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临床试验/NCT05697497
NCT05697497已完成不适用

A Brief Digital Exercise Program to Improve Physical Function Among Older Adults

Milton S. Hershey Medical Center1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2021年5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
102
试验地点
1
主要终点
30-Second Chair Stand

研究概览

简要总结

This study is a randomized trial of 100 older adults with mobility disability, who performed a similar brief daily, resistance training program. The investigators set out to answer the following question "Will a digital, brief daily exercise program be feasible, acceptable, and effective among older adults with walking limitations?" To answer that question, participants were assigned to an intervention or delayed-treatment control group. Intervention participants were assigned to complete two 30-second lower body exercises and two 30-second upper body exercises. Fitness tests were completed remotely three times during the 12-weeks (i.e., at baseline, week 6, week 12).

详细描述

This is a 12-week delayed-control randomized trial to answer the following question "Will a digital, brief daily exercise program be feasible, acceptable, and effective among older adults with walking limitations?" Participants who screen eligible will be assigned to one of four conditions, an immediate workout group, an immediate workout group with activity monitor, a delayed workout group or a delayed workout group with activity monitor. Participants will complete a daily 4-minute exercise routine at home and to record their results using an electronic survey. Other outcome measurements will be conducted remotely at baseline, 6, and 12 weeks.

The investigators hypothesize that participants in the AMRAP condition will report significant reductions in functional physical limitations, increased gait speed, and increased physical performance (i.e., increased exercise repetitions) from baseline to 6 weeks compared to those randomized to the delayed-treatment control.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • Age 65 and older
  • Difficulty with walking
  • Providers must provide consent for their patient
  • Access to the internet
  • Must have a camera on computer, tablet, or smartphone
  • Fluent in Egnlish

排除标准

  • Chest pain or a heart condition on the PAR-Q
  • Planning to have surgery in the next 3 months
  • Cognitive impairment
  • Unable to exercise
  • Being currently physically active

研究组 & 干预措施

Intervention Condition

Experimental

The exercise intervention consists of a 4 minute daily routine that includes 2 upper body and 2 lower body exercises.

干预措施: Daily exercise intervention (Behavioral)

Delayed-Treatment Control Group

No Intervention

The exercise intervention consists of a 4 minute daily routine that includes 2 upper body and 2 lower body exercises. Participants in the this arm will not start the exercise intervention until the day after the week 12 assessment.

结局指标

主要结局

30-Second Chair Stand

时间窗: 12 weeks

Leg strength and endurance test - number of chair stand repetitions in 30 seconds

Single Leg Stance Test (SLS)

时间窗: 12 weeks

Assessment of static postural and balance control.

Falls

时间窗: 12 weeks

Falls over the past 3 months will be assessed using the Behavioral Risk Factor Surveillance System survey.

Five Time Sit to Stand Test (5TSTS)

时间窗: 12 weeks

The Five Times Sit to Stand Test measures one aspect of transfer skill. The test provides a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements. The score is the amount of time (to the nearest decimal in seconds) it takes a patient to transfer from a seated to a standing position and back to sitting five times.

Functional limitations

时间窗: 12 weeks

Physical Functioning Questionnaire from the National Health and Nutrition Examination Survey

30-Second Chair Stand

时间窗: 6 weeks

Leg strength and endurance test - number of chair stand repetitions in 30 seconds

30-Second Chair Stand

时间窗: Baseline

Leg strength and endurance test - number of chair stand repetitions in 30 seconds

Five Time Sit to Stand Test (5TSTS)

时间窗: Baseline

The Five Times Sit to Stand Test measures one aspect of transfer skill. The test provides a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements. The score is the amount of time (to the nearest decimal in seconds) it takes a patient to transfer from a seated to a standing position and back to sitting five times.

Five Time Sit to Stand Test (5TSTS)

时间窗: 6 weeks

The Five Times Sit to Stand Test measures one aspect of transfer skill. The test provides a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements. The score is the amount of time (to the nearest decimal in seconds) it takes a patient to transfer from a seated to a standing position and back to sitting five times.

次要结局

  • Pain on the Patient Reported Outcomes Measurement Information System (PROMIS) survey(12 weeks)
  • Self-Efficay for Physical Activity (SEPA)(12 weeks)
  • Walking gait cadence(10 day period pre and post intervention)
  • Fatigue on the Patient Reported Outcomes Measurement Information System (PROMIS) survey(12 weeks)
  • Percent of sessions attended(12 weeks)
  • Heart rate(12 weeks)

研究者

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

Christopher Sciamanna, MD, MPH

Professor and Vice Chair for Research Affairs, Department of Medicine

Penn State Health Milton S Hershey Medical Center

研究点 (1)

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