Exercise Therapy With Telerehabilitation in Patients Living With HIV

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).

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Other: Telerehabilitation Group; Other: Control group

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aysenur Tuncer, PhD; Phone Number: +90 342 211 80 80; Email: aysenur.tuncer@hku.edu.tr
• Study Contact Backup: Name: Erkin O Sari, MSc; Email: eoguz.sari@hku.edu.tr

Study Locations

• Turkey
  • Gaziantep, Turkey
    • Hasan Kalyoncu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telerehabilitation Group; 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.	Other: Telerehabilitation Group; 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.
Active Comparator: Control Group; 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.	Other: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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.	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.	Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: Hasan Kalyoncu University
• Investigators: Study Director: Aysenur Tuncer, PhD, Hasan Kalyoncu University

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): May 5, 2023

Study Registration Dates

• First Submitted: April 16, 2022
• First Submitted That Met QC Criteria: April 16, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 9, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: HIV; Telerehabilitation; Biopsychosocial Approach
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections
• Other Study ID Numbers: 2022/024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No