Physical ActivityHAILNCT05670223
Healthy Activities Improve Lives
A study testing Fit&Strong Exercise Program in people with Physical Activity, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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 aims of this study are to conduct an open pilot trial with exit interviews (N=30) of the HAIL online platform in two racially diverse churches to… Read more about this study
- Who is it for?
- Ages 60 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Fit&Strong Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals over the age of 60 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 (physical activity) program (i.e., at least 100 min per week of moderate to vigorous physical activities)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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 aims of this study are to conduct an open pilot trial with exit interviews (N=30) of the HAIL online platform in two racially diverse churches to evaluate its feasibility and acceptability (Hypothesis 1) as well as explore its efficacy (Hypothesis 2).
Read the detailed description
This is an open pilot study to evaluate the feasibility and accessibility of the HAIL online platform. This study will enroll two cohorts (i.e., at two racially diverse churches) for a total number of 30 participants. This study 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 as well as instructions on how to access the HAIL online platform to complete assessments as part of the baseline visit. 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.
- Conditions
- Physical Activity
- Being tested
- Fit&Strong Exercise Program
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit&Strong Exercise ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Open Pilot Group | Experimental | Participants (N=30) will be recruited across two churches, MorningStar Baptist Church and People's Baptist Church, to examine the feasibility and acceptability of the HAIL Online platform. 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. Receives: Other: Fit&Strong Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Retention
Retention will be assessed by how many people completed the 3-month post-intervention follow-up
Measured: Week: 20
Acceptability
Acceptability will be assessed by:1) Client Satisfaction Questionnaire (CSQ-8), 2) F\&S! - online Feedback form, 3) Focus group exit interviews. The CSQ-8 assesses acceptability and feasibility of the F\&S!-Online program and has demonstrated good reliability and validity.
We will develop a form to ask for tailored feedback on the F\&S-Online program to better understand participants' satisfaction with specific aspects of this online program.
We will also conduct exit interviews with focus group and pilot study participants
Measured: Week: 0
Acceptability
Acceptability will be assessed by:1) Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 assesses acceptability and feasibility of the F\&S!-Online program and has demonstrated good reliability and validity.
Measured: Week: 8
Acceptability
Acceptability will be assessed by :1) Client Satisfaction Questionnaire (CSQ-8), 2) F\&S! - online Feedback form, 3) Focus group exit interviews. The CSQ-8 assesses acceptability and feasibility of the F\&S!-Online program and has demonstrated good reliability and validity. We will develop a form to ask for tailored feedback on the F\&S-Online program to better understand participants' satisfaction with specific aspects of this online program.
We will also conduct exit interviews with focus group and pilot study participants
Measured: Week: 20
Secondary outcomes (12)
Changes in Aerobic Capacity
This outcome will be measured via the 6 minute Walk Test.
Measured: Weeks: 0 , 8 , 20
Changes in Physical Strength
This outcome will be measured via the Timed-Stands Test.
Measured: Weeks: 0 , 8 , 20
Motivation to Change
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.
Measured: Weeks: 0
Utilization of Healthcare Resources
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.
Measured: Weeks: 0
Fall History
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.
Measured: Weeks: 0
Chronic Conditions
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.
Measured: Weeks: 0
Changes in Overall Wellbeing
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.
Measured: Weeks: 0, 8 , 20
Changes in Depression
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.
Measured: Weeks: 0, 8 , 20
Changes in Anxiety
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.
Measured: Weeks: 0, 8 , 20
Changes in Physical Functioning
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.
Measured: Weeks: 0, 8 , 20
Changes in Social Isolation
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.
Measured: Weeks: 0, 8 , 20
Changes in Confidence in Exercises
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.
Measured: Weeks: 0, 8 , 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start30 Sep 2022
- Primary completion30 Jun 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Louisa Grandin Sylvia, Massachusetts General Hospital
- Investigators
- Louisa Sylvia, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670223
- Sponsor's protocol ID
- 2022P001782
- Other IDs
- R21AG067091
- Acronym
- HAIL
- Status last verified
- Oct 2023
- First submitted
- 7 Dec 2022
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Activities Improve Lives
- ClinicalTrials.gov ID
- NCT05670223
- Acronym / sponsor ID
- HAIL / 2022P001782
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 aims of this study are to conduct an open pilot trial with exit interviews (N=30) of the HAIL online platform in two racially diverse churches to evaluate its feasibility and acceptability (Hypothesis 1) as well as explore its efficacy (Hypothesis 2).
Detailed description
This is an open pilot study to evaluate the feasibility and accessibility of the HAIL online platform. This study will enroll two cohorts (i.e., at two racially diverse churches) for a total number of 30 participants. This study 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 as well as instructions on how to access the HAIL online platform to complete assessments as part of the baseline visit. 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Pilot Group | Experimental | Other: Fit&Strong Exercise ProgramParticipants (N=30) will be recruited across two churches, MorningStar Baptist Church and People's Baptist Church, to examine the feasibility and acceptability of the HAIL Online platform. 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. |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals over the age of 60 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 (physical activity) program (i.e., at least 100 min per week of moderate to vigorous physical activities)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fit&Strong Exercise ProgramThe 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. | Other | Open Pilot Group |
Primary outcome
Feasibility and Retention
Time frame: Week: 20
Retention will be assessed by how many people completed the 3-month post-intervention follow-up
Acceptability
Time frame: Week: 0
Acceptability will be assessed by:1) Client Satisfaction Questionnaire (CSQ-8), 2) F\&S! - online Feedback form, 3) Focus group exit interviews. The CSQ-8 assesses acceptability and feasibility of the F\&S!-Online program and has demonstrated good reliability and validity. We will develop a form to ask for tailored feedback on the F\&S-Online program to better understand participants' satisfaction with specific aspects of this online program. We will also conduct exit interviews with focus group and pilot study participants
Acceptability
Time frame: Week: 8
Acceptability will be assessed by:1) Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 assesses acceptability and feasibility of the F\&S!-Online program and has demonstrated good reliability and validity.
Acceptability
Time frame: Week: 20
Acceptability will be assessed by :1) Client Satisfaction Questionnaire (CSQ-8), 2) F\&S! - online Feedback form, 3) Focus group exit interviews. The CSQ-8 assesses acceptability and feasibility of the F\&S!-Online program and has demonstrated good reliability and validity. We will develop a form to ask for tailored feedback on the F\&S-Online program to better understand participants' satisfaction with specific aspects of this online program. We will also conduct exit interviews with focus group and pilot study participants
12 secondary outcomes
Changes in Aerobic Capacity
Time frame: Weeks: 0 , 8 , 20
Changes in Physical Strength
Time frame: Weeks: 0 , 8 , 20
Motivation to Change
Time frame: Weeks: 0
Utilization of Healthcare Resources
Time frame: Weeks: 0
Fall History
Time frame: Weeks: 0
Chronic Conditions
Time frame: Weeks: 0
Changes in Overall Wellbeing
Time frame: Weeks: 0, 8 , 20
Changes in Depression
Time frame: Weeks: 0, 8 , 20
Changes in Anxiety
Time frame: Weeks: 0, 8 , 20
Changes in Physical Functioning
Time frame: Weeks: 0, 8 , 20
Changes in Social Isolation
Time frame: Weeks: 0, 8 , 20
Changes in Confidence in Exercises
Time frame: Weeks: 0, 8 , 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louisa Sylvia, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fit&Strong Exercise Program in people with Physical Activity, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Retention (time frame: Week: 20). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.