Effect of Rebound Exercise in Individuals With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Effect of Rebound Therapy on Metabolic Outcomes and Quality of Life in Nigerian Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02701569
• Other study ID #: BF389/13
• Status: Completed
• Phase: N/A
• First received: February 17, 2016
• Last updated: October 26, 2016
• Start date: July 2014
• Est. completion date: June 2015

Study information

• Verified date: February 2016
• Source: University of KwaZulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Nigeria: Federal Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Rebound exercise
Repeated jumping on a mini trampoline was administered

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of KwaZulu	Aminu Kano Teaching Hospital

Outcome

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