HIV InfectionsNCT05342337
Exercise Therapy With Telerehabilitation in Patients Living With HIV
A study testing Telerehabilitation Group in people with HIV Infections, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
To investigate the effectiveness of the Biopsychosocial Exercise Therapy Approach (BETY) approach with the Telerehabilitation in patients living with HIV (PLWH). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Telerehabilitation Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2022to 5 May 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients living with HIV (PLWH),
- Ages between 18 and 65 years old,
- Participants attend and follow instructions through telerehabilitation.
Who cannot join
- Participants who use recreational drugs
- Participants who do not adapt to the exercises through telerehabilitation,
- Participants who did not agree to be volunteers are not included in our study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Biopsychosocial Exercise Therapy Approach With Telerehabilitation in Patients Living With HIV
To investigate the effectiveness of the Biopsychosocial Exercise Therapy Approach (BETY) approach with the Telerehabilitation in patients living with HIV (PLWH).
Read the detailed description
55 individuals living with HIV (PLWH) were included in the study. Among those individuals, 25 individuals who volunteer to exercise with telerehabilitation will be grouped in the telerehabilitation group. The rest of the individuals who do not participate in the exercise group will be in the control group.
Group 1: Telerehabilitation group: Individuals in the telerehabilitation group attend sessions that last for one and a half hours, 3 days a week for 12 weeks, in the company of an investigator over the videoconference through zoom. The investigator, who provides supervision during the sessions, also participates in the exercises simultaneously.
Group 2: Control group: Individuals in the control group continue their routine drugs.
Both the telerehabilitation exercise group and the control group continue their drug treatments during the 12 weeks of the period.
- Conditions
- HIV Infections
- Being tested
- Telerehabilitation Group, Control group
- Keywords
- HIV, Telerehabilitation, Biopsychosocial Approach
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation GroupOther
The Telerehabilitation program includes a Biopsychosocial Exercise Therapy (BETY) approach.
BETY approach includes patient education on pain, functional body stabilization exercises (mind-body information management), dance therapy authentic movement (emotion-state information management), and sexual information management.
Telerehabilitation group participate in the sessions that last for one and a half hours, 3 days a week for 12 weeks, video conference over the Zoom program. The investigator, who provides supervision during the sessions, also participates in the exercises simultaneously.
Control groupOther
The control group participants include those who do not want to receive exercise treatment with telerehabilitation and take their routine medications during the 12 weeks period.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Group | Experimental | The Telerehabilitation program includes a Biopsychosocial Exercise Therapy (BETY) approach.
BETY approach includes patient education on pain, functional body stabilization exercises (mind-body information management), dance therapy authentic movement (emotion-state information management), and sexual information management. Receives: Other: Telerehabilitation Group |
| Control Group | Active comparator | The control group participants include those who do not want to receive exercise treatment with telerehabilitation and take their routine medications during the 12 weeks period. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Biopsychosocial Exercise Therapy Questionnaire (BETY-BQ) at 12 weeks
The Biopsychosocial Exercise Therapy Questionnaire (BETY-BQ), consists of 30 questions. Each of the items on the scale is scored between 0-and 4 in accordance with the Likert system. A higher score indicates a poor biopsychosocial status (4: Yes always, 3: Yes often, 2: Yes sometimes, 1: Yes rarely, 0: No, never).
Measured: Baseline, 12 weeks
Change from Baseline in Short Form-36 (SF-36) at 12 weeks
The Short Form-36 (SF-36) scale, is the most commonly used quality of life scale that evaluate physical and mental health. İt consists of 8 subscales. These subscales, physical function, physical orientation role restriction, pain, general health, vitalization, social function, emotional role restrictiveness, and mental health. Points range from 0-to 100 and the best health status of 100 points shows the worst health status of 0 points.
Measured: Baseline, 12 weeks
Change from Baseline in Hospital Anxiety and Depression Scale (HADS) at 12 weeks
The HADS is a self-rating scale. It contains two subscales measuring symptoms of depression (HADS-D) and anxiety (HADS-A) during the previous week. It includes seven statements on each disorder, and each response consists of a four-point rating scale (0 to 3); a higher score depicts a worse condition. For each subscale, the total score is at most 21. A score of ≥11 is considered a clinically significant disorder, whereas a score between 8 and 10 suggests a mild disorder.
Measured: Baseline, 12 weeks
Change from Baseline in FRAIL scale at 12 weeks
The FRAIL scale is a clinical frailty screening tool. It consists of five components: Fatigue, resistance, ambulation, illness, and loss of weight (score range 0-5), and evaluates the status and severity of frailty. The presence of ≥3 components in a participants is considered frailty, while the presence of more components indicates more serious vulnerability.
Measured: Baseline, 12 weeks
Change from Baseline in Clinical Frailty Scale (CFS) scale at 12 weeks
The Clinical Frailty Scale is an inclusive 9-point scale to summarize the overall level of fitness or frailty of participants. The scale can be easily applied to the participants. İt is based on a subjective clinical assessment categorized by the investigators. A clinical fragile scale score greater than four is to be fragility and clinical indicator. Higher scores mean greater risk.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start2 May 2022
- Primary completion1 Sep 2022
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysenur Tuncer, Hasan Kalyoncu University
- Investigators
- Aysenur Tuncer, PhD, Study director, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342337
- Sponsor's protocol ID
- 2022/024
- Status last verified
- Apr 2022
- First submitted
- 16 Apr 2022
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Biopsychosocial Exercise Therapy Approach With Telerehabilitation in Patients Living With HIV
- ClinicalTrials.gov ID
- NCT05342337
- Acronym / sponsor ID
- 2022/024
- Conditions
- HIV Infections
- Keywords
- HIV, Telerehabilitation, Biopsychosocial Approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effectiveness of the Biopsychosocial Exercise Therapy Approach (BETY) approach with the Telerehabilitation in patients living with HIV (PLWH).
