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Human Immunodeficiency VirusDanceNCT05295797

The Positively Dance Pilot Program for Women Living With HIV

A study testing Dance Program in people with Human Immunodeficiency Virus, run by University of British Columbia at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Human Immunodeficiency Virus
What is being tested?
Dance Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
1 May 2022to 1 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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+)

Who cannot join

  • 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+)

Trial locations and contacts

1 site in 1 country.

Eli Puterman, PhD contact

604 822 2854

eli.puterman@ubc.ca

Canada1 site, 1 recruiting

  • University of British Columbia

    Vancouver, British Columbia, V6T1Z4

    Eli Puterman, PhD, 604 822 2854, eli.puterman@ubc.ca

    Recruiting

Other trials in Canada

About this study

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

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.

Read the detailed description

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.

Each dance instructor (PRA) will lead 1-2 classes (50-min/class) per week (depending on availability) for 12 weeks, with an expectation that women in the pilot's active arm have access to 2 classes per week during the first 12 weeks of active data collection. Classes will be offered in person at a local dance studio. Attendance will be taken at each dance class by throughout the 12 weeks. Participants will also have the opportunity to socialize during breaks after dance classes for as long as they wish for up to half an hour.

Following the 12 weeks of active data collection for the pilot program, all participating women will be asked to return to complete blood draws and a repeat survey to collect post-intervention data on physical activity levels, mental and physical health, and social integration. We will also conduct semi-structured interviews with all women in the active arm to learn more about their experiences in and impressions of the program.

Our 12-week program will be followed by 12 more weeks of dance classes where waitlist women are invited to join the classes. Attendance of all women will be tracked.

Being tested
Dance Program
Keywords
HIV, dance, peer-led
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dance ProgramBehavioural

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

Study groups in NCT05295797
Study groupRoleWhat they receive
Dance ProgramExperimentalParticipants will take 2 in person dance classes led by peer dance instructors per week for 12 weeks
Receives: Behavioral: Dance Program
ControlNo interventionParticipants 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    This information will be used to understand feasibility

    Measured: Throughout the recruitment phase, up to 1.5 months

  2. Number of women who initially participate in the intervention

    This information will be used to understand feasibility

    Measured: Week 1-12

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

    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.

    Measured: Week 13-24

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

    This information will be used to understand feasibility and acceptability

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

  5. Adverse events that may occur during the trial

    This information will be used to understand feasibility

    Measured: Week 1-24

  6. Continued participation of the peer dance instructors

    This information will be used to understand feasibility

    Measured: Week 1-24

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

    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).

    Measured: Once after Week 12, up to 4 weeks after

Secondary outcomes (8)

  1. Changes in whole blood telomere length

    Whole blood telomere length, using the standard approach of measuring relative telomere lengths with quantitative polymerase chain reaction.

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

  2. Changes in depressive symptoms measured with the Patient Health Questionnaire-9

    The Patient Health Questionnaire-9 (PHQ) is the self-administered depression module of the full Patient Health Questionnaire. It scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day).

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

  3. Changes in general physical and mental health measured with the 36-Item Short Form Survey

    The 36-Item Short Form Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures relying on self-reporting. Likert scales and yes/no options are used to assess function and well-being on this 36-item questionnaire.

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

  4. Changes in social support measured with the MOS Social Support Scale

    The MOS Social Support Survey measures four dimensions of functional social support. It is a 19-item multidimensional, self-administered instrument. Questions are answered on a five-point scale ranging from "none of the time" to "all of the time," with higher values indicating more support.

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

  5. Changes in social connectedness measured with the Social Connectedness Scale

    This scale assesses the degree to which individuals feel connected to others in their social environment. Items are scored from 1 (strongly disagree) to 6 (strongly agree). Items are summed and a higher score indicates more connectedness to others.

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

  6. Changes in social cohesion measured with the Social Assurance Scale

    The Social Assurance Scale is a 6 point Likert scale. Items are added up for a total score, and a higher score indicates more connectedness to others.

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

  7. Changes in HbA1c

    Information will be used to determine means and standard deviations for these traditional health markers

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

  8. Changes in C-Reactive Protein

    Information will be used to determine means and standard deviations for these traditional health markers.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2022
  2. Study start1 May 2022
  3. Primary completion1 Jul 2023 (estimated)
  4. Study completion1 Sep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Thirty WLWH will be enrolled and randomized to the (1) group-based 12-week dance program (N=15) or (2) waitlist control (N=15) (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).
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05295797
Sponsor's protocol ID
H20-03483
Acronym
Dance
Status last verified
May 2023
First submitted
2 Mar 2022
Last updated
11 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Burchell AN, Raboud J, Donelle J, Loutfy MR, Rourke SB, Rogers T, Rosenes R, Liddy C, Kendall CE. Cause-specific mortality among HIV-infected people in Ontario, 1995-2014: a population-based retrospective cohort study. CMAJ Open. 2019 Jan 8;7(1):E1-E7. doi: 10.9778/cmajo.20180159. Print 2019 Jan-Mar.

