Cystic Fibrosis, Sarcopenia, Frailty
Conditions
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
Interventions
BEHAVIORALTele-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.
Sponsors
King Saud University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fat-Free Mass Index (FFMI) | Baseline to Week 8 (end of intervention) | 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." |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FRAIL Scale Score | Baseline to Week 8 (end of intervention) | 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. |
| Fried Frailty Phenotype (FFP) | Baseline to Week 8 (end of intervention) | 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. |
| Quality of Life (CFQoL) | Baseline to Week 8 (end of intervention) | 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. |
| Physical Performance | Baseline to Week 8 (end of intervention) | 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. |
Contacts
CONTACTAmal A Alkhalfan
CONTACTAli M Albarrati
Outcome results
None listed