Tele-Rehabilitation in Adults With Cystic Fibrosis (CF-TR)

The Impact of an 8-Week Tele-Rehabilitation Program on Frailty, Sarcopenia, and Quality of Life in Adults With Cystic Fibrosis

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

Study Overview

• Status: Not yet recruiting
• Conditions: Frailty; Sarcopenia; Cystic Fibrosis
• Intervention / Treatment: Behavioral: Tele-Rehabilitation Exercise Program

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amal A Alkhalfan; Phone Number: +966532870852; Email: 445205964@student.ksu.edu.sa
• Study Contact Backup: Name: Ali M Albarrati; Phone Number: +966553215665

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tele-Rehabilitation Group; 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; 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.
No Intervention: Usual Care Group; Participants will continue receiving standard clinical care without participation in the tele-rehabilitation program during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
FRAIL Scale Score	Frailty will be assessed using the FRAIL scale, a validated screening tool evaluating fatigue, resistance, ambulation, illnesses, and weight loss. The outcome measure is the total FRAIL scale score (range: 0 to 5), with higher scores indicating greater frailty.	Baseline to Week 8 (end of intervention)
Fried Frailty Phenotype (FFP)	Frailty will also be assessed using the Fried Frailty Phenotype (FFP), which includes five criteria: unintentional weight loss, exhaustion, low physical activity, slow gait speed, and weak handgrip strength. The outcome measure is the number of criteria met (range: 0 to 5), with higher scores indicating greater frailty status.	Baseline to Week 8 (end of intervention)
Quality of Life (CFQoL)	Quality of life will be assessed using the Cystic Fibrosis Quality of Life (CFQoL) questionnaire, which evaluates multiple domains including physical, emotional, and social functioning. The outcome measure is the total CFQoL score, with higher scores indicating better quality of life.	Baseline to Week 8 (end of intervention)
Physical Performance	Physical performance will be assessed using the Timed Up and Go (TUG) test. The outcome measure is the time taken to complete the test (in seconds), with lower values indicating better functional mobility and performance.	Baseline to Week 8 (end of intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction with Tele-Rehabilitation	Patient satisfaction will be assessed using the Telehealth Usability Questionnaire (TUQ), a validated tool evaluating usefulness, ease of use, interface quality, interaction quality, reliability, and satisfaction. The outcome measure is the total TUQ score, with each item rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Higher scores indicate greater satisfaction with the tele-rehabilitation program.	Week 8 (post-intervention)

Collaborators and Investigators

• Sponsor: King Saud University

Study record dates

Study Major Dates

• Study Start (Estimated): April 17, 2026
• Primary Completion (Estimated): June 17, 2026
• Study Completion (Estimated): July 17, 2026

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Pathological Conditions, Anatomical; Genetic Diseases, Inborn; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases; Pancreatic Diseases; Muscular Atrophy; Atrophy; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Frailty; Sarcopenia; Cystic Fibrosis
• Other Study ID Numbers: CF-TR-2026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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