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CompletedNCT02351349FRED-CKDUpdated May 26, 2021Results posted

Chronic Kidney Disease Among Frail Elderly

An interventional study of multidisciplinary intervention in Chronic Kidney Disease, sponsored by Sameena Iqbal. Completed at 1 site in Canada. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2021-05-26.

Sponsored by Sameena Iqbal · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Non-randomized
Ages
65 Years and older
Sex
All
01

Study summary

Chronic kidney disease is a common diagnosis in the elderly population and it is associated with significant morbidity and health care costs. The prevalence rates increase with age to about 40% for adults aged > 65 years. In the elderly population (age 65 and over), CKD is associated with a higher burden of comorbid conditions and frailty. The prevalence of frailty is higher in CKD patients with rated being double in early stages and nearly 6 times higher beyond stage 3b. Previously reported frailty mortality rates of 18% at 3 years and 47% at 7 years comparing with mortality rates in non frail individuals of 3% and 12% respectively. In this study, the investigators investigate the effect of multidisciplinary interventions upon frail elderly patients with CKD not yet on dialysis. This interventions include best medical care, nutrition, physiotherapy, and social, psychological and spiritual support.

Read the detailed description

A multilevel, multidisciplinary intervention is required to assist frail CKD patients given the complexity of their condition. However, the optimal methods for this intervention are not very well defined in the literature.

It was previously described that dialysis does not improve (and often times can worsen) the outcomes of frail patients with renal disease (41). The nowadays trend is to try to optimise and decrease frailty before initiation of dialysis. If that is not possible, a more conservative and palliative approach is envisaged. Regardless, a combined geriatric and nephrological expertise may help to identify patients at high risk of early death for whom this approach is indicated (42).

Major medical societies have regularly reviewed and published their guidelines for medical management of chronic kidney disease. Most reputable such guidelines are KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (43) and The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF KDOQI, (44)). In Canada, field experts reviewed current evidence and provided similar recommendations (45). In summary, all this guidelines provide expert opinion on treatment and targets of treatment in CKD patients with an accent on controlling cardiovascular risk factors (hypertension, diabetes, dyslipidemia), lifestyle management, control of CKD complications (proteinuria, anemia, mineral metabolism), and initiation of renal replacement therapy.

Lifestyle management is probably one of the most important intervention in CKD population. First and foremost, it empowers the patients to take control of their lives and become an active partner in their treatment. Smoking cessation, weight reduction, dietary protein control, alcohol intake, exercise, and controlling salt intake are proven to improve outcomes and are part of current guidelines. Regular physical exercise improves physical fitness, walking capacity, cardiovascular parameters (e.g. blood pressure and heart rate), health-related quality of life, and nutritional parameters (48). Physical activity is also protective against depression (49). In the case of frail patients, usually sedentary, with multiple cardiac risk factors, it is recommended to begin with gradual exercise and under supervision.

Nutrition must be targeted in the frail elderly with CKD because decreasing energy intake is associated with higher stages of CKD (50). Though in the CKD non dialysis population, nutrition supplementation has not been formally assessed, the general population of frail elderlies have been evaluated with protein supplementation.

Tieland et al (51) randomized 65 frail elderly in protein versus placebo supplementation groups for 24 weeks. January 11, 2015 revised The protein supplementation group had no benefit with respect to weight gain or muscle strength. However, when resistive exercise training was coupled with protein supplementation, body weight gain was achieved.

Furthermore, Tieland et al (52) randomized 62 frail elderly in two groups, both who received exercise training but only one group received protein supplements. A 0.7 kg weight gain was recorded in the protein supplement but none in the control group. The sustainability and the benefit in survival of such weight gain has not been determined, especially in the CKD non dialysis patients. Thus, the investigators propose that exercise with protein supplementation will benefit the CKD frail older population.

Frail patients with or without CKD are at risk of experiencing psychological distress. Acknowledging one's own limitations, inability to perform up to certain social standards, losing function when comparing with friends or family members within same age group, depending on other's support can all be envisage as high risk factors for depression and/or other psychological ailments. Psychological distress is associated decrease quality of life of worse outcomes. Anxiety and depression are 2 major compounds of psychological distress. Patients can be screened with two easy to use scales: GAD-7 (for anxiety) and PHQ-9 (for depression). Were identified, these conditions should be treated by Psychiatry or Geriatrics services.

