Exercise Therapy With Telerehabilitation in Patients Living With HIV
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation Group
Control group
Sponsored by

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, Telerehabilitation, Biopsychosocial Approach
Eligibility Criteria
Inclusion Criteria:
- Patients living with HIV (PLWH),
- Ages between 18 and 65 years old,
- Participants attend and follow instructions through telerehabilitation.
Exclusion Criteria:
- 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.
Sites / Locations
- Hasan Kalyoncu University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telerehabilitation Group
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05342337
Brief Title
Exercise Therapy With Telerehabilitation in Patients Living With HIV
Official Title
Investigation of the Effectiveness of Biopsychosocial Exercise Therapy Approach With Telerehabilitation in Patients Living With HIV
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
May 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Telerehabilitation, Biopsychosocial Approach
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telerehabilitation Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Biopsychosocial Exercise Therapy Questionnaire (BETY-BQ) at 12 weeks
Description
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).
Time Frame
Baseline, 12 weeks
Title
Change from Baseline in Short Form-36 (SF-36) at 12 weeks
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change from Baseline in Hospital Anxiety and Depression Scale (HADS) at 12 weeks
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change from Baseline in FRAIL scale at 12 weeks
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change from Baseline in Clinical Frailty Scale (CFS) scale at 12 weeks
Description
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.
Time Frame
Baseline, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients living with HIV (PLWH),
Ages between 18 and 65 years old,
Participants attend and follow instructions through telerehabilitation.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysenur Tuncer, PhD
Organizational Affiliation
Hasan Kalyoncu University
Official's Role
Study Director
Facility Information:
Facility Name
Hasan Kalyoncu University
City
Gaziantep
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exercise Therapy With Telerehabilitation in Patients Living With HIV
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