NCT07034989

Brief Summary

This study aimed to evaluate the effectiveness of asynchronously implemented telerehabilitation-supported respiratory physiotherapy and function-oriented trunk stabilization exercises, which have not been previously applied in individuals with RA-IAH.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2025

Completed
Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

June 11, 2025

Last Update Submit

September 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Oxygen Saturation Measurement

    Evaluations started immediately after receiving ethics committee approval and will be completed within 3 months, which is the study period.

Secondary Outcomes (9)

  • Evaluation of respiratory muscle strength

    Evaluations started immediately after receiving ethics committee approval and will be completed within 3 months, which is the study period.

  • Modified Borg Scale

    Evaluations started immediately after receiving ethics committee approval and will be completed within 3 months, which is the study period.

  • Modified Medical Research Council Dyspnea Scale

    Evaluations started immediately after receiving ethics committee approval and will be completed within 3 months, which is the study period.

  • Visual Analog Scale

    Evaluations started immediately after receiving ethics committee approval and will be completed within 3 months, which is the study period.

  • Leicester Cough Survey

    Evaluations started immediately after receiving ethics committee approval and will be completed within 3 months, which is the study period.

  • +4 more secondary outcomes

Study Arms (2)

Asynchronous exercise group

ACTIVE COMPARATOR
Other: Exercise

Control Group

NO INTERVENTION

Interventions

Teach respiratory exercises and function-focused trunk stabilization exercises to individuals with RA-IAH via online platforms. Subsequently, instructional exercise videos will be delivered to the patients online. The respiratory exercise training will include thoracic expansion and diaphragmatic breathing exercises. The program will consist of a warm-up phase including 10 minutes of trunk stabilization exercises, a 40-minute functional exercise session targeting the upper and lower extremities with trunk stabilization, followed by a cooldown phase including 10 minutes of flexibility exercises involving trunk stabilization. The exercise videos related to these phases will be sent to the participants online. Participants will start the exercises with 6 repetitions and will be encouraged to increase to 8 repetitions as the program progresses. The assigned physiotherapist will contact patients once a week by phone to monitor exercise adherence.

Asynchronous exercise group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with RA according to the 2010 EULAR/American College of Rheumatology diagnostic criteria
  • Individuals with RA-associated Interstitial Lung Disease
  • Individuals aged ≥18
  • Agreeing to attend regular training throughout the study
  • Having access to the internet and a computer

You may not qualify if:

  • pack-year smoking history
  • Surgery or arthroscopic surgery within the last year
  • Having any neurological or psychological disease that may prevent participation
  • Patient's inability to comply with evaluation and education
  • Having a psychiatric disease that will affect cooperation
  • Individuals with serious functional limitations and cardiopulmonary and/or neurological disease unrelated to RA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

June 11, 2025

First Posted

June 24, 2025

Study Start

March 5, 2025

Primary Completion

September 10, 2025

Study Completion

September 20, 2025

Last Updated

September 24, 2025

Record last verified: 2025-09

Locations