An Intensive Lifestyle Intervention Program in CKD (Move to Health 2)

Completed · Not applicable

Conditions studied: Kidney Disease

In brief

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.

Key facts

Study ID

NCT02842957

Run by

Springfield College

People needed

42

Starts

2016-07-01

Expected to finish

2017-04-08

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• Springfield College — Springfield, Massachusetts, United States

Full record on ClinicalTrials.gov

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