Physical Activity Program for Sedentary Lifestyle

Recruiting in Palo Alto (17 mi)

Overseen by Dori E Rosenberg, PhD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Kaiser Permanente

Disqualifiers: Cancer, Heart attack, Arrhythmia, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

In this randomized controlled trial, study staff will randomize 130 Hispanic/Latino adults without dementia and over age 55 from Southern California and from Kaiser Permanente Washington (State) to either the culturally adapted De Pie physical activity intervention or an active comparison program focusing on general brain health topics. The purpose of this study is to determine if 12 weeks of the culturally adapted and fully remote De Pie y a Movernos intervention improves self-efficacy, habit strength, social support, and enjoyment for physical activity (PA), thus promoting adherence to moderate-intensity physical activity (MIPA) guidelines (150 minutes/week).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on physical activity, so it's likely you can continue your medications, but you should confirm with the study team.

What data supports the effectiveness of the treatment De Pie Intervention, De Pie y a Movernos for a sedentary lifestyle?

Research shows that using a pedometer (a device that counts steps) in physical activity programs can help people become more active and reduce the time they spend sitting. This approach has been effective in improving physical activity levels and quality of life in people with conditions like COPD and diabetes. ^{1 2 3 4 5}

Is the Physical Activity Program for Sedentary Lifestyle safe for participants?

Research shows that physical activity programs, like the ones similar to the Physical Activity Program for Sedentary Lifestyle, are generally safe for humans. While minor injuries, mostly related to muscles and joints, can occur, no serious adverse events have been reported. It's important to start slowly and gradually increase activity levels. ^{6 7 8 9 10}

How is the De Pie Intervention treatment different from other treatments for a sedentary lifestyle?

The De Pie Intervention is unique because it focuses on a physical activity program specifically designed to address sedentary lifestyles, potentially incorporating educational and motivational components to encourage regular movement, unlike other treatments that may focus more on dietary changes or general health advice. ^{11 12 13 14 15}

Research Team

Zvinka Z Zlatar, PhD

Principal Investigator

University of California, San Diego

Dori E Rosenberg, PhD, MPH

Principal Investigator

Kaiser Permanente

Eligibility Criteria

This trial is for Hispanic/Latino adults over age 55 living in Southern California who do not have dementia. Participants should be leading a sedentary lifestyle and are interested in increasing their physical activity to meet moderate-intensity guidelines.

Inclusion Criteria

Willing to follow study procedures depending on program assignment

I am available for calls on weekdays from 8am to 5pm.

Able to participate for up to 20 weeks in the study

Exclusion Criteria

Unable to hear phone conversation, even with a hearing aid

Had a fall in the last year that resulted in hospitalization

I am willing to get an email address if I don't already have one.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the culturally adapted De Pie y a Movernos intervention or the HALT-AD active comparison program for 12 weeks

12 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for changes in physical activity and psychosocial mediators after the intervention

4 weeks

Treatment Details

Interventions

• De Pie Intervention (Behavioral Intervention)

Trial Overview The study compares two programs: the De Pie intervention, which encourages physical activity, and HALT-AD, focusing on brain health education. The goal is to see if De Pie can boost self-efficacy and enjoyment of exercise over a period of 12 weeks.

Participant Groups

Group I: De Pie Intervention Experimental Treatment 1 Intervention

The De Pie intervention program receives a sedentary behavior reduction and physical activity promotion intervention centered on two steps: Step 1) reduce sitting time and move more throughout the day; Step 2) if cleared by a safety assessment and blood pressure check, participants can work towards adding structured bouts of exercise into their day.

Group II: HALT-AD Active Comparison Group Active Control 1 Intervention

Those randomized to HALT-AD (Healthy Actions and Lifestyles to Avoid Dementia) will receive one phone call to introduce them to preventing cognitive decline through various lifestyle behaviors (e.g. stress reduction, healthy diet, healthy sleep) other than physical activity. They will be encouraged by the Health Coach upon randomization to complete one module approximately every week (there are 10 modules in total).

