DialysisPhase 2DIAPRENCT01065389
Resistance Training in Intradialysis Patients
A Phase 2 study testing Progressive Resistance Exercise Training and Unstructured Nonprogressive resistance exercise in people with Dialysis and End Stage Renal Disease, run by Sikkim Manipal University at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Dialysis, End Stage Renal Disease
- What is being tested?
- Progressive Resistance Exercise Training and Unstructured Nonprogressive resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2010to Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 RCT of Progressive Resistance Training on Small Solute Clearance, Functional Capacity and Quality of Life in Intradialysis Patients
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.
Read the 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
- Conditions
- Dialysis, End Stage Renal Disease
- Being tested
- Progressive Resistance Exercise Training, Unstructured Nonprogressive resistance exercise
- Keywords
- Intradialysis, Resistance training, Protein Catabolic Rate, Urea kinetics, Quality of life, VO2 max
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Resistance Exercise TrainingBehavioural
Also called Strength Training
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
Unstructured Nonprogressive resistance exerciseBehavioural
Also called Non progressive strength training
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.
| Study group | Role | What they receive |
|---|---|---|
| Prgressive Resistance Exercise Training | Experimental | 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 Receives: Behavioral: Progressive Resistance Exercise Training |
| Unstructured Resistance Exercise | Active comparator | Unstructured Resistance Exercise 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. Receives: Behavioral: Unstructured Nonprogressive resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum and Urea biochemistry - electrolytes (Na, K+), serum albumin, inflammatory markers, urea kinetics, protein catabolic rate
Measured: Bimonthly
Secondary outcomes (7)
Maximal Oxygen Consumption (VO2 max) and Heart Rate Recovery through Queens College step test
Measured: Once Monthly
Fat levels by skin fold measurements
Measured: Once monthly
Handgrip strength by dynamometer
Measured: Once monthly
Six minute walk test distance
Measured: Once monthly
Quality of life (KDQOL - SF questionnaire)
Measured: Once monthly
Depression (Beck Depression Questionnaire)
Measured: Once monthly
Lactate Threshold
Measured: Once monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startOct 2010
- Primary completionApr 2015 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sikkim Manipal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr. Baskaran Chandrasekaran, Sikkim Manipal University
- Investigators
- Baskaran Chandrasekaran, MPT, Principal investigator, Lecturer / Consultant cardiopulmonary PhysiotherapistBidhan C Sharma, MPT, Study chair, Assistant Professor/ Consultant PhysiotherapistManish Goon, BPT, Study chair, Clinical PhysiotherapistNikita Joshi, MPT, Study chair, Head of Department/ Associate ProfessorArpan Battacharia, MD, Study chair, Dialysis Unit InchargeBidita Kandelwal, MD, Study director, Head of Medicine Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065389
- Sponsor's protocol ID
- CTRI/2010/091/000014
- Acronym
- DIAPRE
- Status last verified
- Sep 2013
- First submitted
- 4 Feb 2010
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 RCT of Progressive Resistance Training on Small Solute Clearance, Functional Capacity and Quality of Life in Intradialysis Patients
- ClinicalTrials.gov ID
- NCT01065389
- Acronym / sponsor ID
- DIAPRE / CTRI/2010/091/000014
- Conditions
- Dialysis, End Stage Renal Disease
- Keywords
- Intradialysis, Resistance training, Protein Catabolic Rate, Urea kinetics, Quality of life, VO2 max
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Sikkim Manipal UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 9 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prgressive Resistance Exercise Training | Experimental | Behavioral: Progressive Resistance Exercise TrainingProgressive 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 |
| Unstructured Resistance Exercise | Active comparator | Behavioral: Unstructured Nonprogressive resistance exerciseUnstructured Resistance Exercise 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Resistance Exercise TrainingAlso: Strength TrainingProgressive 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 | Behavioural | Prgressive Resistance Exercise Training |
| Unstructured Nonprogressive resistance exerciseAlso: Non progressive strength trainingUnstructured 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. | Behavioural | Unstructured Resistance Exercise |
Primary outcome
Serum and Urea biochemistry - electrolytes (Na, K+), serum albumin, inflammatory markers, urea kinetics, protein catabolic rate
Time frame: Bimonthly
7 secondary outcomes
Maximal Oxygen Consumption (VO2 max) and Heart Rate Recovery through Queens College step test
Time frame: Once Monthly
Fat levels by skin fold measurements
Time frame: Once monthly
Handgrip strength by dynamometer
Time frame: Once monthly
Six minute walk test distance
Time frame: Once monthly
Quality of life (KDQOL - SF questionnaire)
Time frame: Once monthly
Depression (Beck Depression Questionnaire)
Time frame: Once monthly
Lactate Threshold
Time frame: Once monthly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baskaran Chandrasekaran, MPT principal investigator
Lecturer / Consultant cardiopulmonary Physiotherapist
Bidhan C Sharma, MPT study chair
Assistant Professor/ Consultant Physiotherapist
Manish Goon, BPT study chair
Clinical Physiotherapist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Progressive Resistance Exercise Training and Unstructured Nonprogressive resistance exercise in people with Dialysis and End Stage Renal Disease, run by Sikkim Manipal University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum and Urea biochemistry - electrolytes (Na, K+), serum albumin, inflammatory markers, urea kinetics, protein catabolic rate (time frame: Bimonthly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2013.