Promoting Physical Activity in Patients With Type 2 Diabetes (DIAfit)

NCT ID: NCT01289587

Last Updated: 2020-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2017-10-31

Brief Summary

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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.

Detailed Description

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The aim of this study is

1. to evaluate the effects (before and after) of a physical activity program (DIAfit program) which contains 36 sessions of structured PA and also encourages unstructured PA in an unselected population of patients with type 2 diabetes independent of the selected variant of the program
2. to compare the effects of a standard DIAfit program (3 times per week for 12 weeks) with and alternative program which suggests a more progressive PA activity intensity (starting with one PA session per week during 4 weeks and then twice a week over a period of 16 more weeks (20 weeks total). In total the program also consist of 36 sessions)

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Alternative frequency variant

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)

Group Type EXPERIMENTAL

Physical activity intervention

Intervention Type BEHAVIORAL

36 sessions of physical activity offered at different frequencies

Standard frequency program

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

Group Type ACTIVE_COMPARATOR

Physical activity intervention

Intervention Type BEHAVIORAL

36 sessions of physical activity offered at different frequencies

Interventions

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Physical activity intervention

36 sessions of physical activity offered at different frequencies

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of type 2 diabetes

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role collaborator

University of Lausanne Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Jardena Puder

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Lausanne Hospitals

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 37484961 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27732627 (View on PubMed)

Related Links

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http://www.diafit.ch

Website of the program

Other Identifiers

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252/10

Identifier Type: -

Identifier Source: org_study_id

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