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건강한 활동은 삶을 향상시킵니다(HAIL) (HAIL)

2026년 11월 9일 업데이트: Louisa Grandin Sylvia, Massachusetts General Hospital

건강한 활동은 삶을 향상시킵니다. 무작위 대조 시험

The investigators have developed an online platform to support the 8-week, F&S! exercise program called the Healthy Activity Improves Lives (HAIL) online platform. The aim of this study is to perform a cluster randomization of four racially diverse churches or senior centers to either the standard F&S! program, or the combined HAIL Online Platform + F&S! program to examine the efficacy of the HAIL online platform + F&S! program for older adults in black communities.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

This is randomized clinical trial of cluster randomization evaluating the efficacy and feasibility of the HAIL online platform + F&S! program. We will enroll four cohorts (i.e., at two racially diverse churches or senior centers) for a total number of 120 participants. We will use a phone screen to assess participants' eligibility and explain the study procedures. Eligible individuals will then be given a link to complete an e-Consent in REDCap. Those randomized into the intervention group will also receive instructions on how to access the HAIL online platform to complete assessments as part of the baseline visit. Participants in both the intervention and comparison groups will complete the 8-week F&S! exercise program which will be delivered in-person as well as remote. Participants in the intervention group will have access to the adjunct HAIL online platform during the F&S! program, and then continue to use the HAIL online platform during the 3-mo follow-up.

연구 유형

중재적

등록 (실제)

116

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Massachusetts
      • Boston, Massachusetts, 미국, 02131
        • Roslindale Baptist Church

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

55년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Individuals over the age of 55 years
  • Participants are able to travel to one of the churches for the in-person F&S! exercise sessions
  • Participants cannot be currently participating in a regular PA program (i.e., at least 100 min per week of moderate to vigorous physical activities)

Exclusion Criteria:

  • Participants do not understand study procedures or are unable to participate in the verbal consent process
  • Participants must have a physician responsible for their medical care
  • Participants endorse an item on the Revised Physical Activity Readiness Questionnaire (rPAR-Q) as confirmed by their treating physician
  • Participants who report any contraindication to exercising (e.g., recent ECG changes or myocardial infarction, unstable angina, uncontrolled arrhythmias, third degree heart block, congestive heart failure)
  • Participants who receive a score of 28 or higher on the Telephone Interview for Cognitive Status (TICS) during pre-screening

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: HAIL Online Platform + Fit and Strong! Program

Participants (N=60) will be recruited from two racially diverse churches or senior centers (30 participants per church/center) to examine the efficacy of the HAIL Online platform + F&S! program for older adults in black communities. Participants will complete the 8-week F&S! exercise program (with access to the adjunct HAIL online platform), which will be delivered in-person as well as remote, and then continue to use the HAIL online platform during the 3-mo follow-up.

The HAIL online platform was developed based on feedback from our focus groups with older adults affiliated with BMA churches (conducted per IRB Protocol 2020P003100). Specifically, the HAIL online platform has a landing page where participants can access the links to the F&S! exercise sessions, complete the exercise log, obtain tips from an exercise instructor, as well as view study announcements. The landing page has a navigation bar on the left to access 1) the study assessments; 2) the F&S! exercise program participant manual; and 3) information on how to contact study staff. The goal of this adjunctive HAIL online platform is to support the continuation of exercise in the follow-up period once the 8-week F&S! exercise program is over. We conducted an open trial (per IRB protocol 2022P001782) to assess the feasibility and acceptability of the HAIL online platform adjunct to the F&S! program, which yielded positive results.

The Fit and Strong! Program (F&S!) is an exercise program for older adults developed by a study consultant, Dr. Susan Hughes, with funding from the National Institute of Aging. It is tailored for the unique needs of older, underserved adults and targets modifiable factors depicted by the socioecological model is necessary. The F&S! exercise program assists older adults to improve strength and functioning.

활성 비교기: Fit and Strong! Program

Participants (N=60) will be recruited from two racially diverse churches or senior centers (30 participants per church/center) to examine the feasibility and acceptability of the HAIL Online platform. Participants will complete the 8-week F&S! exercise program (without access to the adjunct HAIL online platform), which will be delivered in-person as well as remote, and then complete the 3-mo follow-up.

The Fit and Strong! Program (F&S!) is an exercise program for older adults developed by a study consultant, Dr. Susan Hughes, with funding from the National Institute of Aging. It is tailored for the unique needs of older, underserved adults and targets modifiable factors depicted by the socioecological model is necessary. The F&S! exercise program assists older adults to improve strength and functioning.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Feasibility and Retention
기간: Week 20

Retention will be assessed by how many individuals completed the 3-month post-intervention follow-up

Week 20
Acceptability
기간: Week 8

Acceptability will be assessed by the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 assesses acceptability and feasibility of the HAIL online platform and has demonstrated good reliability and validity. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.

Week 8
Acceptability (Feedback Form)
기간: Week 20

Acceptability will be assessed by the HAIL online Feedback form. We will develop a form to ask for tailored feedback on the F&S! program and the HAIL online platform to better understand participants' satisfaction with specific aspects of this online program.

Week 20
Acceptability (Exit Interviews)
기간: Week 20

Acceptability will finally be assessed with focus group exit interviews, which will be qualitatively coded.

