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Effects of exercise and antioxidant supplementation in individuals with diabetes kidney disease

Controlled and randomised clinical study on the effects of exercise associated with antioxidant supplementation on redox and immuno-metabolic regulation in patients with diabetes renal disease

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10fghxtm
Enrollment
Unknown
Registered
2021-11-30
Start date
2022-03-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glomerular disorders in diabetes mellitus, kidney disease, glomerular disorders in endocrine, nutritional and metabolic diseases, inflammation

Interventions

The study protocol will be randomized controlled, crossover type. Composed of 120 patients with renal diabetes disease, of both sexes (female and male) and divided into 2 groups (experimental and cont
E02.760.169.063.500.387.250
G07.203.300.456

Sponsors

Pontifícia Universidade Católica do Paraná
Lead Sponsor
Pontifícia Universidade Católica do Paraná
Collaborator

Eligibility

Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: Female and male; ages 40 to 65; staging of chronic kidney disease 3 and 4 degree; body mass index: lower than obesity grade 2; glomerular filtration rate estimated by the equation developed by Chronic Renal Disease Epidemiology Collaboration (CKDEPI) and according to stage 3 and 4; presence of optimized drug therapy and without the prediction of change in drug doses of renin-angiotensin aldosterone system blockers, mineralocorticoid antagonist or sodium cotransporter inhibitors and glucose with stable doses up to 4 weeks prior to randomization and during the 7 months of intervention.

Exclusion criteria

Exclusion criteria: Heart failure; severe coronary heart disease indicating physical activity or cardiovascular surgery (e.g. coronary bypass, valvar exchange or angioplasty) within the last 6 months; uncontrolled cardiovascular disease; percentage of glycated haemoglobin greater than 9; chronic lung disease; active viral infections; neurological and mental disorders, musculoskeletal impairment that prevents physical exercise, malignancy (except epidermoid carcinoma) or debilitating and warfarin users.

Design outcomes

Primary

MeasureTime frame
It is expected to find significant effects of the physical training program or associated with supplemental antioxidant therapy in clinical rehabilitation and improve the quality of life of patients with diabetes kidney disease. We will verify whether the multi-component exercises combined with the supplementation will present improvement of the physiopathology of the patients or staging of the disease from the clinical indicators of (clinical, nutritional and anthropometric evaluation), biochemical and molecular parameters of redox and immunometabolic biology, in addition to evaluating the improvement in the quality of life of these patients, through methods of evaluation of physical activity levels and potential variables modifying the effect of interventions, from questionnaires: (World Health Organisation Quality of Life Assessment Tool (WHOQOL); Environmental Perception Scale for Physical Activity Practice (PANES); measures based on the Geographical Information System).

Secondary

MeasureTime frame
From the finding of the significant effects of physical exercise or associated with supplementary therapy, evaluate the possible psychosocial interactions and environments that impact on the levels of habitual physical activity and are expected to affect the quality of life of the pre and post intervention patients, verified pre- and post-intervention through specific questionnaires.;Evaluate the effects of physical training or associated with supplemental antioxidant therapy in controlling clinical and biochemical parameters of patients related to metabolism and pre- and post-intervention renal function.;Evaluating the effects of physical training or associated with supplemental antioxidant therapy will show significant improvement in body composition and physical fitness by measuring cineanthropometric data (weight, height, waist circumferences, hip and panturrille, percentage of fat and lean mass) and measurement (strength and muscle strength by bending test and elbow extension for 30 seconds; Manual Preemption Force Test by Dynamometry) and Cardiorespiratory Capacity (evaluate treadmill walking and 6 minute walking test). In addition to evaluating an improvement in nutritional evaluation with reduction of score score of evaluation questionnaires. ;Evaluating the effects of physical training or associated with supplemental antioxidant therapy will show reduction of oxidative, metabolic and inflammatory stress markers in patients with diabetes kidney disease. By determining oxidants by spectrophotometry, they will be measured (systemic redox sensors and antioxidant capacity indicators) and oxidative damage by means of high-performance liquid chromatography. For metabolic parameters we will check through analyses by specific kits and inflammatory markers through immunoenzymatic test kits.

Countries

Brazil

Contacts

Public ContactAmanda Costa
amandakruger91@gmail.com+55(41)98893-6161

Outcome results

None listed

Source: REBEC (via WHO ICTRP)