跳至主要内容
临床试验/CTRI/2024/02/062383
CTRI/2024/02/062383尚未招募Phase 3 4

Effect of Pulmonary rehabilitation on the exercise tolerance in sputum positive pulmonary TB patients

ICMR INTRAMURAL FUNDING1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年2月14日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
240
试验地点
1
主要终点
1.Primary Outcome:

研究概览

简要总结

Usual care (control arm)

The participants in the control arm will receive standard of care at NTEP centres. Sputa examination, CXR, spirometry, transition dyspnoea index, 6MWT, and QOL assessment will be done at baseline (at randomisation), at 16 weeks post randomisation, at 6,12 and 18 months post ATT completion.

Pulmonary Rehabilitation (PR) (trial intervention arm)

In addition to usual care described above, participants in the intervention arm will receive PR. PR will consist of a 16-week programme offered to participants, with sessions occurring twice weekly for at least 1 hour- 6 weeks initially in an outpatient basis, 6 weeks later at home followed by two weeks each in outpatient basis and at home or will be done as an intense 8 weeks daily monitored program on admission and 8 weeks program being done at home. At home PR adherence will be ensured over telephonic communication.

16-week outpatient program

2 days in a week for 8 weeks in Outpatient department and for 8 weeks at home.

 16 weeks inpatient program

8 weeks daily monitored program and 8 weeks at home.

 Â·         Health education awareness sessions on lung health, verbal advice to quit smoking and reduce exposure to biomass smoke, stress management.

  • Lower and upper limb strength training and extensor exercises
  • Respiratory exercises (stretching and relaxing)
  • Lower limb endurance training (walking exercises)
  • Healthy food intake- Nutritional counselling on balanced diet
  • Secretion clearance techniques.
  • Breathing techniques including Yoga techniques.

Exercise intensity during each session is incremental and graded according to symptom tolerance.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.aged ≥18 years, 2.willing and able to provide written informed consent 3.a documented history of smear positive pulmonary TB with treatment initiated at selected NTEP centres with smear negative status during the Intensive Phase 4.A report of Medical Research Council (MRC) dyspnoea grade ≥2.

排除标准

  • Previous episode of TB treatment
  • any skeletal deformity that intervenes with physical exercises.
  • unwilling to participate for any reason.

结局指标

主要结局

1.Primary Outcome:

时间窗: at baseline and at the end of TB treatment

-A change in walking distance measured by the 6 MWT pre-intervention to post-intervention.

时间窗: at baseline and at the end of TB treatment

2. Secondary Outcome:

时间窗: at baseline and at the end of TB treatment

-Measurement of association between lung function impairment and radiological changes

时间窗: at baseline and at the end of TB treatment

-Proportion of participants with optimal respiratory health status

时间窗: at baseline and at the end of TB treatment

次要结局

  • 1.Primary Outcome:(-A change in walking distance measured by the 6 MWT pre-intervention to post-intervention.)
  • Secondary Outcome:(-Measurement of association between lung function impairment & radiological changes)

研究者

发起方
ICMR INTRAMURAL FUNDING
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Poorana Ganga Devi

ICMR NIRT

研究点 (1)

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