- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02701569
Effect of Rebound Exercise in Individuals With Type 2 Diabetes
October 26, 2016 updated by: University of KwaZulu
Effect of Rebound Therapy on Metabolic Outcomes and Quality of Life in Nigerian Patients With Type 2 Diabetes
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Rebound exercise
Repeated jumping on a mini trampoline was performed with feet slightly apart
|
Repeated jumping on a mini trampoline was administered
Other Names:
|
|
No Intervention: Control
No exercise was administered but participants continued with routine medical care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glycated hemoglobin
Time Frame: 3 months
|
Glycated hemoglobin was assessed using the mini-column ion-exchange chromatographic method and expressed in percentage
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fasting plasma glucose
Time Frame: 3 months
|
Fasting plasma glucose (in molar concentration) was measured by glucose oxidase assay using a glucose analyzer
|
3 months
|
|
Fasting insulin
Time Frame: 3 months
|
Fasting insulin (in gravimetric unit) was determined using a commercially available ELISA human insulin kit
|
3 months
|
|
High-density lipoprotein cholesterol
Time Frame: 3 months
|
High-density lipoprotein cholesterol (in molar concentration) was enzymatically determined using commercial kits
|
3 months
|
|
Total cholesterol
Time Frame: 3 months
|
Total cholesterol (in molar concentration) was enzymatically determined using commercial kits
|
3 months
|
|
Triglycerides
Time Frame: 3 months
|
Triglycerides (in molar concentration) were enzymatically determined using commercial kits
|
3 months
|
|
Low-density lipoprotein cholesterol
Time Frame: 3 months
|
Low-density lipoprotein cholesterol (in molar concentration) was estimated using the Friedewald formula.
|
3 months
|
|
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
|
3 months
|
|
Body mass
Time Frame: 3 months
|
Body mass in kilograms was determined using a calibrated weighing scale
|
3 months
|
|
Height
Time Frame: 3 months
|
Height in meters was determined using a stadiometer
|
3 months
|
|
Heart rate
Time Frame: 3 months
|
Heart rate was measured in beats per minute using a calibrated electronic device
|
3 months
|
|
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
|
3 months
|
|
Blood pressure
Time Frame: 3 months
|
Blood pressure in millimeters of mercury (mmHg) was measured using a calibrated electronic device
|
3 months
|
|
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
|
3 months
|
|
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
|
3 months
|
|
Well-Being as measured by the World Health Organization-Well-Being Index
Time Frame: 3 months
|
Participants' well-being was expressed in percentage
|
3 months
|
|
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)
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Sonill S Maharaj, PhD, UKZN
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
February 17, 2016
First Submitted That Met QC Criteria
March 2, 2016
First Posted (Estimate)
March 8, 2016
Study Record Updates
Last Update Posted (Estimate)
October 27, 2016
Last Update Submitted That Met QC Criteria
October 26, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BF389/13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Data would not be shared
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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