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临床试验/NCT02916849
NCT02916849已完成不适用

A Feasibility Study of an Intervention Using a Mobile Application to Promote Strength and Balance and Reduce Risk of Falls in Older People

Umeå University1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2016年9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
69
试验地点
1
主要终点
Adherence

研究概览

简要总结

This five arm feasibility study aims to promote self-management in strength and balance exercises among community-living older people. The research process, implementation strategies and procedures, acceptability of the exercise programs, perceived benefits of the programs, and the ecological validity, acceptability and ability to detect change of possible outcome measurements will be evaluated before a future randomized controlled trial. A comparison of two exercise programs will be performed; a) Safe Step, a mobile technology based exercise program with motivational strategies, developed by researchers in collaboration with older adults, and b) Otago Exercise Program (OEP), home exercises presented in a booklet. The older participants will be free to select either of the intervention programs and the selection process and outcome will be studied as part of the process evaluation.

The participants in three of the arms (OEP, Safe Step, and Safe Step with mentors) will be recruited through advertisements in local papers and through posters and meetings at senior citizens organisations. In the fourth and fifth arms (OEP and Safe Step) the participants will be recruited from health care centres and their registered professionals with experience of greens prescriptions (Fysisk aktivitet på recept). All five groups, with at least 10 participants in each, will be exercising for four months and will undergo testing at baseline, after two and four months and they will be asked to keep an exercise diary (digital or paper format) during the intervention.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Independently living
  • •Able to rise from a high chair
  • •Able to stand without support
  • •Experience an impaired balance

排除标准

  • •Progressive disease that impairs mobility
  • •Dementia diagnosis
  • •Intense exercising more than 3 hours / week

研究组 & 干预措施

Safe Step - Health Care Centre

Experimental

Participants will be recruited informed and asked for participation in the study by health care professionals. If included in the study, and choosing the Safe Step exercise program as intervention, participants will be given a green prescription for exercise using the application Safe Step. After an introduction meeting in small groups and pre-assessments the participants will create an individual exercise programme containing ten balance and leg strengthening exercises in the application. During the four month intervention the participants will create weekly exercise plan, keep a digital exercise diary, and receive motivational feed-back within the system. The participants will be recommended to exercise at least three times per week and for at least 30 minutes at a time.

干预措施: Safe Step (Other)

OEP - Health Care Centre

Active Comparator

Participants will be recruited informed and asked for participation in the study by health care professionals. If included in the study, and choosing the Otago Exercise Program as intervention in the study participants will be given a green prescription for exercise with the Otago Home Exercise Programme-booklet. After an introduction meeting in small groups and pre-assessments the participants will create an individual exercise programme containing ten balance and leg strengthening exercises using the booklet for guidance. During the four month intervention the participants will keep a paper-based exercise diary that will be sent to the researchers on a monthly basis. The participants will be recommended to exercise at least three times per week and for at least 30 minutes at a time.

干预措施: OEP (Other)

Safe Step - Advertising

Experimental

Participants are recruited through meetings at senior citizens organisations and interviewed by telephone for background data and choice of intervention before inclusion. After an introduction meeting in small groups and pre-assessments the participants will create an individual exercise programme containing ten balance and leg strengthening exercises in the Safe Step application. During the four month intervention the participants will create weekly exercise plan, keep a digital exercise diary, and receive motivational feed-back within the system. The participants will be recommended to exercise at least three times per week and for at least 30 minutes at a time

干预措施: Safe Step (Other)

Safe Step mentors- Advertising

Experimental

This arm is exactly the same as the Safe Step Advertising group except the participants will be invited to attend group meetings with peer mentors, once a month during the intervention. The peer mentors are older adults earlier involved in the research project . They will act as role models and encourage the participants throughout the four months of exercise.

干预措施: Safe Step (Other)

OEP - Advertising

Active Comparator

Participants are recruited through meetings at senior citizens organisations and interviewed by telephone for background data and choice of intervention before inclusion. After an introduction meeting in small groups and pre-assessments the participants will create an individual exercise programme containing ten balance and leg strengthening exercises using the Otago booklet for guidance. During the four month intervention the participants will keep a paper-based exercise diary that will be sent to the researchers on a monthly basis. The participants will be recommended to exercise at least three times per week and for at least 30 minutes at a time.

干预措施: OEP (Other)

结局指标

主要结局

Adherence

时间窗: after 4 month

adherence to the program from baseline to four months

次要结局

  • Change: Late-Life Function and Disability Instrument (LLFDI)(baseline and four month)
  • Change: Attitudes to Falls-Related Interventions Scale (AFRIS)(baseline, two month and four month)
  • Change: Behavioural Regulation In Exercise Questionnaire (BREQ-2)(baseline, two month and four month)
  • Change: 30 second chair-stand(baseline and four month)
  • Usability of the programs(Up to four months)
  • Change: Iconographical Falls Efficacy Scale (Icon-FES)(baseline and four month)
  • Change: Activity Specific Balance Confidence Scale (ABC)(baseline and four month)
  • Change: Short Physical Performance Battery(baseline and four month)
  • Uptake(baseline)

研究者

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

Marlene Sandlund

Assistant Professor

Umeå University

研究点 (1)

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