The Effects of a Mobile-Application Based Physical Activity Intervention in PLWH

NCT04993820 | Unknown

• 1 other identifier: 2021-0494
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

A series of adverse physical and mental health effects are often reported among people living with HIV (PLWH) as a consequence of the infection and ART use. Physical activity (PA) has been linked to improved physical an mental health in PLWH. However, Most interventions in the HIV literature evaluating the effects of PA on physical and mental health have included face-to-face supervised exercise in highly controlled environments which is not representative of how the majority of this population engages in PA. Mobile application (app) and text-message based PA interventions are a safe and innovative approach for the delivery of PA programs aimed at improving physical and mental health without the need of direct supervision. Nonetheless, the use of these types of interventions have not been well evaluated in PLWH. Therefore the purpose of this study is to evaluate the effects of a 12-week mobile app and text-based PA intervention on physical and mental health in PLWH. Participants in the PA group will be given a PA program delivered through a mobile health app which will be accessed through smartphones. As part of the program, weekly text messages will be sent to encourage PA participation. The goal of the intervention is to increase moderate to vigorous PA (MVPA) by at least 150 weekly/mins. The PA program will also include muscle strengthening exercises. Investigators expect improvements in mental health outcomes (i.e., depressive symptoms and HRQoL) and cardiometabolic outcomes (i.e., cardio-autonomic function, body fat percentage, physical activity, and functional exercise capacity) in the PA group when compared to the CON group at the end of 12-weeks.

Conditions

HIV

Keywords

Physical Activity; RCT

Outcome Measures

Primary Outcomes (1)

• Physical Activity (PA)

  Minutes of moderate to vigorous PA per week using an Actigraph triaxial accelerometer (Model GT9X) worn at the wrist. This will be done to evaluate for changes in free-living PA as a result of the intervention

  7 consecutive days before the start of the intervention and 7 consecutive days during the last week of the intervention

Secondary Outcomes (7)

• Body fat percentage

  12 weeks

• Fat free mass

  12 weeks

• Cardio-autonomic function

  12 weeks

• Functional exercise capacity

  12 weeks

• Depression symptoms

  12 weeks

Study Arms (2)

Physical Activity (PA)

EXPERIMENTAL

Combination of aerobic exercise and muscle strengthening exercise.

Behavioral: Physical activity

Education Control (CON)

ACTIVE COMPARATOR

No exercise group.

Behavioral: Education control

Interventions

Physical activity BEHAVIORAL

The goal for week one will be to increase moderate-to-vigorous PA (MVPA) by 90 weekly/mins, and by 120 weekly/mins on week two. This amount of time will provide the participant with an adaptation period. The goal for weeks 3-12 will be to increase MVPA by at least 150 weekly/mins. The prescribed aerobic activities can be performed either: 1) outdoors (e.g., walking or cycling), 2) at home (e.g., in-place jogging, dancing, aerobics), or 3) with available exercise equipment if the participant already has this access. Participants will perform a series of 6 to 8 muscle strengthening (MS) exercises for the major muscle groups using elastic bands and their own bodyweight 3 times per week. All MS activities will be depicted in instructional videos available through the app. Participants will be asked to perform 2 sets of 8 to 12 repetitions (reps) per exercise during weeks 1-3, 3 sets of 8 to 12 reps per exercise during weeks 3-7, and 4 sets of 8 to 12 reps per exercise during weeks 8-12.

Physical Activity (PA)

Education control BEHAVIORAL

Participants in the education CON group will be asked to perform their usual activities and to not engage in additional PA during the intervention. Participants will receive weekly brochures and reading materials including topics related to living with HIV, healthy eating, stress management, and current Federal PA guidelines for Americans. The brochures and reading materials will be available through the BluejayEngage health web-based platform app.

Education Control (CON)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) diagnosed with HIV,
• \) receiving the same ART for at least six months,
• \) being clinically stable (i.e., no recent AIDS-defining opportunistic infections, a CD4+ T-cell count ≥ 200 cells·mm-3, and asymptomatic),
• \) owning a smartphone with text message capabilities, and
• \) willing to receive four or more text messages per week.

You may not qualify if:

• \) having a diabetes mellitus diagnosis
• \) requiring the use of an assistive device for walking as it will impair physical activity,
• \) participating in any sport or planned exercise program on more than two days per week
• \) having any signs or symptoms of CVD or any known uncontrolled cardiovascular, pulmonary or neuromuscular disease that may preclude exercise participation,
• \) severe arthritis, hip or knee fracture or spinal surgery in the past 6 months
• \) having any contraindications to exercise as identified by the American College of Sports Medicine

Sponsors & Collaborators

• Queens College, The City University of New York: lead
• City University of New York: collaborator

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Norberto Quiles, Ed.D.

  Queens College of The City University of New York

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Norberto Quiles, Ed.D.

CONTACT

718-997-2718; Norberto.Quilesgonzalez@qc.cuny.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to either a physical activity group oran education control group for the the length of the intervention (12 weeks).

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: August 6, 2021
• Study Start: August 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share