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Greg A. Adams

Kaiser Permanente

Chief Executive Officer since 2019

MBA from University of Southern California

Dr. Edward M. Ellison

Kaiser Permanente

Chief Medical Officer since 2015

MD from Harvard Medical School

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Dr. Christopher Longhurst

University of California, San Diego

Chief Medical Officer since 2021

MD and MS in Medical Informatics from UC Davis

Patty Maysent

University of California, San Diego

Chief Executive Officer since 2016

MBA from Stanford University

Findings from Research

In a study involving 327 patients with COPD, both a pedometer-based behavioral intervention group and a control group showed significant increases in daily steps and improvements in quality of life six weeks and six months after a three-week inpatient pulmonary rehabilitation program.

However, the addition of the pedometer intervention did not lead to statistically significant greater increases in physical activity levels compared to the control group, indicating that standard rehabilitation alone was effective in enhancing activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Benefits of Adding a Pedometer to Pulmonary Rehabilitation for COPD: The Randomized Controlled STAR Trial. Geidl, W., Carl, J., Schuler, M., et al.[2021]

In a randomized trial with 204 participants, those who increased their physical activity (iPA) managed to exercise 14 more minutes per day and reduced their sedentary behavior by 18 minutes per day, showing a clear link between increased activity and decreased sitting time.

Participants who focused on reducing sedentary leisure time (dSED) did not show significant changes in physical activity or sedentary behavior, indicating that actively increasing exercise may be more effective than simply trying to cut down on screen time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Changes in Physical Activity on Sedentary Behavior: Results From a Randomized Lifestyle Intervention Trial. Siddique, J., de Chavez, PJ., Craft, LL., et al.[2018]

The study involves 239 Veterans with chronic obstructive pulmonary disease (COPD) participating in a randomized controlled trial to test the effectiveness of an Internet-mediated walking program called Taking Healthy Steps, which aims to increase physical activity and improve health outcomes.

Participants in the intervention group receive personalized feedback and support through a pedometer and online community, while the control group waits a year for their intervention, highlighting the potential for remote programs to engage older Veterans with significant health challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taking Healthy Steps: rationale, design and baseline characteristics of a randomized trial of a pedometer-based Internet-mediated walking program in veterans with chronic obstructive pulmonary disease. Martinez, CH., Moy, ML., Nguyen, HQ., et al.[2022]

In a study involving 21 COPD patients, those who received lifestyle physical activity counseling and used a pedometer increased their daily steps by 1,430 steps/day (69% increase), compared to a 455 steps/day (19% increase) in the control group, suggesting that the intervention may enhance physical activity levels.

While the primary outcome of increased daily steps was significant, secondary outcomes such as physical fitness and quality of life did not show notable differences, indicating that while the intervention is effective for increasing activity, it may not directly improve other health metrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a lifestyle physical activity counseling program with feedback of a pedometer during pulmonary rehabilitation in patients with COPD: a pilot study. de Blok, BM., de Greef, MH., ten Hacken, NH., et al.[2012]

In a randomized controlled trial involving 209 elderly participants (average age 80), a home-based exercise program was found to be generally safe, with 151 adverse events reported, affecting 47% of participants.

Despite the program's safety, 14% of the adverse events were serious, highlighting that high levels of pre-existing morbidity in this population can pose challenges to maintaining consistent exercise participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. Hinrichs, T., Bücker, B., Wilm, S., et al.[2015]

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

In a 1.5-year study involving 274 male veterans with cardiovascular disease risk factors, only one serious adverse event (atrial fibrillation) occurred, indicating that a progressive walking program can be safely recommended for high-risk individuals.

While minor musculoskeletal issues were common, over half of the reported adverse events were unrelated to the exercise program, highlighting the need for strategies to help individuals with chronic illnesses safely resume physical activity after any health setbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. Goodrich, DE., Larkin, AR., Lowery, JC., et al.[2022]

Researchers in resistance training studies often lack clear guidance and motivation for thorough adverse event (AE) reporting, which can lead to inconsistent practices.

There is a need for exercise-specific guidelines for AE reporting, as current standards are perceived as not applicable to exercise trials, highlighting the importance of tailored strategies to improve reporting consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2022]

A systematic review of 773 studies involving over 38,000 participants found that exercise therapy does not increase the risk of serious adverse events, indicating it is a safe intervention.

However, exercise therapy was associated with a higher risk of non-serious adverse events, with a relative risk of 1.19, meaning that for every 6 participants, one additional non-serious adverse event may occur.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis. Niemeijer, A., Lund, H., Stafne, SN., et al.[2022]

An educational program focused on physical activity significantly improved habitual physical activity levels and self-efficacy in patients after their first percutaneous coronary intervention, compared to usual care, in a study involving 109 participants.

