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Chronic Kidney Disease Among Frail Elderly

MULTIDISCIPLINARY INTERVENTION FOR FRAIL ELDERLY PATIENTS WITH STAGE 4 or 5 Chronic Kidney Disease (Not on Dialysis)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02351349
Acronym
FRED-CKD
Enrollment
14
Registered
2015-01-30
Start date
2016-01-31
Completion date
2016-12-15
Last updated
2021-05-26

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

Conditions

Chronic Kidney Disease

Keywords

frailty, CKD, Physical Therapy Modalities, Elder Nutritional Physiological Phenomena

Brief 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.

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.

Interventions

multidisciplinary intervention

Sponsors

Sameena Iqbal
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

allocated intervention to those who were willing to complete the exercise program due to the difficulty for recruitment, this study was changed to a feasibility study

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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

*

Design outcomes

Primary

MeasureTime frameDescription
Mortality6 monthsthe 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.

Secondary

MeasureTime frameDescription
Number of Patients Progressed to the Need for Renal Replacement Therapy (Any Modality or Palliation).6 monthsNumber of patients progressed to the need for renal replacement therapy (any modality or palliation).
Hospitalizations6 monthsinformation about principal diagnosis, number and length of hospitalizations will be collected at 6-month intervals from participant, from proxies
Physical Functioning Measures12 weeksassessed by applying the data of the 4 meter walk compared between the two study groups.
Time up and go12 weeksone of the physical functioning parameters
Dominant Hand Grip12 weeksright hand grip average of three values

Countries

Canada

Participant flow

Recruitment details

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

Participants by arm

ArmCount
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 multidisciplinary intervention: multidisciplinary intervention
4
Control
Those who were offered the program but did not complete the prescription
5
Total9

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject23

Baseline characteristics

CharacteristicControlTotalMultidisciplinary Intervention
Age, Continuous
Age
78 years78 years76.5 years
Body mass index29.2 kg/m^228.2 kg/m^227.2 kg/m^2
estimated GFR17 ml/min/1.73m^231 ml/min/1.73m^232 ml/min/1.73m^2
height1.63 meters1.63 meters1.64 meters
Sex: Female, Male
Female
2 Participants4 Participants2 Participants
Sex: Female, Male
Male
3 Participants5 Participants2 Participants
Weight74 kilograms73 kilograms67 kilograms

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 40 / 5
other
Total, other adverse events
0 / 40 / 5
serious
Total, serious adverse events
0 / 40 / 5

Outcome results

Primary

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

Population: mortality

ArmMeasureValue (NUMBER)
Intervention: Multi InterventionMortality0 percentage of mortality
ControlMortality0 percentage of mortality
Secondary

Dominant Hand Grip

right hand grip average of three values

Time frame: 12 weeks

Population: paired t test

ArmMeasureGroupValue (MEDIAN)
Intervention: Multi InterventionDominant Hand Gripbaseline23 kg
Intervention: Multi InterventionDominant Hand Grip12 weeks26.5 kg
ControlDominant Hand Grip12 weeks20 kg
ControlDominant Hand Gripbaseline19 kg
Comparison: pre and post value comparison with paired t test was carried outp-value: 0.9013t-test, 2 sided
Secondary

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

Population: no hospitalizations recorded in either arm

ArmMeasureValue (NUMBER)
Intervention: Multi InterventionHospitalizations0 participants
ControlHospitalizations0 participants
Secondary

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

Population: three individuals started hemodialysis within 1 week of randomization, they were excluded

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention: Multi InterventionNumber of Patients Progressed to the Need for Renal Replacement Therapy (Any Modality or Palliation).0 Participants
ControlNumber of Patients Progressed to the Need for Renal Replacement Therapy (Any Modality or Palliation).0 Participants
Secondary

Physical Functioning Measures

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

Time frame: 12 weeks

Population: data on 4m walk, time up and go, dominant hand grip

ArmMeasureGroupValue (MEDIAN)
Intervention: Multi InterventionPhysical Functioning Measuresbaseline 4 m walk5 seconds
Intervention: Multi InterventionPhysical Functioning Measures4m walk at 12 weeks3.9 seconds
ControlPhysical Functioning Measuresbaseline 4 m walk5.3 seconds
ControlPhysical Functioning Measures4m walk at 12 weeks5.5 seconds
p-value: 0.0143t-test, 2 sided
Secondary

Time up and go

one of the physical functioning parameters

Time frame: 12 weeks

Population: time up and go

ArmMeasureGroupValue (MEDIAN)
Intervention: Multi InterventionTime up and gobaseline12 seconds
Intervention: Multi InterventionTime up and go12 weeks10.8 seconds
ControlTime up and gobaseline13 seconds
ControlTime up and go12 weeks13.3 seconds
Comparison: pre and post comparison of time up and go in intervention groupp-value: 0.1416t-test, 2 sided

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