    PubMed 30622108

  • Hogg RS, Eyawo O, Collins AB, Zhang W, Jabbari S, Hull MW, Lima VD, Ahmed T, Kendall CE, Althoff KN, Justice AC, Barrios R, Shoveller J, Montaner JSG; Comparative Outcomes And Service Utilization Trends (COAST) study. Health-adjusted life expectancy in HIV-positive and HIV-negative men and women in British Columbia, Canada: a population-based observational cohort study. Lancet HIV. 2017 Jun;4(6):e270-e276. doi: 10.1016/S2352-3018(17)30029-2. Epub 2017 Mar 3.

    PubMed 28262574

  • Scully EP. Sex Differences in HIV Infection. Curr HIV/AIDS Rep. 2018 Apr;15(2):136-146. doi: 10.1007/s11904-018-0383-2.

    PubMed 29504062

  • Kendall CE, Wong J, Taljaard M, Glazier RH, Hogg W, Younger J, Manuel DG. A cross-sectional, population-based study measuring comorbidity among people living with HIV in Ontario. BMC Public Health. 2014 Feb 13;14:161. doi: 10.1186/1471-2458-14-161.

    PubMed 24524286

  • Patterson S, Cescon A, Samji H, Chan K, Zhang W, Raboud J, Burchell AN, Cooper C, Klein MB, Rourke SB, Loutfy MR, Machouf N, Montaner JS, Tsoukas C, Hogg RS; CANOC collaboration. Life expectancy of HIV-positive individuals on combination antiretroviral therapy in Canada. BMC Infect Dis. 2015 Jul 17;15:274. doi: 10.1186/s12879-015-0969-x.

    PubMed 26183704

  • Heissel A, Zech P, Rapp MA, Schuch FB, Lawrence JB, Kangas M, Heinzel S. Effects of exercise on depression and anxiety in persons living with HIV: A meta-analysis. J Psychosom Res. 2019 Nov;126:109823. doi: 10.1016/j.jpsychores.2019.109823. Epub 2019 Sep 2.

    PubMed 31518734

  • Pedersen BK, Saltin B. Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015 Dec;25 Suppl 3:1-72. doi: 10.1111/sms.12581.

    PubMed 26606383

  • O'Brien KK, Tynan AM, Nixon SA, Glazier RH. Effectiveness of aerobic exercise for adults living with HIV: systematic review and meta-analysis using the Cochrane Collaboration protocol. BMC Infect Dis. 2016 Apr 26;16:182. doi: 10.1186/s12879-016-1478-2.

    PubMed 27112335

  • Franceschi C, Garagnani P, Parini P, Giuliani C, Santoro A. Inflammaging: a new immune-metabolic viewpoint for age-related diseases. Nat Rev Endocrinol. 2018 Oct;14(10):576-590. doi: 10.1038/s41574-018-0059-4.

    PubMed 30046148

  • De Francesco D, Wit FW, Burkle A, Oehlke S, Kootstra NA, Winston A, Franceschi C, Garagnani P, Pirazzini C, Libert C, Grune T, Weber D, Jansen EHJM, Sabin CA, Reiss P; the Co-morBidity in Relation to AIDS (COBRA) Collaboration. Do people living with HIV experience greater age advancement than their HIV-negative counterparts? AIDS. 2019 Feb 1;33(2):259-268. doi: 10.1097/QAD.0000000000002063.

    PubMed 30325781

  • Keating SM, Golub ET, Nowicki M, Young M, Anastos K, Crystal H, Cohen MH, Zhang J, Greenblatt RM, Desai S, Wu S, Landay AL, Gange SJ, Norris PJ; Women's Interagency HIV Study. The effect of HIV infection and HAART on inflammatory biomarkers in a population-based cohort of women. AIDS. 2011 Sep 24;25(15):1823-32. doi: 10.1097/QAD.0b013e3283489d1f.

    PubMed 21572306

  • Blackburn EH, Gall JG. A tandemly repeated sequence at the termini of the extrachromosomal ribosomal RNA genes in Tetrahymena. J Mol Biol. 1978 Mar 25;120(1):33-53. doi: 10.1016/0022-2836(78)90294-2. No abstract available.

    PubMed 642006

  • Moyzis RK, Buckingham JM, Cram LS, Dani M, Deaven LL, Jones MD, Meyne J, Ratliff RL, Wu JR. A highly conserved repetitive DNA sequence, (TTAGGG)n, present at the telomeres of human chromosomes. Proc Natl Acad Sci U S A. 1988 Sep;85(18):6622-6. doi: 10.1073/pnas.85.18.6622.

    PubMed 3413114

  • Campisi J, d'Adda di Fagagna F. Cellular senescence: when bad things happen to good cells. Nat Rev Mol Cell Biol. 2007 Sep;8(9):729-40. doi: 10.1038/nrm2233.

    PubMed 17667954

Questions about this trial

What is this clinical trial studying?

A study testing Dance Program in people with Human Immunodeficiency Virus, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Eli Puterman, PhD (604 822 2854, eli.puterman@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of women who accept the invitation to participate in the research study (time frame: Throughout the recruitment phase, up to 1.5 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05295797, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.

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