The program's effectiveness was measured 5 to 7 months post-discharge, showing a mean score increase of 0.89 for physical activity and 2.30 for self-efficacy, with no significant differences in anxiety and depression symptoms between the groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an educational program on physical activity in individuals undergoing their first percutaneous coronary intervention: A randomized clinical trial. Pitta, NC., Furuya, RK., Freitas, NO., et al.[2023]

The Dietary Advice program by the Andalusian Health Department aims to combat diseases linked to sedentary lifestyles and poor eating habits through a structured two-phase approach, focusing on both individual and group interventions.

The intensive dietary phase includes personalized nurse visits and workshops designed to equip participants with the knowledge and skills necessary to adopt healthier lifestyles, potentially reducing the risk of major diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intensive dietary advice program in primary care]. Sánchez-Robles, R., Gea-Lázaro, ML.[2012]

The EdAl-2 educational intervention program successfully increased after-school physical activity among boys, with a 15% higher participation rate in the intervention group compared to controls, but did not lead to changes in obesity prevalence or BMI after 22 months.

While the program improved some lifestyle habits, such as reducing screen time for boys, it did not have a significant impact on overall obesity rates or BMI in the participating children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EdAl-2 (Educació en Alimentació) programme: reproducibility of a cluster randomised, interventional, primary-school-based study to induce healthier lifestyle activities in children. Llauradó, E., Tarro, L., Moriña, D., et al.[2021]

In a study of 427 octogenarians in long-term care, replacing sedentary behavior with light-intensity or moderate to vigorous physical activity significantly improved various measures of physical function, including strength and mobility.

Participants who engaged in more physical activity showed notable increases in chair stand cycles, peak force, grip strength, and faster times in mobility tests, highlighting the importance of physical activity for enhancing the quality of life in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Replacing Sedentary Behavior With Physical Activity of Different Intensities: Implications for Physical Function, Muscle Function, and Disability in Octogenarians Living in Long-Term Care Facilities. Del Pozo-Cruz, J., Irazusta, J., Rodriguez-Larrad, A., et al.[2022]

The 'Sigue la Huella' program effectively increased moderate to vigorous physical activity levels and reduced sedentary time among secondary education students in Huesca, Spain, involving 368 students in the experimental group and 314 in the control group over a 25-month period.

The intervention utilized a holistic approach based on the social-ecological model and self-determination theory, empowering students to take an active role in their physical activity, which contributed to its success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of the 'Sigue la Huella' physical activity intervention for adolescents in Huesca, Spain. Murillo Pardo, B., Julián Clemente, JA., García González, L., et al.[2020]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Long-Term Benefits of Adding a Pedometer to Pulmonary Rehabilitation for COPD: The Randomized Controlled STAR Trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

The Effect of Changes in Physical Activity on Sedentary Behavior: Results From a Randomized Lifestyle Intervention Trial. [2018]

3. Ireland pubmed.ncbi.nlm.nih.gov

The effects of a pedometer-based behavioral modification program with telephone support on physical activity and sedentary behavior in type 2 diabetes patients. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Taking Healthy Steps: rationale, design and baseline characteristics of a randomized trial of a pedometer-based Internet-mediated walking program in veterans with chronic obstructive pulmonary disease. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

The effects of a lifestyle physical activity counseling program with feedback of a pedometer during pulmonary rehabilitation in patients with COPD: a pilot study. [2012]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis. [2022]

11. Brazil pubmed.ncbi.nlm.nih.gov

Effect of an educational program on physical activity in individuals undergoing their first percutaneous coronary intervention: A randomized clinical trial. [2023]

12. Spain pubmed.ncbi.nlm.nih.gov

[Intensive dietary advice program in primary care]. [2012]

13. England pubmed.ncbi.nlm.nih.gov

EdAl-2 (Educació en Alimentació) programme: reproducibility of a cluster randomised, interventional, primary-school-based study to induce healthier lifestyle activities in children. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Replacing Sedentary Behavior With Physical Activity of Different Intensities: Implications for Physical Function, Muscle Function, and Disability in Octogenarians Living in Long-Term Care Facilities. [2022]

15. England pubmed.ncbi.nlm.nih.gov

Development of the 'Sigue la Huella' physical activity intervention for adolescents in Huesca, Spain. [2020]