Week 20

2차 결과 측정

결과 측정
측정값 설명
기간
Changes in Physical Activity (Steps)
기간: Weeks 0, 8, 20

Changes in physical activity will be measured by Participants' daily step counts. This outcome will be measured via the GT3X ActiGraph accelerometer.

Weeks 0, 8, 20
Changes in Physical Activity (MVPA)
기간: Weeks 0, 8, 20

Changes in physical activity will be measured by participants' daily number of minutes of moderate to vigorous physical activity (MVPA). This outcome will be measured via the GT3X ActiGraph accelerometer.

Weeks 0, 8, 20
Changes in Aerobic Capacity
기간: Weeks 0, 8, 20

This outcome will be measured via the 6 minute Walk Test.

Weeks 0, 8, 20
Changes in Physical Strength
기간: Weeks 0, 8, 20

This outcome will be measured via the Timed-Stands Test.

Weeks 0, 8, 20
Motivation to Change
기간: Week 0

Motivation to change outcome will be measured via the Readiness for Change Form. This is used to measure participants' motivation to participate in exercising. A high score indicates the respondent is more interested in participating in exercise activities. A low score indicates the respondent is less interested in participating in exercise activities.

Week 0
Utilization of Healthcare Resources
기간: Week 0

Utilization of healthcare resources outcome will be assessed via the Healthcare Utilization Form. This a descriptive measure used to assess utilization of healthcare resources in the past 6 months, and to better characterize the sample based on the number of comorbid conditions present. There is no scoring or total score.

Week 0
Fall History
기간: Week 0

Fall history outcome will be measured via the Fall History Form. This form is used to assess the history of falling within the past two years in participants.

Week 0
Chronic Conditions
기간: Week 0

Chronic conditions outcome will be measured via the Geri-AIMS. This is a19-item self-administered questionnaire adapted from the Arthritis Impact Measurement Scales (AIMS) for use with frail elderly respondents. The questionnaire assesses the presence of existing chronic medical conditions.

Week 0
Changes in Overall Wellbeing
기간: Weeks 0, 8, 20

Wellbeing will be measured via the WHO(Five) Well-Being Index (WHO-5). This is a reliable psychometric measure that predicts depression. The questionnaire consists of five items that assess predictors of depressive symptoms: positive mood, energy and interest. The raw score is calculated by totaling the figures of the five answers. The raw score ranges from 0 to 25, 0 representing worst possible and 25 representing best possible quality of life.

Weeks 0, 8, 20
Changes in Depression
기간: Weeks 0, 8, 20

Depression outcome will be measured via the Patient Health Questionnaire (PHQ-9). This is a 9-item, standardized and validated questionnaire that assesses the prevalence and severity of depression based on the DSM-5 criteria. The raw score ranges from 0 to 27, 1 representing minimal depression and 27 representing severe depression.

Weeks 0, 8, 20
Changes in Anxiety
기간: Weeks 0, 8, 20

Anxiety outcome will be measured via the Generalized Anxiety Disorder 7-item (GAD-7) scale. This is a 7-item anxiety scale with good reliability, as well as criterion, construct, factorial, and procedural validity. The raw score ranges from 0 to 21. Increasing scores are associated with multiple domains of functional impairment. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.

Weeks 0, 8, 20
Changes in Physical Functioning
기간: Weeks 0, 8, 20

Physical function outcome will be measured via the Patient-Reported Outcomes Measurement Information-Physical Functiong. This is an 8-item scale assessing coordination, functional mobility, strength and upper extremity function. The raw score ranges from 0 to 40. Increasing scores are associated with higher physical functioning.

Weeks 0, 8, 20
Changes in Social Isolation
기간: Weeks 0, 8, 20

Social isolation outcome will be measured via the Patient-Reported Outcomes Measurement Information Short Form- Social Isolation 4. This is a 4-item scale used to capture participants' perception of being left out and disconnected from others. The raw score ranges from 0 to 20. Increasing scores are associated with higher feelings of social isolation.

Weeks 0, 8, 20
Changes in Confidence in Exercises
기간: Weeks 0, 8, 20

Exercise confidence outcome will be measured via the Exercise Confidence Form. This is a 4-item questionnaire used to assess confidence in doing certain physical activities. The raw score ranges from 0 to 40. Increasing scores are associated with higher confidence in exercise.

Weeks 0, 8, 20

기타 결과 측정

결과 측정
측정값 설명
기간
Satisfaction with program
기간: Week 8

This outcome will be measured via the Client Satisfaction Questionnaire (CSQ-8). Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.

Week 8
Satisfaction with program
기간: Week 20

This outcome will be measured via the Client Satisfaction Questionnaire (CSQ-8). Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.

Week 20
Use of online program
기간: Week 8

This outcome will be assessed via the F&S! Program feedback from. This form consists of 8 questions and a semistructured exit interview of 4 questions. There is no scoring or total score.

Week 8
Use of online program
기간: Week 20

This outcome will be assessed via the F&S! Program feedback from. This form consists of 8 questions and a semistructured exit interview of 4 questions. There is no scoring or total score.

Week 20

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 4월 23일

기본 완료 (실제)

2025년 12월 29일

연구 완료 (실제)

2026년 2월 1일

연구 등록 날짜

최초 제출

2024년 1월 30일

QC 기준을 충족하는 최초 제출

2024년 2월 12일

처음 게시됨 (실제)

2024년 2월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 9일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2023P003522

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .