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Not yet recruiting NCT07500493

Tele-Rehabilitation in Adults With Cystic Fibrosis

No phase Interventional Cystic Fibrosis Sarcopenia Frailty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tele-Rehabilitation Exercise Program.
Who it may be relevant to
Registry conditions: Cystic Fibrosis, Sarcopenia, Frailty. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Fat-Free Mass Index (FFMI) [Time frame: Baseline to Week 8 (end of intervention)]
Secondary outcome measures (4)
  • 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)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07500493 · CF-TR-2026-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