Exercise and Monitoring With Post-Hospitalization Muscle Atrophy to Sustain Intrinsic Capacity and Strength

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorVA Office of Research and Development

About this trial

The aging Veteran population has more frequent inpatient hospitalization than non-Veterans. In addition, older Veterans have an inability to fully recover muscle mass and function after hospital-acquired weakness. The problem of hospital-acquired weakness is greatly increased in at-risk Veteran populations such as those with chronic kidney disease (CKD). The purpose of this collaborative study involving Denver and Baltimore VAMC sites is to improve health through the detection and rehabilitation management of hospital-acquired weakness in those with CKD. The study goals include identifying and monitoring the optimal muscle assessment sites in clinical settings, examining how muscle health impacts length of hospital stay and physical resilience, and determining how home-based and supervised exercise comparatively addresses post-hospitalization physical resilience using performance tests and Veteran feedback.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 55 years

Diagnosis of stage 3-4 CKD or an eGFR of <45 mL/min/1.73m2

Disqualifiers

Cardiovascular risk: Poorly controlled hypertension (>160/100)

Coronary event in past 6 months

Class III or IV CHF

symptomatic angina at rest or during exercise

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise

    Other intervention

    The participants will exercise 2 days a week for 16 weeks. The exercises will include 4 movements: squats, shoulder press, seated row, and bicep curl focusing on internal load and contraction velocity.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: ExerciseExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Vastus Lateralis Muscle Thickness

A measure of the Vastus Lateralis muscle will be examined using ultrasound technology to determine the muscle size, quality, and composition. Post-intervention levels will be compared to 6 months after the cessation of the intervention.

Time frame
4 month, 10 month
2

Function

The short physical performance battery test is a function measure that utilizes 3 tasks scores 0-4 (total possible score of 12) to determine functional status and lower extremity function. Pre-test scores will be compared to post intervention test scores.

Time frame
4 month, 10 month
3

Lower Extremity Strength - Isometric Strength

A measures of maximal isometric muscle strength produced in knee extensor muscles will be assessed with a Biodex device. Post-intervention levels will be compared to 6 months after the cessation of exercise.

Time frame
4 month, 10 month
4

Upper Extremity Strength - Grip Strength

A measures of maximal isometric muscle strength produced in upper extremity muscles will be assessed by grip strength. Post-intervention levels will be compared to 6 months after the cessation of exercise.

Time frame
4 month, 10 month

Secondary outcomes

1

Rectus Femoris Muscle Thickness

A measure of the Rectus Femoris muscle will be examined using ultrasound technology to determine the muscle size, quality, and composition. Post-intervention levels will be compared to 6 months after the cessation of the intervention.

Time frame
4 month, 10 month
2

Bicep Brachii Muscle Thickness

A measure of the Bicep Brachii muscle will be examined using ultrasound technology to determine the muscle size, quality, and composition. Post-intervention levels will be compared to 6 months after the cessation of the intervention.

Time frame
4 month, 10 month
3

Middle Deltoid Muscle Thickness

A measure of the Middle Deltoid muscle will be examined using ultrasound technology to determine the muscle size, quality, and composition. Post-intervention levels will be compared to 6 months after the cessation of the intervention.

Time frame
4 month, 10 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.