NCT02842957

Brief Summary

The primary purpose of the current 6-month study is to determine the effect of an integrated, comprehensive, individualized, intervention program including dietary, exercise, pharmacy, and behavioral counseling on patient performance of the short physical performance battery (SPPB) which gives an indication of an individual's ability to perform activities of daily living dependent upon lower extremity function. Additional objectives include the impact of the intervention on cardiovascular risk factors, and the impact of the intervention on other indices of physical function in stage 3-4 CKD patients. The investigators hypothesize that patients who participate in this integrated, intensive, individualized lifestyle intervention will have higher SPPB scores compared to individuals in the usual care group. The investigators also hypothesize that this approach will lead to higher adherence rates to the lifestyle recommendations and that those who adhere will also show better improvements in the measured variables over time compared to patients who are randomly assigned to the usual care group or who comply poorly with the various study components.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2017

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

July 18, 2016

Last Update Submit

April 21, 2026

Conditions

Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Physical Function Measure

    Short Physical Performance Battery

    6 month intervention

Secondary Outcomes (1)

  • KDQOL-SF

    6 months

Study Arms (2)

Lifestyle intervention

EXPERIMENTAL

Behavioral: The Lifestyle arm is the experimental group that will be exposed to an intensive, individualized approach aimed at assisting these CKD patients to adhere to lifestyle changes that are expected to be beneficial to their health and wellbeing. Patients will receive direction to implement a plant based diet, along with more physical activity in their lives. They will be assisted with the optimal use of their prescribed medications by pharmacy professionals and they will receive behavioral counseling by experts in that area.

Behavioral: Lifestyle Intervention

Usual Care

NO INTERVENTION

The Usual Care arm will continue to receive the current standard of care involving all the services provided at a contemporary nephrology practice in Western Massachusetts

Interventions

Lifestyle InterventionBEHAVIORAL

Patients randomized to the lifestyle group will be given individual counseling regarding the implementation of a plant based diet. They will also be given a home based exercise program to complete. Patients will be assisted with the optimal use of their prescription medications and they will receive specific counseling regarding strategies to help them successfully change their behavior.

Lifestyle intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be stage 3-4 of CKD (GFR 15-59 ml/min/1.73m2)
  • Must be between the ages of 18-75 years old,
  • Must be capable of complying with and following the study protocol(diet and exercise)
  • Must be capable of independently giving informed consent

You may not qualify if:

  • if the patient is currently on Veltassa
  • if in an exercise program,
  • if the patient suffers from severe constipation,
  • if they have bowel obstruction
  • if they have impaction
  • if the patient has post-operative motility disorders (i.e., GI disorders).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Springfield College

Springfield, Massachusetts, 01109, United States

Location

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Exercise Science

Study Record Dates

First Submitted

July 18, 2016

First Posted

July 25, 2016

Study Start

July 1, 2016

Primary Completion

April 8, 2017

Study Completion

April 8, 2017

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations

US(1)