PrehabilitationNCT05377970
Implementation of a Prehabilitation Program for Surgical Patients
A study testing Thinkific Prehabilitation Exercise Program in people with Prehabilitation and Oncology, run by MaineHealth at 1 site in United States.
Trial summary
Frailty is a state of increased vulnerability to stressors with increased rates of poor outcomes. Surgery is one of these stressors, and previous research has therefore shown increased rates of morbidity and mortality in frail patients undergoing surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prehabilitation, Oncology, Surgical Oncology
- What is being tested?
- Thinkific Prehabilitation Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2022to 31 Jul 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects ≥18 years old
- Evaluated at Maine Medical Center by surgical oncology service
- Planned surgical intervention for gastrointestinal oncologic condition
- Score ≥40 on Risk Analysis Index frailty screening
- Physically able to participate in prehabilitation exercises
- Home internet access and established email account
- Able to understand the English language
Who cannot join
- Patients unable to participate in exercises included in prehabilitation program
- Patients with impaired decision making capacity
- Those in a high risk community: prisoners and pregnant women
- Those who do not meet the above inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Maine Medical Center
Portland, Maine, 04101
Timothy Fitzgerald
About this study
Official title: Implementation of a Prehabilitation Pilot Program for Individuals With Frailty Undergoing Oncologic Surgery
Frailty is a state of increased vulnerability to stressors with increased rates of poor outcomes. Surgery is one of these stressors, and previous research has therefore shown increased rates of morbidity and mortality in frail patients undergoing surgery. Prehabilitation programs can help mitigate the negative outcomes associated with frailty. The investigators hope to implement a newly developed prehabilitation pilot program in the Maine Medical Center Surgical Oncology Clinic to initially evaluate adherence, self-efficacy, and health-related quality of life.
Read the detailed description
Frailty is a state of increased vulnerability to stressors with increased rates of poor outcomes. Surgery is one of these stressors, and previous research has therefore shown increased rates of morbidity and mortality in frail patients undergoing surgery. Prehabilitation programs can help mitigate the negative outcomes associated with frailty. The investigators hope to implement a newly developed prehabilitation pilot program in the Maine Medical Center Surgical Oncology Clinic to initially evaluate adherence, self-efficacy, and health-related quality of life.
The investigators now hope to implement this prehabilitation program in the clinics at Maine Medical Center. Our long term goal is the introduce this program in all surgical specialties; but first, the investigators plan to assess adherence, patient self-efficacy, frailty and health-related quality of life through a pilot study in the surgical oncology clinic.
- Conditions
- Prehabilitation, Oncology, Surgical Oncology
- Being tested
- Thinkific Prehabilitation Exercise Program
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thinkific Prehabilitation Exercise ProgramOther
Prehabilitation exercise program through the Thinkific platform
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation Intervention Program | Experimental | Patients enrolled in this arm will receive the preabilitation intervention program prior to their surgery to complete Receives: Other: Thinkific Prehabilitation Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant adherence to prehab program
Evaluate adherence through analysis of patient maintained exercise logs via number of days completed
Measured: Through study completion, on average 3 months
Correlation between patient pre-program self-efficacy evaluation and measured adherence to study prehabilitation program
Assess self-efficacy by evaluating the relationship between pre-program Self-Efficacy for Home Exercise Program Scale (0-72) score and adherence.
Measured: Through study completion, on average 3 months
Patient Satisfaction
Assess patient satisfaction and barriers to adherence through a post prehab program survey.
Measured: Last day of prehabilitation program (within week prior to surgery)
Quality of Life (Short Form- 36 Survey)
Evaluate change in health-related quality of life before and after participation in the prehabilitation program.
Measured: Completed at Day 0, Two weeks, Four weeks and Last day of prehabilitation program (within week prior to surgery)
Frailty (Risk Analysis Index)
Evaluate change in frailty using Risk Analysis Index before and after participation in the prehabilitation program.
