NCT02701569

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable type-2-diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
Last Updated

October 27, 2016

Status Verified

February 1, 2016

Enrollment Period

11 months

First QC Date

February 17, 2016

Last Update Submit

October 26, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Glycated hemoglobin

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

    3 months

Secondary Outcomes (16)

  • Fasting plasma glucose

    3 months

  • Fasting insulin

    3 months

  • High-density lipoprotein cholesterol

    3 months

  • Total cholesterol

    3 months

  • Triglycerides

    3 months

  • +11 more secondary outcomes

Other Outcomes (1)

  • Depressive symptoms as measured by the Beck's Depression Inventory

    3 months

Study Arms (2)

Rebound exercise

EXPERIMENTAL

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

Other: Rebound exercise

Control

NO INTERVENTION

No exercise was administered but participants continued with routine medical care

Interventions

Repeated jumping on a mini trampoline was administered

Also known as: Mini trampoline rebounding
Rebound exercise

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Sonill S Maharaj, PhD

    UKZN

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2016

First Posted

March 8, 2016

Study Start

July 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

October 27, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Data would not be shared