跳至主要内容
临床试验/NCT05295797
NCT05295797Unknown不适用

The Positively Dance Pilot Program: Examining the Feasibility of a Peer Research Associate-Led Dance Program for Women Living With HIV

University of British Columbia1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Acceptability and feasibility of the selected procedures (e.g. blood draws, questionnaires) by determining numbers who attend these sessions and complete the questionnaires

研究概览

简要总结

The Positively Dance study involves the assessment of the accessibility and feasibility of a 12-week randomized aerobic dance pilot program that will provide women living with HIV with the opportunity to take part in dance classes with women living with HIV as the dance instructors.

详细描述

Women living with HIV (WLWH) are at greater risk of advanced cellular aging, comorbidities, and early mortality than men living with HIV or women in the general population. WLWH face significant social and economic disadvantages which serve as barriers to accessing HIV therapy or other programming that could support their health and wellbeing. It is thus critical to identify amenable healthy aging factors to ameliorate the burden of HIV for WLWH.

Aerobic training has consistently been shown to reduce disease risk and early mortality in the general population and in people living with HIV. Immune system function partly underlies many of the cardiovascular, lung, muscular, and neural benefits of aerobic exercise. While sporadic immune activation is typical during innate and adaptive immune responses, the development and pathogenesis of non-communicable diseases are now understood to result from chronic, low-grade, systemic inflammation in the body, known as inflamm-aging as seen among people living with HIV even when their viremia is controlled by therapy. Systemic inflammation results from multiple sources, including, but not limited to, accumulation of fat and immunosenescent cells, the latter of which no longer divide but secrete damaging inflammatory cytokines. Immunosenescent cells are marked by several biomarkers, though most attention has been directed towards average telomere lengths of immune cells. Telomeres are genepoor regions located at the ends of chromosomes and are formed by hexameric 5'(TTAGGG) n3' repeats and shortened telomeres portend earlier replicative senescence - when cells no longer replicate but live on in a pro-inflammatory state - or programmed cellular death. 24 weeks of physical activity is associated with apparent reversal of the aging process of immune cells with increases in average leukocyte (i.e. immune cells) telomere lengths (LTL).

While aerobic exercise benefits people living with HIV, a recent review emphasizes that WLWH and adults from minority groups are less likely to engage in or are more likely to withdraw from standard exercise programs. Consultations with The Canadian HIV Sexual and Reproductive Health Cohort Study (CHIWOS) Advisory Board of WLWH identified and prioritized the need for interventional research to mitigate the effects of accelerated aging and decrease the risk of disease, and identified dance as a particularly exciting program to study, if made free and easily accessible.

This study will be a 12-week randomized dance pilot program. The dance classes will be led by trained peer dance instructors who are also WLHIV.

Prior to consent, participants will be screened for inclusion/exclusion criteria. Next, participants will be invited to an in-person, paid orientation session to review study objectives and discuss the pros/cons to participating in the pilot program and randomization to either a waitlist control or active study arm. After consent, participants will then be asked to complete blood draws and a pre-intervention survey.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Self-identify as women living with HIV
  • •Are over the age of 18
  • •Are able to speak and read English
  • •Are able and willing to commit to participating in dance classes 2 times a week per week for 12 weeks
  • •Be able to attend in person dance classes
  • •Meet minimal risk clearance to engage in exercise (screened with the Physical Activity Readiness Questionnaire PARQ+)

排除标准

  • •Do not self-identify as a woman living with HIV
  • •Are under the age of 18
  • •Cannot speak and read English
  • •Cannot attend in person dance classes
  • •Do not meet minimal risk clearance to engage in exercise (screened with the Physical Activity Readiness Questionnaire PARQ+)

研究组 & 干预措施

Dance Program

Experimental

Participants will take 2 in person dance classes led by peer dance instructors per week for 12 weeks

干预措施: Dance Program (Behavioral)

Control

No Intervention

Participants in the waitlist control will be assigned to a waiting list and will be invited to participate in dance classes after the intervention arm 12-week dance program has ended

结局指标

主要结局

Acceptability and feasibility of the selected procedures (e.g. blood draws, questionnaires) by determining numbers who attend these sessions and complete the questionnaires

时间窗: Baseline (Week 0) and at the end of the program (Week 13)

This information will be used to understand feasibility and acceptability

Adverse events that may occur during the trial

时间窗: Week 1-24

This information will be used to understand feasibility

Proportion of women who accept the invitation to participate in the research study

时间窗: Throughout the recruitment phase, up to 1.5 months

This information will be used to understand feasibility

Number of women who initially participate in the intervention

时间窗: Week 1-12

This information will be used to understand feasibility

Proportion of women who participate in the dance classes, even after the active data collection phase is completed

时间窗: Week 13-24

To determine the extent to which women continue attending the dance classes for an additional 12 weeks, if the classes are offered for free. This information will be used to understand feasibility.

Continued participation of the peer dance instructors

时间窗: Week 1-24

This information will be used to understand feasibility

Individual semi-structured interviews asking participants their perceptions of and experiences with the program

时间窗: Once after Week 12, up to 4 weeks after

To determine the accessibility and feasibility of the intervention, we will conduct individual semi-structured qualitative interviews with the participants who took part in the intervention arm of the study as well as with the peer dance instructors. The women will be asked about their perceptions of and experiences with the program, including why they joined the program, what they liked and disliked about the program, what the program meant to them, how effective they thought the program had been, what barriers to participation they faced throughout the intervention, and their suggestions for future program delivery. Interviews will occur via Zoom or in-person depending on the participant's preferences and will be audio-recorded (only the audio portion of the interviews will be recorded).

次要结局

  • Changes in general physical and mental health measured with the 36-Item Short Form Survey(Baseline (Week 0) and at the end of the program (Week 13))
  • Changes in social cohesion measured with the Social Assurance Scale(Baseline (Week 0) and at the end of the program (Week 13))
  • Changes in C-Reactive Protein(Baseline (Week 0) and at the end of the program (Week 13))
  • Changes in whole blood telomere length(Baseline (Week 0) and at the end of the program (Week 13))
  • Changes in HbA1c(Baseline (Week 0) and at the end of the program (Week 13))
  • Changes in social connectedness measured with the Social Connectedness Scale(Baseline (Week 0) and at the end of the program (Week 13))
  • Changes in depressive symptoms measured with the Patient Health Questionnaire-9(Baseline (Week 0) and at the end of the program (Week 13))
  • Changes in social support measured with the MOS Social Support Scale(Baseline (Week 0) and at the end of the program (Week 13))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eli Puterman

Associate Professor

University of British Columbia

研究点 (1)

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