跳至主要内容
临床试验/CTRI/2023/04/052038
CTRI/2023/04/052038进行中(未招募)不适用

Effect of inspiratory muscle training combined with whole-body endurance training program on balance in interstitial lung disease

Centre for physiotherapy and rehabilitation sciences Jamia Millia Islamia2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2023年4月30日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
46
试验地点
2
主要终点
Berg Balance Scale (BBS)

研究概览

简要总结

Patients with documented ILD will be recruited fromMetro Centre for Respiratory Disease, Noida , UP, and will be informed aboutthe study. Subjects will be explained the purpose and methodology and possiblerisks of the study. They will be given an informed consent form explainingtheir rights as research subjects. They will be selected based on inclusioncriteria and exclusion criteria and divided into two groups: (experimentalgroup 1, G=23) and (Control group 2, G2=23). All identifying information on theconsent form and demographic history/ screening questionnaires will be keptconfidential. Before initial training, each patient will undergo a primaryhealth evaluation, PARQ (Physical Activity Readiness Questionnaire) andinterview (including complete pharmacological and family history). The initialassessment will be done on first visit. It will include anthropometricmeasures. Balance will be assessed by Berg Balance Scale (BBS), Timed Up and Go(TUG), Single Leg Stance test (SLS) and Activities-specific Balance Confidence(ABC) Scale. Besides Maximal inspiratory pressure and Six-minute walk test willbe assessed. Control group and experimental groups will be allowed to practicetheir usual routines and medications. An 8-week pulmonary rehabilitation willbe given to both the groups, but the inspiratory muscle training (by IMTPowerbreathe medic) will be addition only in the experimental group. Thestudy will be carried out in the Pulmonary Rehab of Metro Centre forRespiratory Diseases, Noida, UP, India.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
45.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • •HRCT (High resolution Computed Tomography) diagnosed Interstitial lung disease •Only patients with forced expiratory volume in 1 s (FEV1) <80% predicted.
  • •FEV1/forced vital capacity (FVC) <70% will be eligible to participate in the study.
  • •They will be between 45-75 years of age, and clinically stable.

排除标准

  • •Cardiovascular problems.
  • •Diagnosed psychiatric or cognitive disorders.
  • •Progressive neuromuscular diseases.
  • •Severe orthopedic problems with a significant impact on daily activities.

结局指标

主要结局

Berg Balance Scale (BBS)

时间窗: at baseline and after 8 weeks

Single Leg Stance test (SLS)

时间窗: at baseline and after 8 weeks

Timed Up and Go (TUG)

时间窗: at baseline and after 8 weeks

Activities Balance Confidence scale (ABC)

时间窗: at baseline and after 8 weeks

次要结局

  • Maximum inspiratory pressure (PI max)(Six minute walk distance)

研究者

发起方
Centre for physiotherapy and rehabilitation sciences Jamia Millia Islamia
申办方类型
Research institution

研究点 (2)

Loading locations...

相似试验