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临床试验/NCT06651385
NCT06651385
已完成
不适用

Pilot of Exercise and Asthma Control

University of Vermont1 个研究点 分布在 1 个国家目标入组 20 人2024年10月1日
适应症AsthmaObesity

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Asthma
发起方
University of Vermont
入组人数
20
试验地点
1
主要终点
The primary objective of this study is to determine the feasibility and acceptability of a remote digital therapeutic exercise program in people with obesity and poorly controlled asthma.
状态
已完成
最后更新
上个月

概览

简要总结

This will be a pilot, single arm, un-blinded study of a remote digital therapeutic exercise program in adults with obesity and poorly controlled asthma. Participants will be recruited from the University of Vermont Medical Center adult Pulmonary Clinic, Internal Medicine Clinic, and from the greater community via flyers and referrals, as needed. The primary outcome of interest will be the feasibility and acceptability of a remote digital therapeutic exercise program using a mobile application, called Vitala. Vitala is a FDA Registered, HIPAA Compliant CE-marked MDR class 1 medical device developed by doctors and physiotherapists. It is a mobile application tool that enables health care providers to prescribe and monitor diagnosis-specific exercise prescriptions that allows patients to remotely access their tailored therapeutic exercise program. URL: Medical exercise and digital rehabilitation - Vitala

Feasibility and acceptability will be defined as ≥60% of subjects enrolled in the exercise program completing, on average, ≥50% (≥75 minutes/ week) of the digital exercise program during their 12-week period, respectively. The secondary outcome of interest will be the efficacy of a remote digital therapeutic exercise program in participants with obesity and poorly controlled asthma by comparing asthma symptoms before, during, and at the end of the intervention. Efficacy will be defined as ≥30% of subjects who achieving a minimal clinically important difference in Asthma Control Test scores (defined as increase of ≥3 points[31]).

The Investigators plan to enroll participants on a rolling basis. Prospective participants will be contacted by phone, mail, or e-mail to establish interest and eligibility in the study. Once confirmed interested and eligible to participate in the study, they will be scheduled for eConsent and enrollment in the study (V0). Participants will receive a tailored exercise prescription unique to their individual needs, space, and available equipment and will be encouraged to complete 150 minutes of activity per week via their customized exercise program through the Vitala platform remotely for 12 weeks. Participants will be contacted when the program has been made available to them for program start, which will also be guided based on the participant's availability and preferred program start date (P0). During the 12 week exercise program, participants will have 3 remote contacts/visits (RC, V1, and 2), approximately every 4 - 6 weeks, over the 12 week intervention period including a final remote visit (V2) after completion of the program to assess adherence to the program, asthma control, and asthma-related quality of life.

注册库
clinicaltrials.gov
开始日期
2024年10月1日
结束日期
2025年12月19日
最后更新
上个月
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Principal Investigator
主要研究者

Mariel Sullivan

Principal Investigator

University of Vermont

入排标准

入选标准

  • Physician diagnosis of asthma on regular prescribed controller therapy for 3 months prior to enrollment (per EMR or self-report)
  • Age: ≥18 years of age
  • Obese: BMI ≥30 kg/m2
  • Poorly controlled asthma (defined as one or more of the following criteria:
  • Asthma Control Test Score ≤19, or
  • Use of rescue inhaler on average \>2 uses/week for preceding month, or
  • Nocturnal asthma awakening on average ≥1 times/week in preceding month, or
  • ED/hospital visit or prednisone course for asthma in past six months
  • Ability and willingness to provide informed consent
  • Internet access on a mobile smart phone to access the digital exercise program

排除标准

  • Any condition that precludes participation in regular exercise as judged by the investigator and/or study physician
  • Pregnancy (by self-report)
  • Active participation in another exercise or weight loss program, or within 30 days prior to enrollment
  • Current use of prescription weight loss medication, or within 30 days or 5- half lives, whichever is longer, prior to enrollment.
  • Failing to meet criteria on the PAR-Q+ screening questionnaire for safe exercise \[32, 33\]

结局指标

主要结局

The primary objective of this study is to determine the feasibility and acceptability of a remote digital therapeutic exercise program in people with obesity and poorly controlled asthma.

时间窗: 12 weeks

Successful feasibility will be defined as ≥60% of subjects enrolled in the exercise program completing, on average, ≥50% (≥75 minutes/ week) of the digital exercise program during their 12-week period.

研究点 (1)

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