Exercise Therapy With Telerehabilitation in Patients Living With HIV

NCT05342337 | Completed

• 1 other identifier: 2022/024
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effectiveness of the Biopsychosocial Exercise Therapy Approach (BETY) approach with the Telerehabilitation in patients living with HIV (PLWH).

Conditions

HIV Infections

Keywords

HIV; Telerehabilitation; Biopsychosocial Approach

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

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.

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.

Other: Control group

Interventions

Telerehabilitation Group OTHER

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.

Telerehabilitation Group

Control group OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients living with HIV (PLWH),
• Ages between 18 and 65 years old,
• Participants attend and follow instructions through telerehabilitation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Aysenur Tuncer, PhD

  Hasan Kalyoncu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 16, 2022
• First Posted: April 22, 2022
• Study Start: May 2, 2022
• Primary Completion: September 1, 2022
• Study Completion: May 5, 2023
• Last Updated: July 11, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)