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Effect of Rebound Exercise in Individuals With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rebound exercise
Sponsored by
University of KwaZulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Rebound exercise

    Control

    Arm Description

    Repeated jumping on a mini trampoline was performed with feet slightly apart

    No exercise was administered but participants continued with routine medical care

    Outcomes

    Primary Outcome Measures

    Glycated hemoglobin
    Glycated hemoglobin was assessed using the mini-column ion-exchange chromatographic method and expressed in percentage

    Secondary Outcome Measures

    Fasting plasma glucose
    Fasting plasma glucose (in molar concentration) was measured by glucose oxidase assay using a glucose analyzer
    Fasting insulin
    Fasting insulin (in gravimetric unit) was determined using a commercially available ELISA human insulin kit
    High-density lipoprotein cholesterol
    High-density lipoprotein cholesterol (in molar concentration) was enzymatically determined using commercial kits
    Total cholesterol
    Total cholesterol (in molar concentration) was enzymatically determined using commercial kits
    Triglycerides
    Triglycerides (in molar concentration) were enzymatically determined using commercial kits
    Low-density lipoprotein cholesterol
    Low-density lipoprotein cholesterol (in molar concentration) was estimated using the Friedewald formula.
    Quality of life
    The short-form 36 health questionnaire was used to assess participants' quality of life and expressed in percentage
    Body mass
    Body mass in kilograms was determined using a calibrated weighing scale
    Height
    Height in meters was determined using a stadiometer
    Heart rate
    Heart rate was measured in beats per minute using a calibrated electronic device
    Respiratory rate
    Respiratory rate (in cycles per minute) was measured by observing and counting the number of times the chest rose in one minute
    Blood pressure
    Blood pressure in millimeters of mercury (mmHg) was measured using a calibrated electronic device
    Maximal oxygen consumption
    Maximal oxygen consumption in milliliters per kilogram per minute (ml/kg/min) was obtained from exercise stress testing
    Diabetes-related emotional distress as measured by the Problem Areas in Diabetes Scale
    Diabetes-related emotional distress was expressed in percentage
    Well-Being as measured by the World Health Organization-Well-Being Index
    Participants' well-being was expressed in percentage
    Treatment satisfaction as measured by the World Health Organization-Diabetes Treatment Satisfaction Questionnaire
    Score ranges from 0 (very dissatisfied) to 36 (very satisfied)

    Full Information

    First Posted
    February 17, 2016
    Last Updated
    October 26, 2016
    Sponsor
    University of KwaZulu
    Collaborators
    Aminu Kano Teaching Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02701569
    Brief Title
    Effect of Rebound Exercise in Individuals With Type 2 Diabetes
    Official Title
    Effect of Rebound Therapy on Metabolic Outcomes and Quality of Life in Nigerian Patients With Type 2 Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of KwaZulu
    Collaborators
    Aminu Kano Teaching Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Rebound exercise
    Arm Type
    Experimental
    Arm Description
    Repeated jumping on a mini trampoline was performed with feet slightly apart
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    No exercise was administered but participants continued with routine medical care
    Intervention Type
    Other
    Intervention Name(s)
    Rebound exercise
    Other Intervention Name(s)
    Mini trampoline rebounding
    Intervention Description
    Repeated jumping on a mini trampoline was administered
    Primary Outcome Measure Information:
    Title
    Glycated hemoglobin
    Description
    Glycated hemoglobin was assessed using the mini-column ion-exchange chromatographic method and expressed in percentage
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Fasting plasma glucose
    Description
    Fasting plasma glucose (in molar concentration) was measured by glucose oxidase assay using a glucose analyzer
    Time Frame
    3 months
    Title
    Fasting insulin
    Description
    Fasting insulin (in gravimetric unit) was determined using a commercially available ELISA human insulin kit
    Time Frame
    3 months
    Title
    High-density lipoprotein cholesterol
    Description
    High-density lipoprotein cholesterol (in molar concentration) was enzymatically determined using commercial kits
    Time Frame
    3 months
    Title
    Total cholesterol
    Description
    Total cholesterol (in molar concentration) was enzymatically determined using commercial kits
    Time Frame
    3 months
    Title
    Triglycerides
    Description
    Triglycerides (in molar concentration) were enzymatically determined using commercial kits
    Time Frame
    3 months
    Title
    Low-density lipoprotein cholesterol
    Description
    Low-density lipoprotein cholesterol (in molar concentration) was estimated using the Friedewald formula.
    Time Frame
    3 months
    Title
    Quality of life
    Description
    The short-form 36 health questionnaire was used to assess participants' quality of life and expressed in percentage
    Time Frame
    3 months
    Title
    Body mass
    Description
    Body mass in kilograms was determined using a calibrated weighing scale
    Time Frame
    3 months
    Title
    Height
    Description
    Height in meters was determined using a stadiometer
    Time Frame
    3 months
    Title
    Heart rate
    Description
    Heart rate was measured in beats per minute using a calibrated electronic device
    Time Frame
    3 months
    Title
    Respiratory rate
    Description
    Respiratory rate (in cycles per minute) was measured by observing and counting the number of times the chest rose in one minute
    Time Frame
    3 months
    Title
    Blood pressure
    Description
    Blood pressure in millimeters of mercury (mmHg) was measured using a calibrated electronic device
    Time Frame
    3 months
    Title
    Maximal oxygen consumption
    Description
    Maximal oxygen consumption in milliliters per kilogram per minute (ml/kg/min) was obtained from exercise stress testing
    Time Frame
    3 months
    Title
    Diabetes-related emotional distress as measured by the Problem Areas in Diabetes Scale
    Description
    Diabetes-related emotional distress was expressed in percentage
    Time Frame
    3 months
    Title
    Well-Being as measured by the World Health Organization-Well-Being Index
    Description
    Participants' well-being was expressed in percentage
    Time Frame
    3 months
    Title
    Treatment satisfaction as measured by the World Health Organization-Diabetes Treatment Satisfaction Questionnaire
    Description
    Score ranges from 0 (very dissatisfied) to 36 (very satisfied)
    Time Frame
    3 months
    Other Pre-specified Outcome Measures:
    Title
    Depressive symptoms as measured by the Beck's Depression Inventory
    Description
    Score ranges from 0 to 63 with 0 to 13 being minimal and 29 to 63 being severe
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sonill S Maharaj, PhD
    Organizational Affiliation
    UKZN
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Data would not be shared

    Learn more about this trial

    Effect of Rebound Exercise in Individuals With Type 2 Diabetes

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