Upper Limb Exercise Capacity: Lung Transplant vs. Healthy Controls

NCT07065981 | Completed

• 1 other identifier: TABED 2-25-1288
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Lung transplantation is a surgical intervention for end-stage lung diseases (e.g., COPD, cystic fibrosis, idiopathic pulmonary fibrosis). While post-transplant pulmonary function improves, peak exercise capacity remains 40-60% lower than age-matched healthy individuals due to factors like muscle weakness, reduced aerobic capacity, and immunosuppressive therapy. Although lower extremity rehabilitation is common, upper extremity (UE) function is often overlooked despite its impact on quality of life (QoL) and activities of daily living (ADLs). The 6-Minute Pegboard and Ring Test (6PBRT) evaluates UE functional capacity but has not been studied in long-term lung transplant recipients (LTRs). Objectives: Primary: Compare UE exercise capacity between LTRs and healthy controls using 6PBRT. Secondary: Investigate correlations between 6PBRT performance and pulmonary function, fatigue perception, ADLs, and QoL in LTRs. Hypotheses: H0: No significant difference in UE exercise capacity between LTRs and healthy individuals. H1: Significant difference exists. Methods: Design: Cross-sectional study. Sample size calculated based on prior 6PBRT data (effect size: 1.10, power: 80%, α: 0.05). Assessments: Demographics: Age, sex, BMI, Charlson Comorbidity Index (CCI). 6PBRT: Measures UE endurance (total rings moved in 6 minutes). Vital signs (SpO₂, heart rate, Borg scale for fatigue) recorded. LTR-specific: Pulmonary function: FEV₁, FVC, FEV₁/FVC. Fatigue: Fatigue Severity Scale (FSS; scores ≥4 indicate severe fatigue). QoL: St. George's Respiratory Questionnaire (SGRQ; 0=best, 100=worst). ADLs: London Chest ADL Questionnaire (0-5 scale). Expected Outcomes: LTRs will show significantly lower 6PBRT scores vs. controls. 6PBRT performance will correlate with pulmonary function, fatigue, and QoL in LTRs.

Conditions

Transplant Recipient

Keywords

Lung Transplant; Upper Extremity; Exercise Capacity

Outcome Measures

Primary Outcomes (1)

• Upper extremity functional exercise capacity

  Upper Extremity Functional Capacity assessed by 6-minute pegboard and ring test (6PBRT). The 6-Minute Pegboard and Ring Test (6PBRT) assesses upper limb endurance and functional capacity. The participant moves rings between pegs on a board using alternating hands for six minutes. The total number of rings moved is recorded as the outcome

  Baseline only (single assessment, no follow-up)

Secondary Outcomes (1)

• Respiratory Function

  Baseline only (no follow-up)

Study Arms (2)

Healthy Individuals

Lung Transplant Recipients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lung transplant patients who are being followed up at Bilkent City Hospital Chest Surgery Clinic

You may qualify if:

• Patients aged 18-70 years
• At least 3 months post-lung transplantation with no major complications
• Clinically stable with any comorbidities under control
• Willing to participate in the study
• No neurological or orthopedic conditions that may interfere with functional testing
• Sufficient cognitive level to understand and perform required tests and questionnaires
• Aged 18-70 years
• Sufficient cognitive ability to understand and complete the tests
• Willing to participate in the study

You may not qualify if:

• Single-lung transplant recipients
• Patients with orthopedic limitations
• Patients unable to cooperate or comply with study procedures
• Patients with mental disorders
• Presence of cardiovascular diseases, cerebrovascular disease, dementia, chronic pulmonary diseases, moderate-to-severe liver diseases, hemiplegia, moderate or severe kidney disease, or solid tumors
• Orthopedic conditions that would prevent exercise testing Inability to cooperate or comply with study procedures

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

• Fuller LM, El-Ansary D, Button BM, Corbett M, Snell G, Marasco S, Holland AE. Effect of Upper Limb Rehabilitation Compared to No Upper Limb Rehabilitation in Lung Transplant Recipients: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Jul;99(7):1257-1264.e2. doi: 10.1016/j.apmr.2017.09.115. Epub 2017 Oct 16.

  PMID: 29042172 RESULT

• Cakmak A, Kocaaga E, Sonbahar-Ulu H, Inal-Ince D, Vardar-Yagli N, Calik-Kutukcu E, Saglam M, Coplu L. Upper Extremity Exercise Capacity and Activities of Daily Living in Individuals With Bronchiectasis Versus Healthy Controls. Phys Ther. 2023 Apr 4;103(4):pzad012. doi: 10.1093/ptj/pzad012.

  PMID: 37086209 RESULT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 15, 2025
• Study Start: June 25, 2025
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)