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临床试验/NCT05767372
NCT05767372已完成不适用

Effect of Coherent Breathing on Different Outcome Measures in Elderly

Cairo University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
The Geriatric Depression Scale (GDS)

研究概览

简要总结

This study will be carried out on sixty elderlies of both gender with ages ranges from 60 to 70 years old. The participants will receive Inspiratory muscle trainer and/or Coherent breathing exercise three times per week for 12 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
60 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elderly subject of both gender with age ranged from 60 to 70 years old.
  • BMI will be ranged from 25 to 29.
  • Clinically and medically stable.
  • Able to understand the requirements of the study.
  • Conscious patient and respond to verbal command.

排除标准

  • Neurological conditions (e.g., stroke history, Parkinson's disease).
  • Presence of an acute illness.
  • Metabolically unstable chronic illness.
  • Pre-existent untreated metabolic or renal disease.
  • Patient undergoes chemotherapy.
  • Recent surgery.
  • Uncontrolled diabetes or hypertension.

结局指标

主要结局

The Geriatric Depression Scale (GDS)

时间窗: 12 weeks

Evaluating psychological aspect Of the 15 items, 10 indicated the presence of depression when answered positively, while the rest (question numbers 1, 5, 7, 11, 13) indicated depression when answered negatively. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.

The 6 minutes' walk test (6MWT)

时间窗: 12 weeks

Evaluating aerobic fitness

Short form Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)

时间窗: 12 weeks

Evaluating cognitive decline * Minimum score: 16 * Maximum score: 80 * High score means worse outcome.

Tinetti Performance Oriented Mobility Assessment (POMA)

时间窗: 12 weeks

Evaluating tests of balance and gait Description: The Tinetti assessment tool is an easily administered task-oriented test that measures an older adult's Scoring: A three-point ordinal scale, ranging from 0-2. "0" indicates the highest level of impairment and "2" the individuals independence. Total Balance Score = 16 Total Gait Score = 12 Total Test Score = 28 Interpretation: 25-28 = low fall risk 19-24 = medium fall risk \< 19 = high fall risk

The five Times Sit to Stand Test

时间窗: 12 weeks

Evaluating fall risk

The muscle quality index (MQI)

时间窗: 12 weeks

Evaluating age-related alterations in muscle function

Evaluation of oxygen saturation (SPO2) and heart rate (HR)

时间窗: 12 weeks

By using the pulse oximeter.

次要结局

  • Evaluation of forced expiratory volume at one second (FEV1) and maximum voluntary ventilation (MVV)(12 weeks)
  • Modified Borg Dyspnoea Scale(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rana Elbanna

lecturer at faculty of physical therapy at Cairo University

Cairo University

研究点 (2)

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