Health TrialsbyHealthPanel

Physical Activity Modifies Exercise Responsiveness

ConditionMultimorbidity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorVA Office of Research and Development

About this trial

Exercise is the cornerstone of rehabilitation and an essential part of treatment plans for many chronic conditions; however, our understanding of why certain individuals respond positively to exercise while others do not remains incomplete. Physical inactivity and sedentary behavior have reached epidemic levels, coinciding with alarmingly high levels of multimorbidity in Veterans that, the investigators believe, impair exercise responsiveness and rehabilitation efficacy by disrupting the regulation of redox homeostasis and redox signaling by the transcription factor Nrf2 (nuclear factor erythroid 2-related factor 2). This project will use complementary approaches including 1) the Sit Less, Interact, Move More (SLIMM) intervention, and 2) PB125 to target Nrf2 and break the cycle of sedentary behavior, redox stress, functional impairments, and worsening multimorbidity in older Veterans.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Physically inactive, ≤5,000 steps/day

Multimorbidity Weighted Index between 6 to 11

Ability to sign informed consent

Montreal cognitive assessment (MOCA) exam score ≥26

Disqualifiers

Multimorbidity Weighted Index < 6 or > 11

Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma

Currently on a weight-loss diet or body mass index (BMI) > 35 kilograms per square meter (kg/m2) (a BMI of 35 kg/m2, which includes individuals that fall into to the Class I obesity category, has been selected to improve inclusion and generalizability to a greater percentage of the general population)

Human immunodeficiency virus (HIV) or hepatitis B or C

Trial design

Design model

Sequential

Treatments tested in this trial

  • SLIMM - Sit less, interact, move more

    Behavioral

    To minimize sedentary behavior and increase physical activity the investigators will use our SLIMM intervention. The goal of SLIMM is to replace 1 hour/day of sedentary duration with casual walking time. This goal is \~10% of the average baseline sedentary duration of 10.8 hours/day. While SLIMM is not anchored to a fixed percentage or step count increase, it operationalizes this goal through behavioral coaching and activity monitoring focused on increasing stepping time throughout the day. The SLIMM target duration for decreasing sedentary duration by 1 hour/day is based upon potential impact on energy expenditures and mortality from our previous National Health and Nutrition Examination Survey (NHANES) publication on sedentary behavior in patients with multimorbidity.

  • PB125

    Dietary supplement

    The novel naturally derived activator of Nrf2, PB125, contains extracts from three botanical sources including i) Rosmarinus officinalis, standardized to carnosol content of 6%, 68 milligrams (mg) of extract; ii) Withania somnifera (aka Ashwagandha), standardized to withaferin A content of 1%, 23 milligrams (mg) of extract; and iii) Sophora Japonica, standardized to luteolin content of 98%, 9 milligrams (mg) of extract. Each extract can increase the nuclear translocation of Nrf2 and when combined, these extracts act in synergy through multiple control points to amplify and prolong the activation of Nrf2.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: SLIMM Phase 1Experimental treatment 1 intervention
Group B: PB125/Placebo Phase 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Vascular function

Measured by flow-mediated dilation. Percent dilation (% FMD) from baseline to peak vasodilation. Measured by Doppler Ultrasound.

Time frame
pre and post 12 and 24 weeks of intervention
2

Muscle Strength

Isokinetic knee extensor muscle strength.

Time frame
pre and post 12 and 24 weeks of intervention
3

Physical Activity

Steps per day.

Time frame
pre and post 12 and 24 weeks of intervention
4

Sedentary Behavior

Time spent sedentary measured in hours/day.

Time frame
pre and post 12 and 24 weeks of intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

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

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: