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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual Care Group | No Intervention | Participants will continue receiving standard clinical care without participation in the tele-rehabilitation program during the study period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele-Rehabilitation Exercise Program | Behavioral | 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. |
| 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) |
| 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) |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amal A Alkhalfan | Contact | +966532870852 | 445205964@student.ksu.edu.sa | |
| Ali M Albarrati | Contact | +966553215665 |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D055948 | Sarcopenia |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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|
| 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) |
| Week 8 (post-intervention) |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010335 | Pathologic Processes |