Disability is best assessed using the standard ten variables addressed in the Barthel scale (56) are: presence or absence of fecal incontinence, presence or absence of urinary incontinence, help needed with grooming, help needed with toilet use, help needed with feeding, help needed with transfers (e.g. from chair to bed), help needed with walking, help needed with dressing, help needed with climbing stairs, and help needed with bathing. The Maryland State Medical Society holds the copyright for the Barthel Index. It may be used freely for noncommercial purposes with the following citation: Mahoney FI, Barthel D. "Functional evaluation: the Barthel Index." Maryland State Med Journal 1965;14:56-61. The scale is detailed in Appendix 2 and it is used with permission.

Interventions targeted to improve frailty are limited by the patient's ability to collaborate and work with the treating team. Severe cognitive impaired patients lack insight and capacity and they are limited in their capacity to rehabilitated. MoCA (57) is a well validated tool at identifying cognitive impairment, it is widely available in many languages, and it is recommended by The Canadian Consensus Guidelines for Diagnosis and Treatment of Dementia for detection of Mild Cognitive Impairment and Alzheimer's disease. A cut-off of > 17 is generally used to exclude severe dementia. A language specific MoCA and instructions to administer the test are available online at http://www.mocatest.org/. The original English version is reproduced in Appendix 3.

The primary objective of the proposed study is to assess the effect of intensive multidisciplinary interventions on survival, hospitalization and need to start dialysis. Secondary objectives include the assessment of the intervention in different stages of sarcopenia and measurement of physical functioning and nutritional parameters to evaluate the effect of such interventions among the frail CKD population.

02

Conditions studied

  • Chronic Kidney Disease

Keywords

  • frailty
  • CKD
  • Physical Therapy Modalities
  • Elder Nutritional Physiological Phenomena
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 14 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Sameena Iqbal is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Eligible participants must be ≥65 years as of December 2014, with estimated glomerular filtration rate (eGFR) of ≤30ml/min, and experiencing frailty defined as 3 out of 5 criterias: unintentional weight loss (self-reported or January 11, 2015 revised objective 10 lbs in past year)
  • Self-reported exhaustion
  • Weakness (measured by grip strength)
  • Slow walking speed (measured by the 6 minute walking test)
  • Low physical activity.

Exclusion criteria

Exclusion Criteria:

  • Exclusion criteria are: persons aged \<65
  • Unable to grasp dynamometer due to various reasons
  • Expected life expectancy \<6 months due to a non-renal cause
  • Patient refusal to participate
  • Plan to travel or transfer treatment site during study period and unable to be contacted
  • Severe cognitive impairment (as screened with MoCA \<18).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    multidisciplinary intervention

    Due to the problem of randomization, the study became a before and after assessment in the one group that completed the 12 week exercise program and received nutritional support

    Other: multidisciplinary intervention

  • No intervention
    Non adherence

    Those who were offered the program but did not complete the prescription

Interventions

  • Othermultidisciplinary intervention

    multidisciplinary intervention

    Also known as: physiotherapy, nutritional therapy, supportive therapy

06

What researchers measure

Primary outcomes

  1. Mortality

    the entire sample will be followed until time of death or until study completed. The cause of death will be determined from proxies or from hospital records.

    Time frame: 6 months

Secondary outcomes

  1. Number of Patients Progressed to the Need for Renal Replacement Therapy (Any Modality or Palliation).

    Number of patients progressed to the need for renal replacement therapy (any modality or palliation).

    Time frame: 6 months

  2. Hospitalizations

    information about principal diagnosis, number and length of hospitalizations will be collected at 6-month intervals from participant, from proxies

    Time frame: 6 months

  3. Physical Functioning Measures

    assessed by applying the data of the 4 meter walk compared between the two study groups.

    Time frame: 12 weeks

  4. Time up and go

    one of the physical functioning parameters

    Time frame: 12 weeks

  5. Dominant Hand Grip

    right hand grip average of three values

    Time frame: 12 weeks

07

Results

Posted May 26, 2021

Participant flow

For recruitment 14 were consented 5 patients dropped out -- 3 started hemodialysis the first week of starting the study and 2 due to medical illness and desire not to follow up with testing

Participant flow — Overall Study
MilestoneIntervention: Multi InterventionControl
Started68
Completed45
Not completed23
Withdrew: Withdrawal by subject23

Outcome measures

PrimaryMortality

the entire sample will be followed until time of death or until study completed. The cause of death will be determined from proxies or from hospital records.

