Study Results
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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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2024-08-25
2026-07-31
Brief Summary
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Objective: to evaluate the feasibility of exercise in the reversibility of prediabetes after transplantation, as a first step to prevent Post-Transplant Diabetes Mellitus (PTDM).
Methodology: a total of 50 patients with prediabetes beyond 12 months after transplantation with capacity to perform exercise will be randomized to standard life-style recommendations as per clinical practice (n=25) or to a stepped ad-hoc designed training intervention (n=25). Prediabetes will be diagnosed based on fasting glucose levels and an Oral Glucose Tolerance Test (OGTT). Patients randomized to exercise will start with aerobic exercise training 5 times/week, 30 min/day for 12 months which may be gradually increased to 60 min/day or combined with strength exercise in the last increment in case of prediabetes persistence. The reversibility/persistence/relapse of prediabetes will be measured with fasting glucose and OGTT every 3 months. The study will last 12 months.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Exercise group
The experimental group will receive an ad hoc designed stepped exercise intervention supported by adherence monitoring.
Therapeutic exercise
A stepped training intervention designed ad hoc based on a combination of aerobic and strength exercises.
Control group
The control group will follow standard lifestyle recommendations according to clinical practice.
No interventions assigned to this group
Interventions
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Therapeutic exercise
A stepped training intervention designed ad hoc based on a combination of aerobic and strength exercises.
Eligibility Criteria
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Inclusion Criteria
* ≥ 12 months post kidney transplant
* Stable renal function in the last 3-6 months
* Prediabetes (abnormal fasting glucose 100-125 mg/dl and/or glucose intolerance 140-199mg/dl)
* Ability to perform exercise
Exclusion Criteria
* Inability to understand the protocol
* Severe psychological illness
* PTDM and/or DM prior to transplantation
* Morbid obesity
18 Years
ALL
No
Sponsors
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Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias
OTHER
University of La Laguna
OTHER
Responsible Party
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Raúl Morales Febles
PhD-Physiotherapist
Locations
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University of La Laguna
San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain
Countries
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Other Identifiers
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CHUC_2022_40
Identifier Type: -
Identifier Source: org_study_id
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