NCT01393275

Brief Summary

The purposes of the study are

  • to determine if a supervised exercise intervention is improving the metabolic parameters in type 2 diabetes patients
  • to investigate what kind of intervention (strength endurance training versus combined strength endurance training and rehabilitation exercise intervention)is more effective in improving the metabolic parameters in patients with type 2 diabetes
  • to assess which exercise intervention induces higher effects to the metabolic rate and cardiac and pulmonary capacity
  • to investigate what kind of intervention includes highest effects in long term persistence of these positive effects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

Enrollment Period

9 months

First QC Date

July 12, 2011

Last Update Submit

November 5, 2011

Conditions

DiabetesDiabetes Mellitus, Non-Insulin-Dependent

Keywords

diabetesexerciseinterventionrehabilitationmetabolic ratesport

Outcome Measures

Primary Outcomes (1)

  • alteration of HbA1c-level (haemoglobin A1c)

    6 months

Secondary Outcomes (12)

  • alteration of total cholesterol level

    6 months

  • alteration of LDL-cholesterol-level

    6 months

  • alteration of HDL-cholesterol-level

    6 months

  • alteration of triglyceride-level

    6 months

  • alteration of antidiabetic medications

    6 months

  • +7 more secondary outcomes

Study Arms (2)

Rehabilitation intervention group

ACTIVE COMPARATOR

The group is performing a strength endurance training intervention in addition with rehabilitation exercise intervention.

Other: rehabilitation exercise intervention

Placebo rehabilitation

PLACEBO COMPARATOR

The group is performing a strength endurance training intervention in addition with placebo rehabilitation exercise intervention.

Other: placebo control group

Interventions

rehabilitation exercise interventionOTHER

exercise intervention: 15 minutes warm up, 30 minutes strength endurance training, 60 minutes rehabilitation exercise training - once a week 15 minutes warm up, 30 minutes strength endurance training - once a week

Rehabilitation intervention group
placebo control groupOTHER

exercise intervention: 15 minutes warm up, 30 minutes strength endurance training, 5 minutes walking 55 minutes conversation in the group- once a week 15 minutes warm up, 30 minutes strength endurance training - once a week

Placebo rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of type 2 diabetes (ADA criteria)
  • admitted diabetes treatment will be diet and oral hypoglycemic agents

You may not qualify if:

  • sports intervention \> 60 minutes per week
  • medical conditions
  • proliferative retinopathy
  • instable coronary heart disease
  • acute clinically significant intercurrent disease
  • inability to perform scheduled physical activity programs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Giessen

Giessen, Hesse, 35394, Germany

Location

Sportpark Zwickau, Glauchau, Meerane

Zwickau, Saxony, 08056, Germany

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Andree Hillebrecht, Dr. med.

    University of Giessen

    STUDY CHAIR

  • Dusan Hamar, Prof. Dr.

    Comenius University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Akad. Rat

Study Record Dates

First Submitted

July 12, 2011

First Posted

July 13, 2011

Study Start

February 1, 2010

Primary Completion

November 1, 2010

Study Completion

October 1, 2011

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations

DE(2)