Exercise Therapy for Isotretinoin Users

NCT07196787 | Recruiting

• 1 other identifier: Asli1
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Isotretinoin (13-cis retinoic acid) is a retinoic acid that is a derivative of vitamin A. Isotretinoin has been used effectively alone in acne treatment for 35 years. However, it has many side effects. Among the musculoskeletal side effects of this treatment, acute sacroileitis is a common condition. In this clinical picture, recovery may last for a few months after discontinuation of isotretinoin treatment. However, it may become permanent in some cases. According to our current knowledge, there is no study in the literature that prescribes exercise therapy for this patient group. This study, planned to investigate the effects of stretching and sacroiliac mobilization exercises on musculoskeletal pain and quality of life, which are among the side effects of isotretinoin treatment.

Conditions

Isotretinoin; Isotretinoin Adverse Reaction

Keywords

exercise; pain; prophylaxis; side effects

Outcome Measures

Primary Outcomes (2)

• Pressure Algometer Testing

  Device: Jtech Medical 801/478 USA™ digital pressure algometer. Data collected and processed from the human algometer will generate a specific nociceptive response to neurostimulation in the somatosensory cortex. The algometer head was applied at a 90° angle to trigger points at selected locations, with pressure increased at a speed of approximately 100 g/s. One measurement was taken at the first sensation of pain, after which the process stopped.

  Baseline / first month / third month / sixth month

• Short Form 36

  The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Pricing depends on the number of scores that the researcher needs to calculate.

  Baseline / first month / third month / sixth month

Secondary Outcomes (1)

• VAS (visual analogue scale)

  Baseline / first month / third month / sixth month

Study Arms (2)

Sacroiliac (SI) joint exercise group

EXPERIMENTAL

This 18-week, 5-day-a-week program is a comprehensive plan designed to build stability, strength, and mobility progressively while being mindful of the sensitivity of the SI joint. This program is divided into three 6-week phases. Each week consists of 5 sessions, mixing different focuses to ensure balanced development. Day 1: Foundational Strength \& Stability Day 2: Low-Impact Cardio \& Active Recovery Day 3: Core Focus \& Hip Stability Day 4: Low-Impact Cardio \& Mobility Day 5: Full Body Integration \& Strength

Other: Exercise

Control group

NO INTERVENTION

Control group: No intervention

Interventions

Exercise OTHER

The 18-Week Program Structure This program is divided into three 6-week phases. Each week consists of 5 sessions, mixing different focuses to ensure balanced development. Day 1: Foundational Strength \& Stability Day 2: Low-Impact Cardio \& Active Recovery Day 3: Core Focus \& Hip Stability Day 4: Low-Impact Cardio \& Mobility Day 5: Full Body Integration \& Strength

Sacroiliac (SI) joint exercise group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The participant is between the ages of 18-35,
• Not having a regular exercise habit,
• Starting Isotretinoin treatment for the first time.

You may not qualify if:

• Presence of any diagnosed rheumatologic disease,
• The presence of any diagnosed neurological disease,
• Having any diagnosed psychiatric illness,
• Having a physical disability that prevents them from exercising for any reason.

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

Usak University

Uşak, 64200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Motor Activity; Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ali Y Karahan, MD

  Uşak University

  STUDY DIRECTOR

Central Study Contacts

Asli K Önal, MD

CONTACT

+905056842590; asli.keles89@hotmail.com

Ali Y karahan, MD

CONTACT

+905386921934; ali.karahan@usak.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The physiotherapist performing the outcome measurements will be unaware of the study protocol and the study groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Controlled study

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 29, 2025
• Study Start: September 30, 2025
• Primary Completion: February 6, 2026
• Study Completion: March 26, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From September 2026, the datasets created and/or examined during the present study will be accessible to the public from the person responsible for the study.
• Access Criteria: Plan to Share IPD: "Yes" Plan Description: "No individual participant data will be shared. Results will be published by the investigators in academic journals.

Locations

TU (1)