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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Mini trampoline rebounding
No Intervention: Control
No exercise was administered but participants continued with routine medical care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of KwaZulu

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aminu Kano Teaching Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings