Tele-Rehabilitation in Adults With Cystic Fibrosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing Saud University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Tele-Rehabilitation Exercise Program
BehavioralAn 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.
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: Tele-Rehabilitation GroupExperimental treatment 1 intervention
Group B: Usual Care GroupNo intervention 0 interventions
Trial outcomes
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."
Time frame
Baseline to Week 8 (end of intervention)Secondary outcomes
1
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.
Time frame
Baseline to Week 8 (end of intervention)2
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.
Time frame
Baseline to Week 8 (end of intervention)3
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.
Time frame
Baseline to Week 8 (end of intervention)4
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.
Time frame
Baseline to Week 8 (end of intervention)Other outcomes
1
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.
Time frame
Week 8 (post-intervention)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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