Detailed description
55 individuals living with HIV (PLWH) were included in the study. Among those individuals, 25 individuals who volunteer to exercise with telerehabilitation will be grouped in the telerehabilitation group. The rest of the individuals who do not participate in the exercise group will be in the control group.
Group 1: Telerehabilitation group: Individuals in the telerehabilitation group attend sessions that last for one and a half hours, 3 days a week for 12 weeks, in the company of an investigator over the videoconference through zoom. The investigator, who provides supervision during the sessions, also participates in the exercises simultaneously.
Group 2: Control group: Individuals in the control group continue their routine drugs.
Both the telerehabilitation exercise group and the control group continue their drug treatments during the 12 weeks of the period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation Group | Experimental | Other: Telerehabilitation GroupThe Telerehabilitation program includes a Biopsychosocial Exercise Therapy (BETY) approach. BETY approach includes patient education on pain, functional body stabilization exercises (mind-body information management), dance therapy authentic movement (emotion-state information management), and sexual information management. |
| Control Group | Active comparator | Other: Control groupThe control group participants include those who do not want to receive exercise treatment with telerehabilitation and take their routine medications during the 12 weeks period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients living with HIV (PLWH),
- Ages between 18 and 65 years old,
- Participants attend and follow instructions through telerehabilitation.
Key exclusion criteria (3 listed)
- Participants who use recreational drugs
- Participants who do not adapt to the exercises through telerehabilitation,
- Participants who did not agree to be volunteers are not included in our study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telerehabilitation GroupThe Telerehabilitation program includes a Biopsychosocial Exercise Therapy (BETY) approach. BETY approach includes patient education on pain, functional body stabilization exercises (mind-body information management), dance therapy authentic movement (emotion-state information management), and sexual information management. Telerehabilitation group participate in the sessions that last for one and a half hours, 3 days a week for 12 weeks, video conference over the Zoom program. The investigator, who provides supervision during the sessions, also participates in the exercises simultaneously. | Other | Telerehabilitation Group |
| Control groupThe control group participants include those who do not want to receive exercise treatment with telerehabilitation and take their routine medications during the 12 weeks period. | Other | Control Group |
Primary outcome
Change from Baseline in Biopsychosocial Exercise Therapy Questionnaire (BETY-BQ) at 12 weeks
Time frame: Baseline, 12 weeks
The Biopsychosocial Exercise Therapy Questionnaire (BETY-BQ), consists of 30 questions. Each of the items on the scale is scored between 0-and 4 in accordance with the Likert system. A higher score indicates a poor biopsychosocial status (4: Yes always, 3: Yes often, 2: Yes sometimes, 1: Yes rarely, 0: No, never).
Change from Baseline in Short Form-36 (SF-36) at 12 weeks
Time frame: Baseline, 12 weeks
The Short Form-36 (SF-36) scale, is the most commonly used quality of life scale that evaluate physical and mental health. İt consists of 8 subscales. These subscales, physical function, physical orientation role restriction, pain, general health, vitalization, social function, emotional role restrictiveness, and mental health. Points range from 0-to 100 and the best health status of 100 points shows the worst health status of 0 points.
Change from Baseline in Hospital Anxiety and Depression Scale (HADS) at 12 weeks
Time frame: Baseline, 12 weeks
The HADS is a self-rating scale. It contains two subscales measuring symptoms of depression (HADS-D) and anxiety (HADS-A) during the previous week. It includes seven statements on each disorder, and each response consists of a four-point rating scale (0 to 3); a higher score depicts a worse condition. For each subscale, the total score is at most 21. A score of ≥11 is considered a clinically significant disorder, whereas a score between 8 and 10 suggests a mild disorder.
Change from Baseline in FRAIL scale at 12 weeks
Time frame: Baseline, 12 weeks
The FRAIL scale is a clinical frailty screening tool. It consists of five components: Fatigue, resistance, ambulation, illness, and loss of weight (score range 0-5), and evaluates the status and severity of frailty. The presence of ≥3 components in a participants is considered frailty, while the presence of more components indicates more serious vulnerability.
Change from Baseline in Clinical Frailty Scale (CFS) scale at 12 weeks
Time frame: Baseline, 12 weeks
The Clinical Frailty Scale is an inclusive 9-point scale to summarize the overall level of fitness or frailty of participants. The scale can be easily applied to the participants. İt is based on a subjective clinical assessment categorized by the investigators. A clinical fragile scale score greater than four is to be fragility and clinical indicator. Higher scores mean greater risk.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysenur Tuncer, PhD study director
Hasan Kalyoncu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation Group in people with HIV Infections, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 11 Jul 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Biopsychosocial Exercise Therapy Questionnaire (BETY-BQ) at 12 weeks (time frame: Baseline, 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2023.