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临床试验/NCT03796039
NCT03796039已完成不适用

Stand if You Can- A Randomized Control Trial

University of New Brunswick1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2019年4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
97
试验地点
1
主要终点
Changes in Walking Speed

研究概览

简要总结

It is currently unknown if reducing sitting time, an activity that is highly prevalent in frail older adults living in long term care (LTC) facilities, is associated with an improvement in physical capacity such as walking speed. Simple tasks such as walking speed is associated with important outcomes for residents in LTC such as autonomy and hospitalization. The investigators hypothesize that standing an additional 100 minutes per week for 5 months will result in a clinically meaningful improvement in walking speed (0.1m/sec) in LTC residents compared to residents receiving a sitting social activity.

详细描述

LTC facilities from Moncton and Fredericton will be recruited, with half of the LTC facilities randomized as the intervention and half as the control group. The investigators are aiming to enrol half of the LTC in Fredericton and half in Moncton. A total of 88 residents (44 in the control group, 44 in the intervention group) will be enrolled in the program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

盲法说明

Investigator was masked at pre-testing. It was unknown which participants would be receiving the intervention. However, due to resources this was not repeated at post testing

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Resident at one of the selected LTC facilities;
  • •Able to provide consent or have a power of attorney agree on behalf of a resident to participate in the study;
  • •Able to walk for ten meters, with or without a walking aid; The main outcome is walking speed performed for a distance of 10 meters. Therefore, we want everyone who participates in the study to be able to complete the test at baseline. This way we can answer the main research question, while adhering to our sample size calculation.

排除标准

  • •If Identified by staff at the facility as too high risk for falling by participating in the intervention.

研究组 & 干预措施

Standing and Social Intervention

Experimental

Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.

干预措施: Standing (Behavioral)

Control Group

No Intervention

Control group will receive social visits, but no exposure to standing

结局指标

主要结局

Changes in Walking Speed

时间窗: Pre and post intervention testing

Measured by the 10m walking speed test

次要结局

  • Change in Balance(Pre and post testing (following the 5 month intervention). Data was collected but investigators are still analyzing findings.)
  • Change in Anxiety Symptoms(Pre-Post Testing (following the 5 month intervention))
  • Metabolic Profile - Low Density Lipoprotein Cholesterol(Pre-Post intervention (before and after 5-month intervention))
  • Metabolic Profile - High Density Lipoprotein Cholesterol(Pre and post testing (before and after the 5-month intervention))
  • Change in Leg Strength(Pre-Post Testing (following the 5 month intervention))
  • Depression(Pre-Post Testing (following the 5 month intervention))
  • Loneliness(Pre-Post Testing (following the 5 month intervention))
  • Social Behaviours(Pre-Post Testing (following the 5-month intervention). Data has been collected, but is still being analyzed)
  • Rate of Falls(The number of falls will be collected from three timeframes: 1. Between 6 months prior to and the start of program 2. the duration of the program (5 months) 3. From the end of the program to 6 months follow up. Data is still being analyzed at this time.)
  • Change Lower Limb Power(Pre-Post Testing (following the 5 month intervention))
  • Fall Efficacy(Pre-Post Testing (following the 5 month intervention))
  • Metabolic Profile - Triglycerides(Pre-Post Testing (before and following the 5 month intervention).)
  • Metabolic Profile - Blood Glucose(Pre-Post Intervention (before and after 5-month intervention))

研究者

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

Danielle Bouchard

Associate Investigator

University of New Brunswick

研究点 (1)

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