Hypertension (systolic and diastolic blood pressure more than 140 and 90 mmHg, respectively) or treatment for hypertension;
  • Use of insulin therapy
  • Lower limb weakness and/or deformities with loss of protective sensation in the feet;
  • Back, shoulder or knee problems and/or joint instability;
  • History of coronary artery disease, retinopathy and nephropathy;
  • Myocardial infarction, cardiac or abdominal surgery within the previous 6 months;
  • History of fractures of the spine, hip, knee and/or ankle joints.

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): NCT02701569


Sponsors and Collaborators
University of KwaZulu
Aminu Kano Teaching Hospital
Investigators
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Study Chair: Sonill S Maharaj, PhD UKZN

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Responsible Party: University of KwaZulu
ClinicalTrials.gov Identifier: NCT02701569     History of Changes
Other Study ID Numbers: BF389/13
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data would not be shared
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases