Skip to content

Resistance Training in Intradialysis Patients

Phase 1 RCT of Progressive Resistance Training on Small Solute Clearance, Functional Capacity and Quality of Life in Intradialysis Patients

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01065389
Acronym
DIAPRE
Enrollment
46
Registered
2010-02-09
Start date
2010-10-31
Completion date
2016-08-31
Last updated
2013-09-10

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

Conditions

Dialysis, End Stage Renal Disease

Keywords

Intradialysis, Resistance training, Protein Catabolic Rate, Urea kinetics, Quality of life, VO2 max

Brief summary

Dialysis patients usually have peripheral muscle weakness due to metabolic disturbances (increased protein catabolism) and fatigue. This muscle weakness may decrease functional capacity and quality of life. It also serves to increase cardiovascular risk factors in these end stage renal disease patients. Peripheral muscle strength training shall combat physical inactivity during dialysis. In the investigators trial, the investigators hypothesis that peripheral muscle training might regulate protein catabolic rate,renal functions, cardiovascular risk factors, improve functional capacity and quality of life in endstage renal disease patients undergoing dialysis.

Detailed description

End stage renal failure patients undergoing dialysis have profound muscle wasting, reduced functional capacity and quality of life due to uremia, steroids, frequent dialysis and fatigue. During dialysis, physical inactivity further deteriorates the patient's functional capacity. Aerobic or strength training may combat this physical inactivity. It may also improve the functional capacity and quality of life. Recent studies have claimed the benefits of resistance exercises in improving functional capacity. But they have not documented effects on kidney function (electrolyte and urea kinetics) and muscle wasting (protein catabolic rate). In our trial, we attempt to study the effects of resistance training in improvement of renal function and muscle wasting apart from functional capacity and quality of life in dialysis patients

Interventions

Progressive Resistance Exercise Training thrice a week for 12 weeks. For first two weeks, 60% of 5 repetition maximum, progressing at 5% of 5 repetition maximum each week reaching upto 110% of 5 Repetition maximum at the end of 12 weeks

BEHAVIORALUnstructured Nonprogressive resistance exercise

Unstructured Resistance Exercise 30 minutes a day, thrice a week for 12 weeks. For 12 weeks, 20% 5 repetition maximum (which will not induce training effect and any physiological responses)and free range of motion exercises with no progression.

Sponsors

Sikkim Manipal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Must have end stage renal disease (diagnosed and the stage graded by nephrologist or the intensivist concerned) for more than 6 months and dialysis for at least 3 months (the impact of exercise training can be easily assessed) * Must be between the ages of 30 - 60 years of age/ both genders. * Must be able to understand the purpose of exercise testing and resistance training.

Exclusion criteria

* Those with acute nephritic syndrome and hematuria \< 2 months. * Those with profound anemia and blood transfusion \< 2 months * Those underwent renal transplantation \< 6 months. * Those receiving/ received cytotoxic drugs - amiloride, azathioprine/ aspirin (antiplatelets)\< 2 months * Those with coagulation disorders or under anticoagulants \< 4 months. * Those underwent recent cardiac surgeries and with recent unstable cardiac failures * Those with recent cerebrovascular accidents \< 6 months * Those have recent urinary tract infections, Renal and bladder carcinomas \< 2 months * Those with absolute contraindications for resistance exercise training (as per American College of Sports Medicine.

Design outcomes

Primary

MeasureTime frame
Serum and Urea biochemistry - electrolytes (Na, K+), serum albumin, inflammatory markers, urea kinetics, protein catabolic rateBimonthly

Secondary

MeasureTime frame
Fat levels by skin fold measurementsOnce monthly
Handgrip strength by dynamometerOnce monthly
Six minute walk test distanceOnce monthly
Maximal Oxygen Consumption (VO2 max) and Heart Rate Recovery through Queens College step testOnce Monthly
Depression (Beck Depression Questionnaire)Once monthly
Lactate ThresholdOnce monthly
Quality of life (KDQOL - SF questionnaire)Once monthly

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026