Trial Outcomes & Findings for Exercise to Prevent Muscle Mass and Functional Loss in Elderly Dialysis Patients (NCT NCT01990495)

NCT ID: NCT01990495

Last Updated: 2021-01-25

Results Overview

The overall primary outcome for the study is maximal oxygen uptake. Maximal oxygen uptake is the amount of oxygen consumed by the body during maximal exercise. It is the gold standard expression for exercise capacity.

Recruitment status

COMPLETED

Study phase

Target enrollment

37 participants

Primary outcome timeframe

3 months

Results posted on

2021-01-25

Participant Flow

Participant milestones

Participant milestones
Measure	Exercise The study involves two arms randomized to exercise and usual care groups Exercise training: Subjects will participate in a center-based and home exercise training program for 3 months. Usual Care: This group will serve as control subjects. They will receive only usual clinical care.	Usual Care This group will be randomized to receive usual clinical care. No other interventions will be assigned to this group. Usual Care: This group will serve as control subjects. They will receive only usual clinical care.
Overall Study STARTED	18	19
Overall Study COMPLETED	13	15
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Exercise The study involves two arms randomized to exercise and usual care groups Exercise training: Subjects will participate in a center-based and home exercise training program for 3 months. Usual Care: This group will serve as control subjects. They will receive only usual clinical care.	Usual Care This group will be randomized to receive usual clinical care. No other interventions will be assigned to this group. Usual Care: This group will serve as control subjects. They will receive only usual clinical care.
Overall Study Physician Decision	5	4

Baseline Characteristics

Exercise to Prevent Muscle Mass and Functional Loss in Elderly Dialysis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exercise n=13 Participants Subjects will participate in a center-based and home exercise training program for 3 months.	Usual Care n=15 Participants This group will be randomized to receive usual clinical care. No other interventions will be assigned to this group.	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Age, Continuous	66.3 years STANDARD_DEVIATION 7.6 • n=5 Participants	66.2 years STANDARD_DEVIATION 6.7 • n=7 Participants	66.3 years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Chronic kidney disease

Outcome measures

Outcome measures
Measure	Exercise n=13 Participants Subjects will participate in a center-based and home exercise training program for 3 months.	Usual Care n=15 Participants This group will be randomized to receive usual clinical care. No other interventions will be assigned to this group.
Maximal Oxygen Uptake	14.5 ml/kg/min Standard Deviation 3.3	15.1 ml/kg/min Standard Deviation 3.3

SECONDARY outcome

Timeframe: 3 Months

Population: Maintenance hemodialysis (\>3 months)

The biopsy procedures will permit the measurement of the percentage of type 1 fibers in the quadriceps muscle. The biopsy procedures will also be used to quantify protein signaling, a measure of the capacity of the muscle to gain or lose muscle mass.

Outcome measures

Outcome measures
Measure	Exercise n=13 Participants Subjects will participate in a center-based and home exercise training program for 3 months.	Usual Care n=15 Participants This group will be randomized to receive usual clinical care. No other interventions will be assigned to this group.
Biopsy of the Quadriceps Muscle.	33.2 Percentage of type 1 fibers Standard Deviation 11	30.0 Percentage of type 1 fibers Standard Deviation 9

SECONDARY outcome

Timeframe: 3 months

Population: Chronic kidney disease on maintenance hemodialysis.

Disease-specific quality of life instrument is used to quantify broad quality of life domains, including physical function. Higher scores mean better values using a 0-100 scale.

Outcome measures

Outcome measures
Measure	Exercise n=13 Participants Subjects will participate in a center-based and home exercise training program for 3 months.	Usual Care n=15 Participants This group will be randomized to receive usual clinical care. No other interventions will be assigned to this group.
Quality of Life Score	48.7 score on a scale Standard Deviation 25.6	60.0 score on a scale Standard Deviation 22.3

Adverse Events

Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jonathan Myers

VA Palo Alto Health Care System

Phone: 6504503440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place