Pulmonary Rehabilitation Program in Patients With Post-Tuberculosis Lung Disease
Immediate and Three-Month Effects of a Pulmonary Rehabilitation Program in Patients With Post-Tuberculosis Lung Disease: A Prospective Longitudinal Study
調査の概要
状態
詳細な説明
Persistent impairment after successfully treated pulmonary tuberculosis is increasingly recognized as an important source of chronic respiratory morbidity. Patients may experience dyspnea, exercise intolerance, fatigue, impaired mobility, and reduced health-related quality of life. Preliminary retrospective data from 37 patients suggested that structured pulmonary rehabilitation may improve the 6-minute walk distance, Timed Up and Go performance, dyspnea, perceived exertion, quality of life, and selected inflammatory indices. However, retrospective allocation and the absence of a longer follow-up limit causal interpretation.
The present study is designed as a prospective, assessor-blinded, parallel-group randomized controlled trial. It will assess both the immediate response to an individualized rehabilitation program and the maintenance of benefit three months after the supervised program has ended. The intervention combines aerobic training, resistance training, breathing exercises, education, and individualized symptom-management strategies. The control group will receive usual post-tuberculosis medical care and general physical-activity advice without a structured supervised pulmonary rehabilitation program during the study period.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：MAGDALENA-RODICA TRAISTARU, Professor, PhD
- 電話番号：+40723766778
- メール：rodica.traistaru@umfcv.ro
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
• Age 18 years or older.
- Documented history of pulmonary tuberculosis with anti-tuberculosis treatment completed according to national standards.
- No clinical evidence of active or relapsed tuberculosis at enrollment; microbiological reassessment will be performed when clinically indicated.
- Persistent respiratory symptoms, exercise limitation, or functional impairment considered attributable to post-tuberculosis lung disease.
- Clinical stability for at least 4 weeks before randomization, with no acute respiratory infection or acute exacerbation requiring treatment change.
- Ability to walk independently, with or without a usual assistive device, and to perform the study assessments.
- Ability to understand the study procedures and provide written informed consent.
Exclusion Criteria:
• Suspected or confirmed active, recurrent, or drug-resistant tuberculosis requiring treatment or isolation.
- Acute respiratory infection or acute cardiopulmonary decompensation within 4 weeks before enrollment.
- Unstable angina, recent myocardial infarction, uncontrolled arrhythmia, decompensated heart failure, severe uncontrolled hypertension, or another contraindication to exercise testing/training.
- Severe neurological, musculoskeletal, or cognitive impairment that prevents safe participation or valid outcome assessment.
- Current participation in another structured pulmonary rehabilitation or supervised exercise program.
- Planned major surgery or another condition likely to prevent completion of the 20-week follow-up.
- Any condition judged by the investigator to make participation unsafe or to substantially interfere with interpretation of the outcomes.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Individualized Pulmonary Rehabilitation Plus Standard Care
Participants assigned to the experimental arm will receive an 8-week individualized pulmonary rehabilitation program in addition to standard post-tuberculosis medical care.
The program will include three supervised sessions per week, each lasting approximately 60 minutes, consisting of aerobic training, resistance exercises, breathing exercises, education, symptom-management strategies, and an individualized home exercise program.
Outcome assessments will be performed at baseline, immediately after the 8-week intervention, and three months after completion of the rehabilitation program.
|
The intervention consists of an 8-week individualized outpatient pulmonary rehabilitation program, delivered through three supervised sessions per week, with each session lasting approximately 60 minutes. Each session will include: 5-10 minutes of warm-up and mobility exercises; 20-30 minutes of individualized aerobic training, such as walking, treadmill exercise, or cycle ergometry; resistance exercises targeting the major upper- and lower-limb muscle groups; breathing exercises, including diaphragmatic breathing, pursed-lip breathing, and thoracic expansion exercises; airway-clearance techniques when clinically indicated; education regarding symptom monitoring, energy conservation, physical activity, treatment adherence, and healthy lifestyle; an individualized home exercise program on non-supervised days. Exercise intensity and progression will be individualized according to baseline functional capacity, symptoms, Borg CR10 score, heart rate, oxygen saturation, comorbidities, and
Standard Post-Tuberculosis Care
|
|
アクティブコンパレータ：Standard Post-Tuberculosis Care
Participants assigned to the control arm will receive standard post-tuberculosis medical care, including routine clinical follow-up, management of respiratory symptoms and comorbidities, and general recommendations regarding physical activity.
Participants in this arm will not receive a structured or supervised pulmonary rehabilitation program during the 20-week study period.
Outcome assessments will be performed at baseline, at Week 8, and at Week 20.
|
Standard Post-Tuberculosis Care
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline in EUROHIS-QOL-8 Total Score
時間枠：Baseline, Week 8, and Week 20.
|
Generic quality of life will be assessed using the EUROHIS-QOL-8 questionnaire.
The questionnaire contains eight items scored from 1 to 5. The total score ranges from 8 to 40, with higher scores indicating better quality of life.
A positive change indicates improvement.
|
Baseline, Week 8, and Week 20.
|
|
Change From Baseline in St George's Respiratory Questionnaire Total Score at Week 20
時間枠：Baseline to Week 20, corresponding to three months after completion of the 8-week pulmonary rehabilitation program.
|
Respiratory health-related quality of life will be assessed using the St George's Respiratory Questionnaire (SGRQ).
The total score ranges from 0 to 100, with higher scores indicating greater impairment.
The outcome will be calculated as the Week 20 score minus the baseline score.
A negative change indicates an improvement in respiratory health-related quality of life.
|
Baseline to Week 20, corresponding to three months after completion of the 8-week pulmonary rehabilitation program.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline in Six-Minute Walk Distance
時間枠：Baseline, Week 8, and Week 20
|
Functional exercise capacity will be assessed using the 6-Minute Walk Test.
The total distance walked in six minutes will be recorded in meters.
A greater walking distance indicates better functional exercise capacity.
|
Baseline, Week 8, and Week 20
|
|
Change From Baseline in Timed Up and Go Test Performance
時間枠：Baseline, Week 8, and Week 20.
|
Functional mobility will be assessed using the Timed Up and Go test.
The time required for the participant to stand up from a chair, walk 3 meters, turn, return to the chair, and sit down will be recorded in seconds.
A shorter completion time indicates better functional mobility.
|
Baseline, Week 8, and Week 20.
|
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Change From Baseline in Modified Medical Research Council Dyspnea Grade
時間枠：Baseline, Week 8, and Week 20.
|
Dyspnea during daily activities will be assessed using the modified Medical Research Council scale.
Scores range from 0 to 4, with higher scores indicating greater dyspnea-related functional limitation.
A reduction in score indicates improvement.
|
Baseline, Week 8, and Week 20.
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- UMFCV-PTLD-2026-001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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