Home-based Interventions for FrAilty preveNTion in AdultS With DIabeTes and Chronic Kidney Disease

NCT05527574 | Completed

• 1 other identifier: Pro00089513
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

One of the most common problems in people with diabetes (DM) and chronic kidney disease (CKD) is the high frequency of other coinciding medical conditions such as osteoporosis and frailty. Frailty in particular is very common in adults with DM and CKD and it can result in significant muscle weakness which can result in increasing difficulties with performing activities of daily life (ADL). This can lead to an increase risk for falls, bone fractures and increasing hospitalization. The investigators have showed that adults with DM and CKD who have frailty use hospital services more frequently, have reduced quality of life and difficulties with performing their ADLs1. There is some evidence that early screening for frailty and lifestyle interventions that focus on healthier eating and physical activity can help prevent frailty from getting worse. The study purpose is to develop and test a home-based lifestyle intervention program focused on optimizing diet and the ability to perform your ADLs in adults with DM and CKD. The goal of this program is to ensure that adults with DM can live healthier lives within the community.

Conditions

Diabetes Type 2; Frailty; Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Changes in frailty status in response to the exercise intervention

  Changes in frailty status (Edmonton Frailty Scoring System) in response to the home-based rehabilitation protocol vs standard of care over six months. Values in the Edmonton Frailty Scale range from 0-18 ; where values 0-5 are non-frail, 6-7 apparently frail vulnerable, 8-9 mild frailty, 10-11 moderately frail and 12-18 severely frail.

  Six months

Secondary Outcomes (3)

• Changes in total skeletal muscle mass surface area in response to exercise intervention

  Six months

• Changes in health related quality of life (HRQOL)

  Six months

• Changes in cognitive health

  Six months

Study Arms (4)

Exercise Intervention Frail

EXPERIMENTAL

Resistance Exercise Intervention (home video education: resistance training and diet education) for Frail participants

Other: Resistance Exercise

Standard of Care or Control Frail

NO INTERVENTION

Standard of Care (standard diet and physical activity education) for Frail Participants

Exercise Intervention Pre-Frail

EXPERIMENTAL

Resistance Exercise Intervention (home video education: resistance training and diet education) for Pre-Frail participants

Other: Resistance Exercise

Standard of Care or Control Pre-Frail

NO INTERVENTION

Standard of Care (standard diet and physical activity education) for Pre-Frail Participants

Interventions

Resistance Exercise OTHER

Participants are enrolled in 30-40 minutes of resistance exercise training using elastic bands for 30-40 minutes/session three times per week over six months

Exercise Intervention Frail; Exercise Intervention Pre-Frail

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (50-85 years)
• Clinically Diagnosed with diabetes (Type 2) and stage 1-IV CKD (Glomerular Filtration - Rate (GFR) 10-89 ml/min/1.73m2).

You may not qualify if:

• Functional and cognitive impairments (MMSE scores\<24)
• Severe, permanent vision loss.
• Recent history of bone fracture in the last 12 months
• History of skeletal muscular disorders which precludes the ability to perform resistance exercises (e.g., moderate to severe osteoarthritis that prevents walking, bending and/or sit to stand or wheelchair dependent)
• Pregnant women
• Dialysis (hemodialysis or peritoneal dialysis) as treatment of kidney disease

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Diabetic Nephropathy Prevention Clinic - Alberta Kidney Care - North

Edmonton, Alberta, T6L 5X8, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Frailty; Kidney Diseases

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Diana Mager, PhD MSc RD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: September 2, 2022
• Study Start: November 30, 2019
• Primary Completion: December 29, 2025
• Study Completion: December 30, 2025
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

CA (1)