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An Intensive Lifestyle Intervention Program in CKD (Move to Health 2) (MTHL2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02842957
Recruitment Status : Unknown
Verified October 2017 by Samuel A. Headley, Springfield College.
Recruitment status was:  Active, not recruiting
First Posted : July 25, 2016
Last Update Posted : October 13, 2017
Relypsa, Inc.
Information provided by (Responsible Party):
Samuel A. Headley, Springfield College

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.

Condition or disease Intervention/treatment Phase
Kidney Disease Behavioral: Lifestyle Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Intensive Lifestyle Intervention Program in CKD (Move to Health 2)
Study Start Date : July 2016
Estimated Primary Completion Date : December 2, 2017
Estimated Study Completion Date : December 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Lifestyle intervention
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
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.

No Intervention: Usual Care
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

Primary Outcome Measures :
  1. Physical Function Measure [ Time Frame: 6 month intervention ]
    Short Physical Performance Battery

Secondary Outcome Measures :
  1. KDQOL-SF [ Time Frame: 6 months ]
    The KDQOL-36™ is a short form that includes the SF-12 as generic core supplemented with multi-item scales targeted at particular concerns of individuals with kidney disease (i.e. the burden of kidney disease, symptoms/problems of kidney disease, and effects of kidney disease scales on daily life).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02842957

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United States, Massachusetts
Springfield College
Springfield, Massachusetts, United States, 01109
Sponsors and Collaborators
Springfield College
Relypsa, Inc.
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Responsible Party: Samuel A. Headley, Professor of Exercise Science, Springfield College Identifier: NCT02842957    
Other Study ID Numbers: Move to Health 2
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases