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临床试验/NCT02695342
NCT02695342已完成不适用

Pilot Study of a Tailored Home Balance Exercise Program for Reducing Falls in Older Adults With COPD

McMaster University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Retention rate

研究概览

简要总结

There is a growing body of evidence demonstrating that older adults with COPD have important problems with their balance and a high incidence of falls compared to those of a similar age. This research will explore the feasibility and preliminary effects of a tailored 6-month home balance exercise program for reducing falls in older adults with COPD.

详细描述

Chronic obstructive pulmonary disease (COPD) is highly prevalent among older adults and is a leading cause of death, disability and hospitalization in Canada. There is a growing body of evidence demonstrating that older adults with COPD have important problems with their balance and a high incidence of falls compared to those of a similar age. This research will explore the feasibility and preliminary efficacy of a tailored 6-month home balance exercise program for reducing falls in older adults with COPD.

The primary objective of this pilot study is to determine the feasibility of a tailored home balance intervention for older adults with COPD in terms of recruitment, retention and adherence. The secondary objective is to examine the within-subject effects of the home-balance intervention on intermediate outcomes linked to falls including balance, functional strength and self-reported disability.

Thirty-five older adults with COPD will be recruited from respirology clinics at West Park Healthcare Centre (Toronto) and the Firestone Institute for Respiratory Health (Hamilton) to participate in a single-group, non-randomized clinical trial. Eligible participants will be enrolled in a 6-month balance home exercise intervention. The home program will be supervised by a physiotherapist and outcome measures will be collected at home at baseline, 3- and 6-months by a research assistant not involved in the intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •a clinical diagnosis of COPD;
  • •age ≥ 60 yrs;
  • •a history of 1 or more falls in the previous year;
  • •ability to provide written informed consent.

排除标准

  • •inability to communicate in English;
  • •history of significant cardiovascular disease;
  • •marked decrease in arterial oxygen saturation at rest or during previous assessments of exercise capacity;
  • •severe cognitive impairment;
  • •evidence of a condition that severely limits mobility and may jeopardize safety;
  • •completion of a course of rehabilitation in the last 6 months or on a wait list for admission to rehabilitation.

研究组 & 干预措施

Home balance exercise program

Experimental

The home-based exercise program will be tailored to address the underlying balance deficits in COPD and individualized according to each participant's ability. Physiotherapists will teach the program in four home visits over the first 6 weeks of the study; in the event of an exacerbation, a fifth visit will be provided to modify the program. Participants will be given an exercise DVD (with portable player), and will be instructed to perform the program 3 times/week for 6 months. Therapists will provide bi-monthly telephone support.

干预措施: Home balance exercise program (Behavioral)

结局指标

主要结局

Retention rate

时间窗: 6 months

Percentage of the sample that complete all 3 outcome assessments

Compliance

时间窗: 6 months

Mean number of prescribed exercise sessions completed

Recruitment rate

时间窗: Baseline

Percentage of eligible patients that consent to enroll in the study

次要结局

  • Balance Evaluation Systems Test (BESTest)(baseline, 3 months, 6 months)
  • Berg Balance Scale(baseline, 3 months, 6 months)
  • Self-reported function (PF-10)(baseline, 3 months, 6 months)
  • 30-second Sit-to-Stand Test(baseline 3 months, 6 months)
  • Activity-Specific Balance Confidence questionnaire(baseline, 3 months, 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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