Exploring Resistance Exercise Training Plus High-Intensity Interval Training (ReHIIT) as Cancer Prehabilitation (ReHIIT_CON)

December 16, 2025 updated by: University of Nottingham

Exploring Resistance Exercise Training Plus High-Intensity Interval Training (ReHIIT) as Cancer Prehabilitation: A Healthy Control Group Pilot Study

Colorectal cancer is the fourth most common cancer in the UK. Prehabilitation, including exercise, can improve recovery from surgery. This pilot study investigates the combined effects of resistance and high-intensity interval training (ReHIIT) in healthy adults to establish baseline physiology and responses for comparison with cancer patients

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Colorectal cancers are a leading cause of death in the UK, but many can be cured with surgery alone. From diagnosis to surgery or alternative first treatment, the UK government mandates a maximum timeline of 31 days, providing only a short window in which patients may be physically optimised by exercise before surgery. There is increasing interest in clinical and academic settings regarding the potential benefits of exercise-based surgical prehabilitation. Although surgery is often successful, the combined effects of cancer and surgical stress can lead to poor clinical and patient-centred outcomes, including delayed return to normal activities and reduced quality of life. Physiological parameters known to be improved through exercise training, such as cardiorespiratory fitness and muscle mass, have been associated with more favourable clinical outcomes for individuals undergoing colorectal cancer surgery, including anaesthetic risk and tolerance to adjuvant treatment.

The limited time available before surgery remains a major challenge. Traditional modes of exercise training, including aerobic and resistance exercise performed separately, typically require six weeks or more to produce meaningful improvements in their primary physiological adaptations. As a result, recent cancer rehabilitation research has increasingly used high-intensity interval training (HIIT) because it requires less time and has been shown to improve both cardiorespiratory fitness and muscle mass more rapidly than traditional exercise modalities.

Although HIIT has demonstrated potential in several patient groups, previous work has shown that individuals with colorectal cancer may not experience improvements in cardiorespiratory fitness or muscle mass after a four-week HIIT intervention, even though the same protocol has produced adaptations in older adults and individuals with other cancer types. This may reflect a degree of anabolic or physiological resistance in the colorectal cancer population. Based on this, a current trial is comparing HIIT alone with a combined approach of HIIT plus resistance exercise training (ReHIIT) to determine whether the addition of resistance exercise can overcome this reduced adaptive response.

However, the expected magnitude of physiological adaptation to four weeks of ReHIIT in adults without cancer has not been fully characterised. This study will therefore explore changes in cardiorespiratory fitness, muscle mass, and associated metabolic and molecular mechanisms in healthy adults following a four-week ReHIIT programme.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
    • Derbyshire
      • Derby, Derbyshire, United Kingdom, DE223DT
        • Medical School, University of Nottingham, Royal Derby Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Availability and willingness to attend the Royal Derby Hospital site for a minimum of 8 exercise sessions and 2 assessment sessions across the study period.

Exclusion Criteria:

  • BMI <18 or >35 kg/m2
  • Known active cance
  • Known metabolic disease
  • Current known neurological or musculoskeletal conditions (e.g. epilepsy)
  • Active known cardiovascular, cerebrovascular or respiratory disease - e.g:
  • Uncontrolled hypertension (systolic BP > 160 mmHg or diastolic BP >100 mmhg)
  • Myocardial infarction within the last 6 months or unstable angina
  • Heart failure (New York Heart association Class III/IV)
  • Arrhythmia
  • Right to left cardiac shunt
  • Aneurysm of a named blood vessel
  • COPD
  • Pulmonary hypertension
  • Exercise-induced or brittle asthma
  • Previous stroke/transient ischaemic attack
  • Abnormal ECG results (at the discrepancy of the study doctor)
  • Patients who are unable to undergo CPET based on ATS/ACSS guidelines ^
  • Pre-existing clotting disorder known to the participant or anticoagulant use
  • Family history of severe bleeding requiring medical intervention
  • Participation in a research study in the last 3 months involving invasive procedures or an inconvenience allowance (ALL UoN FMHS UREC approved studies)
  • Pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Resistance exercise training plus high-intensity interval training (ReHIIT) Intervention
Participants will complete 8-12 supervised sessions combining high-intensity interval cycling and resistance training at 70% 1-RM.
Other: ReHIIT Training Intervention
Participants will complete 8-12 supervised sessions combining high-intensity interval cycling (5 × 1-minute intervals at 110% CPET wattage, with 90-second rest intervals) and resistance training at 70% 1-RM (3 sets of 8-12 repetitions, 6 exercises).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in anaerobic threshold (CPET-derived)
Time Frame: From baseline to 4-weeks after the start of the intervention
From baseline to 4-weeks after the start of the intervention
Change in Muscle mass
Time Frame: From baseline to 4-weeks after the start of the intervention
Derived from DXA and stable isotope assessments of muscle mass (COSIAM, Cegielski et al., 2021)
From baseline to 4-weeks after the start of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nottingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Professor Bethan E Phillips, University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FMHS 237-0925

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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