ClinicalTrials.gg
Status unknownNCT05377970Updated Oct 24, 2023

Implementation of a Prehabilitation Program for Surgical Patients

An interventional study of Thinkific Prehabilitation Exercise Program in Prehabilitation, Oncology and Surgical Oncology, sponsored by MaineHealth. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-24.

Sponsored by MaineHealth · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Prehabilitation
  • Oncology
  • Surgical Oncology

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03

In context

Neoplasms

9,617 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 7,432 interventional studies indexed under Neoplasms.

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Lead sponsor

MaineHealth is the lead sponsor of 36 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subjects ≥18 years old
  2. Evaluated at Maine Medical Center by surgical oncology service
  3. Planned surgical intervention for gastrointestinal oncologic condition
  4. Score ≥40 on Risk Analysis Index frailty screening
  5. Physically able to participate in prehabilitation exercises
  6. Home internet access and established email account
  7. Able to understand the English language

Exclusion criteria

Exclusion Criteria:

  1. Patients unable to participate in exercises included in prehabilitation program
  2. Patients with impaired decision making capacity
  3. Those in a high risk community: prisoners and pregnant women
  4. Those who do not meet the above inclusion criteria
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Prehabilitation Intervention Program

    Patients enrolled in this arm will receive the preabilitation intervention program prior to their surgery to complete

    Other: Thinkific Prehabilitation Exercise Program

Interventions

  • OtherThinkific Prehabilitation Exercise Program

    Prehabilitation exercise program through the Thinkific platform

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What researchers measure

Primary outcomes

  1. Participant adherence to prehab program

    Evaluate adherence through analysis of patient maintained exercise logs via number of days completed

    Time frame: Through study completion, on average 3 months

  2. 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.

    Time frame: Through study completion, on average 3 months

  3. Patient Satisfaction

    Assess patient satisfaction and barriers to adherence through a post prehab program survey.

    Time frame: Last day of prehabilitation program (within week prior to surgery)

  4. Quality of Life (Short Form- 36 Survey)

    Evaluate change in health-related quality of life before and after participation in the prehabilitation program.

    Time frame: Completed at Day 0, Two weeks, Four weeks and Last day of prehabilitation program (within week prior to surgery)

  5. Frailty (Risk Analysis Index)

    Evaluate change in frailty using Risk Analysis Index before and after participation in the prehabilitation program.

    Time frame: Evaluated on Day 0 and at last visit prior to surgery, an average of 3 months

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Study locations

1 of 1 sites recruiting
  • Maine Medical Center
    Portland, Maine 04101, United States
    • Timothy Fitzgerald · Contact
    Recruiting
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References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 15, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2022 (actual). Primary completion is estimated for Jun 2024, 24 months after the start.

Of 1,358 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 71. This study's planned 24 months is below that.

Counting every sponsor, half of 1,404 studies reached it within 38 months; a quarter within 17 and three quarters within 71.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 8, 2022
First posted
May 17, 2022
StartActual
Jun 25, 2022
Primary completionEst.
Jun 30, 2024
CompletionEst.
Jul 31, 2024
Last update
Oct 24, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05377970
Lead sponsor
MaineHealth
Responsible party
Laura Nicolais (Timothy Fitzgerald: Associate Medical Director. Oncology, MaineHealth) — Principal investigator
First posted
May 17, 2022
Start date
Jun 25, 2022
Primary completion
Jun 30, 2024 (estimated)
Completion
Jul 31, 2024 (estimated)
Last update
Oct 24, 2023

Study contacts

Laura Nicolais
Contact
LNicolais@mmc.org
207-662-2515

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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