Chronic Kidney Disease Among Frail Elderly

NCT02351349 | Completed Results

• 1 other identifier: 14-275-GEN
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

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

Outcome Measures

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.

  6 months

Secondary Outcomes (5)

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

  6 months

• Hospitalizations

  6 months

• Physical Functioning Measures

  12 weeks

• Time up and go

  12 weeks

• Dominant Hand Grip

  12 weeks

Study Arms (2)

multidisciplinary intervention

EXPERIMENTAL

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

Non adherence

NO INTERVENTION

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

Interventions

multidisciplinary intervention OTHER

multidisciplinary intervention

Also known as: physiotherapy, nutritional therapy, supportive therapy

multidisciplinary intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sameena Iqbal: lead

Study Sites (1)

McGill UNiversity Health Center

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Frailty

Interventions

Physical Therapy Modalities; Nutrition Therapy; Palliative Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Patient Care; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Sameena Iqbal
• Organization: MUHC

sameena.iqbal@mcgill.ca

5146302225

Study Officials

• Sameena Iqbal, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: January 30, 2015
• Study Start: January 1, 2016
• Primary Completion: December 15, 2016
• Study Completion: December 15, 2016
• Last Updated: May 26, 2021
• Results First Posted: May 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)