NCT01289587

Brief Summary

The aim of this study is to evaluate the effects of a physical activity intervention in patients with type 2 diabetes in a community setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
185

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

January 28, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

January 28, 2011

Last Update Submit

March 23, 2020

Conditions

Diabetes

Keywords

DiabetesPhysical activityBody compositionAerobic fitnessMetabolic control

Outcome Measures

Primary Outcomes (1)

  • Aerobic fitness

    Change in aerobic fitness

    End of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)

Secondary Outcomes (10)

  • Body composition

    At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)

  • BMI

    At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)

  • HbA1c

    At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)

  • Lipid values

    At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)

  • Motor performance

    At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)

  • +5 more secondary outcomes

Study Arms (2)

Alternative frequency variant

EXPERIMENTAL

An alternative variant of the DIAfit program (progressive increase of the number of administered PA sessions per week, namely one PA session per week during 4 weeks and then twice a week over a period of 16 weeks)

Behavioral: Physical activity intervention

Standard frequency program

ACTIVE COMPARATOR

Standard usual program (3 times per week over a period of 12 weeks)

Behavioral: Physical activity intervention

Interventions

Physical activity interventionBEHAVIORAL

36 sessions of physical activity offered at different frequencies

Alternative frequency variantStandard frequency program

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of type 2 diabetes

You may not qualify if:

  • Orthopedic complications
  • Diabetic foot ulceration
  • "Active " cardiac (ischemia during the exercise test) or stade III peripheral vascular disease
  • Untreated proliferative retinopathy
  • Autonomic neuropathy
  • Active psychiatric, neurological, orthopedic, muscular or rheumatic disease interfering with a participation in a physical activity program
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lausanne Hospitals

Lausanne, 1011, Switzerland

Location

Related Publications (2)

  • Arhab A, Junod N, Rossel JB, Giet O, Sittarame F, Beer S, Sofra D, Durrer D, Delgado H, Castellsague M, Laimer M, Puder JJ. Effectiveness of a real-life program (DIAfit) to promote physical activity in patients with type 2 diabetes: a pragmatic cluster randomized clinical trial. Front Endocrinol (Lausanne). 2023 Jul 3;14:1155217. doi: 10.3389/fendo.2023.1155217. eCollection 2023.

    PMID: 37484961DERIVED

  • Allet L, Giet O, Barral J, Junod N, Durrer D, Amati F, Sykiotis GP, Marques-Vidal P, Puder JJ. Educational Level Is Related to Physical Fitness in Patients with Type 2 Diabetes - A Cross-Sectional Study. PLoS One. 2016 Oct 12;11(10):e0164176. doi: 10.1371/journal.pone.0164176. eCollection 2016.

    PMID: 27732627DERIVED

Related Links

MeSH Terms

Conditions

Diabetes MellitusMotor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 28, 2011

First Posted

February 4, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2012

Study Completion

October 1, 2017

Last Updated

March 24, 2020

Record last verified: 2020-03

Locations

CH(1)