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Behavioral Interventions for Older Adults with HIV (HiActivity Trial)
N/A
Recruiting
Led By Lisa Uebelacker, PhD
Research Sponsored by Butler Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 4
Awards & highlights
HiActivity Trial Summary
This trial will examine 3 interventions to increase physical activity in older HIV+ adults. Outcome is steps/day & results will guide choice of components for an optimized behavioral intervention.
Who is the study for?
This trial is for older adults over 50 living with HIV who are physically able to walk without help, speak English, and use a Fitbit app. They must be on antiretroviral therapy for at least 3 months and do less than 90 minutes of moderate exercise weekly. Participants need medical clearance if they have heart issues or experience chest pain.Check my eligibility
What is being tested?
The study tests three methods to boost physical activity: coaching sessions, cognitive behavioral therapy to tackle barriers like low motivation or pain, and a social support system using Fitbit. The main goal is to increase the number of steps taken each day by participants.See study design
What are the potential side effects?
Since this trial focuses on behavior changes rather than medication, side effects may include typical exercise-related discomforts such as muscle soreness or fatigue but will vary based on individual health conditions.
HiActivity Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Steps per day
Secondary outcome measures
CVD Risk
Emotional Well-being
Frailty Phenotype
+4 moreHiActivity Trial Design
8Treatment groups
Experimental Treatment
Group I: BASM + SS-PAExperimental Treatment2 Interventions
Brief Advice and Self-Monitoring Social support for Physical Activity
Group II: BASM + PA Coaching + SS-PAExperimental Treatment3 Interventions
Brief Advice and Self-Monitoring Physical Activity Coaching Social support for Physical Activity
Group III: BASM + PA Coaching + CB-PA + SS-PAExperimental Treatment4 Interventions
Brief Advice and Self-Monitoring Physical Activity Coaching Cognitive-Behavioral Intervention to Increase Physical Activity Social support for Physical Activity
Group IV: BASM + PA Coaching + CB-PAExperimental Treatment3 Interventions
Brief Advice and Self-Monitoring Physical Activity Coaching Cognitive-Behavioral Intervention to Increase Physical Activity
Group V: BASM + PA CoachingExperimental Treatment2 Interventions
Brief Advice and Self-Monitoring Physical Activity Coaching
Group VI: BASM + CB-PA + SS-PAExperimental Treatment3 Interventions
Brief Advice and Self-Monitoring Cognitive-Behavioral Intervention to Increase Physical Activity Social support for Physical Activity
Group VII: BASM + CB-PAExperimental Treatment2 Interventions
Brief Advice and Self-Monitoring Cognitive-Behavioral Intervention to Increase Physical Activity
Group VIII: BASMExperimental Treatment1 Intervention
Brief Advice and Self-Monitoring
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Physical Activity Coaching
2017
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Butler HospitalLead Sponsor
129 Previous Clinical Trials
16,210 Total Patients Enrolled
Lisa Uebelacker, PhDPrincipal InvestigatorButler Hospital
9 Previous Clinical Trials
960 Total Patients Enrolled
Jason Baker, MDPrincipal InvestigatorHennepin Healthcare
1 Previous Clinical Trials
37 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any health issues that prevent me from being active or participating in a study.I have been on continuous HIV medication for more than 3 months.I can walk on my own without any help from devices.I understand the study details and can repeat them back correctly.I am 50 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: BASM + PA Coaching + CB-PA
- Group 2: BASM + CB-PA
- Group 3: BASM + CB-PA + SS-PA
- Group 4: BASM
- Group 5: BASM + PA Coaching
- Group 6: BASM + SS-PA
- Group 7: BASM + PA Coaching + CB-PA + SS-PA
- Group 8: BASM + PA Coaching + SS-PA
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment open for this research endeavor?
"Clinicaltrials.gov records show that this clinical trial is currently in search of participants. It was first made available on June 21st 2023 and its details were last revised on July 14th 2023."
Answered by AI
How many participants are currently taking part in this medical research?
"Affirmative. The clinical trial is recruiting, according to the information available on clinicaltrials.gov. It was initially posted June 21st 2023 and has been updated July 14th 2023; 208 patients are needed from 1 single site for participation in this study."
Answered by AI
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