Time frame:
6 months
Reported as:
Number · percentage of mortality
Mortality
percentage of mortalityIntervention: Multi InterventionControl
Mortality00
SecondaryNumber of Patients Progressed to the Need for Renal Replacement Therapy (Any Modality or Palliation).

Number of patients progressed to the need for renal replacement therapy (any modality or palliation).

Time frame:
6 months
Reported as:
Count of participants · Participants
Number of Patients Progressed to the Need for Renal Replacement Therapy (Any Modality or Palliation).
ParticipantsIntervention: Multi InterventionControl
Number of Patients Progressed to the Need for Renal Replacement Therapy (Any Modality or Palliation).00
SecondaryHospitalizations

information about principal diagnosis, number and length of hospitalizations will be collected at 6-month intervals from participant, from proxies

Time frame:
6 months
Reported as:
Number · participants
Hospitalizations
participantsIntervention: Multi InterventionControl
Hospitalizations00
SecondaryPhysical Functioning Measures

assessed by applying the data of the 4 meter walk compared between the two study groups.

Time frame:
12 weeks
Reported as:
Median · seconds
Physical Functioning Measures
secondsIntervention: Multi InterventionControl
baseline 4 m walk5 (3.3 to 7.0)5.3 (4.3 to 5.8)
4m walk at 12 weeks3.9 (2.6 to 6.0)5.5 (4.2 to 6.2)
Statistical analysis
  • Intervention: Multi Intervention · t-test, 2 sided · p = 0.0143
SecondaryTime up and go

one of the physical functioning parameters

Time frame:
12 weeks
Reported as:
Median · seconds
Time up and go
secondsMultidisciplinary InterventionControl
baseline12 (8.6 to 17.5)13 (11.1 to 14.4)
12 weeks10.8 (6.9 to 15.8)13.3 (11.3 to 15.5)
Statistical analysis
  • Multidisciplinary Intervention · t-test, 2 sided · p = 0.1416
SecondaryDominant Hand Grip

right hand grip average of three values

Time frame:
12 weeks
Reported as:
Median · kg
Dominant Hand Grip
kgMultidisciplinary InterventionControl
baseline23 (14 to 35)19 (16 to 23)
12 weeks26.5 (14 to 39)20 (16 to 28)
Statistical analysis
  • Multidisciplinary Intervention · t-test, 2 sided · p = 0.9013

Adverse events

Collected over The adverse event happened at the time of randomization in the first three months. There was break in randomization technique. The functional outcome testing was only completed at 12 weeks. No testing was done at 24 weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention: Multi Intervention0/4 (0%)0/4 (0%)0/4 (0%)
Control0/5 (0%)0/5 (0%)0/5 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Multidisciplinary InterventionControlTotal
Age76.5 (69 to 91)78 (68 to 85)78 (68 to 91)
Sex: Female, Male
Sex: Female, Male(Participants)Multidisciplinary InterventionControlTotal
Female224
Male235
Weight
Weight(kilograms)Multidisciplinary InterventionControlTotal
Median67 (60 to 104)74 (66 to 102)73 (60 to 104)
height
height(meters)Multidisciplinary InterventionControlTotal
Median1.64 (1.52 to 1.79)1.63 (1.47 to 1.79)1.63 (1.47 to 1.79)
Body mass index
Body mass index(kg/m^2)Multidisciplinary InterventionControlTotal
Median27.2 (21.7 to 32.25)29.2 (23.1 to 38.8)28.2 (21.7 to 38.8)
estimated GFR
estimated GFR(ml/min/1.73m^2)Multidisciplinary InterventionControlTotal
Median32 (26 to 39)17 (13 to 47)31 (13 to 47)
08

Study locations

1 site
  • McGill UNiversity Health Center
    Montreal, Quebec, Canada
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02351349
Lead sponsor
Sameena Iqbal
Responsible party
Sameena Iqbal (Assistant professor, McGill University Health Centre/Research Institute of the McGill University Health Centre) — Sponsor-investigator
First posted
Jan 30, 2015
Start date
Jan 2016
Primary completion
Dec 15, 2016
Completion
Dec 15, 2016
Results posted
May 26, 2021
Last update
May 26, 2021

Study contacts

Sameena Iqbal, MD
principal investigator · McGill University Health Centre/Research Institute of the McGill University Health Centre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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