Cystic FibrosisCF-TRNCT07500493
Tele-Rehabilitation in Adults With Cystic Fibrosis
A study testing Tele-Rehabilitation Exercise Program in people with Cystic Fibrosis and Sarcopenia, run by King Saud University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Sarcopenia, Frailty
- What is being tested?
- Tele-Rehabilitation Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 17 Apr 2026to 17 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ali M Albarrati contact
About this study
Official title: 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
- Conditions
- Cystic Fibrosis, Sarcopenia, Frailty
- Being tested
- Tele-Rehabilitation Exercise Program
- Medical subject headings
- Cystic Fibrosis, Sarcopenia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-Rehabilitation Exercise ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: Baseline to Week 8 (end of intervention)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 8 (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start17 Apr 2026 (estimated)
- Primary completion17 Jun 2026 (estimated)
- Study completion17 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Albarrati, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500493
- Sponsor's protocol ID
- CF-TR-2026-01
- Acronym
- CF-TR
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of an 8-Week Tele-Rehabilitation Program on Frailty, Sarcopenia, and Quality of Life in Adults With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT07500493
- Acronym / sponsor ID
- CF-TR / CF-TR-2026-01
- Conditions
- Cystic Fibrosis, Sarcopenia, Frailty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 17 Apr 2026 (estimated)
- Primary completion
- 17 Jun 2026 (estimated)
- Study completion
- 17 Jul 2026 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-Rehabilitation Group | Experimental | Behavioral: Tele-Rehabilitation Exercise ProgramParticipants 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. |
| Usual Care Group | No intervention | –Participants will continue receiving standard clinical care without participation in the tele-rehabilitation program during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-Rehabilitation Exercise ProgramAn 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. | Behavioural | Tele-Rehabilitation Group |
Primary outcome
Fat-Free Mass Index (FFMI)
Time frame: 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."
4 secondary outcomes
FRAIL Scale Score
Time frame: Baseline to Week 8 (end of intervention)
Fried Frailty Phenotype (FFP)
Time frame: Baseline to Week 8 (end of intervention)
Quality of Life (CFQoL)
Time frame: Baseline to Week 8 (end of intervention)
Physical Performance
Time frame: Baseline to Week 8 (end of intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali M Albarrati contact
Questions about this trial
What is this clinical trial studying?
A study testing Tele-Rehabilitation Exercise Program in people with Cystic Fibrosis and Sarcopenia, run by King Saud University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amal A Alkhalfan (+966532870852, 445205964@student.ksu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat-Free Mass Index (FFMI) (time frame: Baseline to Week 8 (end of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.