Tele-Rehabilitation in Adults With Cystic Fibrosis

NCT07500493 | Not Yet Recruiting

• 1 other identifier: CF-TR-2026-01
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a randomized controlled trial designed to evaluate the effectiveness of an 8-week tele-rehabilitation program in adults with cystic fibrosis. Cystic fibrosis is a chronic condition that affects the lungs and can lead to reduced muscle mass, physical weakness, frailty, and decreased quality of life. Participants will be randomly assigned to either a tele-rehabilitation group or a usual care group. The tele-rehabilitation program includes supervised exercise sessions conducted remotely three times per week using video communication. The program combines aerobic and resistance training based on established rehabilitation guidelines. The primary aim of the study is to assess the effect of the program

Conditions

Cystic Fibrosis; Sarcopenia; Frailty

Outcome Measures

Primary Outcomes (1)

• Fat-Free Mass Index (FFMI)

  Fat-free mass index (FFMI) will be used as the primary measure of muscle mass. FFMI will be assessed using body composition analysis and expressed as fat-free mass divided by height squared (kg/m²), with higher values indicating greater muscle mass."

  Baseline to Week 8 (end of intervention)

Secondary Outcomes (4)

• FRAIL Scale Score

  Baseline to Week 8 (end of intervention)

• Fried Frailty Phenotype (FFP)

  Baseline to Week 8 (end of intervention)

• Quality of Life (CFQoL)

  Baseline to Week 8 (end of intervention)

• Physical Performance

  Baseline to Week 8 (end of intervention)

Other Outcomes (1)

• Patient Satisfaction with Tele-Rehabilitation

  Week 8 (post-intervention)

Study Arms (2)

Tele-Rehabilitation Group

EXPERIMENTAL

Participants will receive an 8-week tele-rehabilitation program consisting of supervised aerobic and resistance exercise sessions delivered remotely three times per week. The program will be individualized and progressively adjusted based on participant tolerance and clinical status.

Behavioral: Tele-Rehabilitation Exercise Program

Usual Care Group

NO INTERVENTION

Participants will continue receiving standard clinical care without participation in the tele-rehabilitation program during the study period.

Interventions

Tele-Rehabilitation Exercise Program BEHAVIORAL

An 8-week tele-rehabilitation program consisting of supervised aerobic and resistance exercise sessions delivered remotely three times per week using video communication. The program includes individualized exercise prescription and progressive adjustment based on participant tolerance and clinical status. Sessions are conducted by trained rehabilitation personnel following established pulmonary rehabilitation guidelines.

Tele-Rehabilitation Group

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years and older
• Confirmed diagnosis of cystic fibrosis
• Clinically stable condition with no acute exacerbation at the time of enrollment
• Ability to participate in an exercise program
• Access to a device with internet connection for tele-rehabilitation sessions
• Willingness to provide informed consent

You may not qualify if:

• Acute pulmonary exacerbation within the past 4 weeks
• Severe comorbidities that limit participation in exercise (e.g., unstable cardiovascular disease)
• Musculoskeletal or neurological conditions preventing safe exercise performance
• Cognitive impairment affecting ability to follow instructions
• Participation in another structured rehabilitation or clinical trial during the study period
• Pregnancy (if applicable based on your protocol)

Sponsors & Collaborators

• King Saud University: lead

MeSH Terms

Conditions

Cystic Fibrosis; Sarcopenia; Frailty

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Central Study Contacts

Amal A Alkhalfan

CONTACT

+966532870852; 445205964@student.ksu.edu.sa

Ali M Albarrati

CONTACT

+966553215665

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: PRINCIPAL INVESTIGATOR
• PI Title: Professor/Cardiorespiratory Rehabilitation Consultant

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 30, 2026
• Study Start: April 17, 2026
• Primary Completion (Estimated): June 17, 2026
• Study Completion (Estimated): July 17, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03