Measured: Evaluated on Day 0 and at last visit prior to surgery, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start25 Jun 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehabilitationStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MaineHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts Medical Center
- Responsible party
- Principal investigator, Laura Nicolais, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377970
- Sponsor's protocol ID
- 1855206
- Status last verified
- Oct 2023
- First submitted
- 8 Apr 2022
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Prehabilitation Pilot Program for Individuals With Frailty Undergoing Oncologic Surgery
- ClinicalTrials.gov ID
- NCT05377970
- Acronym / sponsor ID
- 1855206
- Conditions
- Prehabilitation, Oncology, Surgical Oncology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- MaineHealthUniversity, hospital or other
- Collaborators
- Tufts Medical Center
- Study start
- 25 Jun 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 17 May 2022 (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.
Frailty is a state of increased vulnerability to stressors with increased rates of poor outcomes. Surgery is one of these stressors, and previous research has therefore shown increased rates of morbidity and mortality in frail patients undergoing surgery. Prehabilitation programs can help mitigate the negative outcomes associated with frailty. The investigators hope to implement a newly developed prehabilitation pilot program in the Maine Medical Center Surgical Oncology Clinic to initially evaluate adherence, self-efficacy, and health-related quality of life.
Detailed description
Frailty is a state of increased vulnerability to stressors with increased rates of poor outcomes. Surgery is one of these stressors, and previous research has therefore shown increased rates of morbidity and mortality in frail patients undergoing surgery. Prehabilitation programs can help mitigate the negative outcomes associated with frailty. The investigators hope to implement a newly developed prehabilitation pilot program in the Maine Medical Center Surgical Oncology Clinic to initially evaluate adherence, self-efficacy, and health-related quality of life.
The investigators now hope to implement this prehabilitation program in the clinics at Maine Medical Center. Our long term goal is the introduce this program in all surgical specialties; but first, the investigators plan to assess adherence, patient self-efficacy, frailty and health-related quality of life through a pilot study in the surgical oncology clinic.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation Intervention Program | Experimental | Other: Thinkific Prehabilitation Exercise ProgramPatients enrolled in this arm will receive the preabilitation intervention program prior to their surgery to complete |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects ≥18 years old
- Evaluated at Maine Medical Center by surgical oncology service
- Planned surgical intervention for gastrointestinal oncologic condition
- Score ≥40 on Risk Analysis Index frailty screening
- Physically able to participate in prehabilitation exercises
Key exclusion criteria (4 listed)
- Patients unable to participate in exercises included in prehabilitation program
- Patients with impaired decision making capacity
- Those in a high risk community: prisoners and pregnant women
- Those who do not meet the above inclusion criteria
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 |
|---|---|---|
| Thinkific Prehabilitation Exercise ProgramPrehabilitation exercise program through the Thinkific platform | Other | Prehabilitation Intervention Program |
Primary outcome
Participant adherence to prehab program
Time frame: Through study completion, on average 3 months
Evaluate adherence through analysis of patient maintained exercise logs via number of days completed
Correlation between patient pre-program self-efficacy evaluation and measured adherence to study prehabilitation program
Time frame: Through study completion, on average 3 months
Assess self-efficacy by evaluating the relationship between pre-program Self-Efficacy for Home Exercise Program Scale (0-72) score and adherence.
Patient Satisfaction
Time frame: Last day of prehabilitation program (within week prior to surgery)
Assess patient satisfaction and barriers to adherence through a post prehab program survey.
Quality of Life (Short Form- 36 Survey)
Time frame: Completed at Day 0, Two weeks, Four weeks and Last day of prehabilitation program (within week prior to surgery)
Evaluate change in health-related quality of life before and after participation in the prehabilitation program.
Frailty (Risk Analysis Index)
Time frame: Evaluated on Day 0 and at last visit prior to surgery, an average of 3 months
Evaluate change in frailty using Risk Analysis Index before and after participation in the prehabilitation program.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thinkific Prehabilitation Exercise Program in people with Prehabilitation and Oncology, run by MaineHealth 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 7 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: status not confirmed, as of the sponsor's last update on 24 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Nicolais (207-662-2515, LNicolais@mmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant adherence to prehab program (time frame: Through study completion, on average 3 months). The study lists 5 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 24 Oct 2023; AzTrials last refreshed its copy on 1 Nov 2026.