CancerNCT06039488
Effectiveness of a Cancer Exercise Program
A study testing Exercise in people with Cancer, run by University of South Carolina at 1 site in United States.
Trial summary
The investigators are examining the impact of an 8-week multi-modal exercise program (resistance and cardiovascular training) delivered 2 times per week on physical function adults (>18 years old) with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2021to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults > 18 diagnosed with cancer
Who cannot join
- unwilling to come to the on-site clinic for exercise sessions
- any neuromuscular, cardiovascular, or psychological condition precluding safe exercise
- unable to read/understand English.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of South Carolina
Columbia, South Carolina, 29205
About this study
Official title: The Impact of an 8-week Exercise Program on Physical Function in Individuals With Cancer
The investigators are examining the impact of an 8-week multi-modal exercise program (resistance and cardiovascular training) delivered 2 times per week on physical function adults (>18 years old) with cancer.
- Conditions
- Cancer
- Being tested
- Exercise
- Keywords
- Exercise
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
A combination of resistance exercise and cardiovascular exercise (performed 2 days per week for 8-weeks) is tailored to each individual in accordance with their medical/cancer-related history, baseline assessments of physical function, and overall goals.
Resistance exercise includes 6-8 exercises targeting major muscle groups. The first week of the program is used to familiarize participants to the exercises of the program, provide coaching on safe and appropriate technique, and identifying initial load for 2 sets of 12 repetitions (equivalent to ~65% 1 repetition maximum), with a goal of working towards 4 sets of 8 reps. Additionally, participants are asked to perform 20-30 minutes of moderate-to-vigorous aerobic activity (approximately 60-85% age-predicted heart rate maximum) via walking, jogging, or cycling each session.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 2 days/week of resistance and cardiovascular exercise for 8-weeks Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bellarmine Norton Assessment Tool (2-minute Step Test)
2-minute Step Test: Number of times an individuals' knee reaches a predetermined heigh during a 2-minute period of marching
Measured: 0 and 8-weeks
Bellarmine Norton Assessment Tool (Timed Arm Curl)
Timed Arm Curl: Number of repetitions an arm curl individuals can complete in 30 seconds)
Measured: 0 and 8-weeks
Bellarmine Norton Assessment Tool (30 second Chair Stand)
Chair Stand: Number of times participants can stand from a sitting position and return to sitting in 30 seconds
Measured: 0 and 8-weeks
Secondary outcomes (1)
Fatigue
The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: The FACIT-Fatigue scale is a 13-item scale that will be used to assess cancer-related fatigue. The FACIT-Fatigue scale is scored on a 0-4 response scale from 0 = "not at all" to 4 "very much", regarding items related to fatigue and energy in the past 7 days. Lower score indicates greater fatigue
Measured: 0 and 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start15 Aug 2021
- Primary completionJan 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciaran Fairman, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039488
- Sponsor's protocol ID
- Pro00109975
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bottone GL, Anderson KS, Brooks AM, Harrington SE, Nakfoor B, Jackson KE, Scott BM, Fairman CM. Evaluating the Test-Retest Reliability and Measurement Error of a Sit-Stand-Power Test in Individuals Treated for Cancer. Integr Cancer Ther. 2026 Jan-Dec;25:15347354261442462. doi: 10.1177/15347354261442462. Epub 2026 Apr 23.
PubMed 42026875Fairman CM, Harrington SE, Schumpp AR, Brooks AM, Jones MJ, Kim J, Kennedy MA. Planning and evaluating an integrated clinical exercise oncology service: an exploratory mixed-methods study. BMC Health Serv Res. 2024 Oct 31;24(1):1318. doi: 10.1186/s12913-024-11797-0.
PubMed 39478564
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of an 8-week Exercise Program on Physical Function in Individuals With Cancer
- ClinicalTrials.gov ID
- NCT06039488
- Acronym / sponsor ID
- Pro00109975
- Conditions
- Cancer
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Sep 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 are examining the impact of an 8-week multi-modal exercise program (resistance and cardiovascular training) delivered 2 times per week on physical function adults (>18 years old) with cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise2 days/week of resistance and cardiovascular exercise for 8-weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults > 18 diagnosed with cancer
Key exclusion criteria (3 listed)
- unwilling to come to the on-site clinic for exercise sessions
- any neuromuscular, cardiovascular, or psychological condition precluding safe exercise
- unable to read/understand English.
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 |
|---|---|---|
| ExerciseA combination of resistance exercise and cardiovascular exercise (performed 2 days per week for 8-weeks) is tailored to each individual in accordance with their medical/cancer-related history, baseline assessments of physical function, and overall goals. Resistance exercise includes 6-8 exercises targeting major muscle groups. The first week of the program is used to familiarize participants to the exercises of the program, provide coaching on safe and appropriate technique, and identifying initial load for 2 sets of 12 repetitions (equivalent to ~65% 1 repetition maximum), with a goal of working towards 4 sets of 8 reps. Additionally, participants are asked to perform 20-30 minutes of moderate-to-vigorous aerobic activity (approximately 60-85% age-predicted heart rate maximum) via walking, jogging, or cycling each session. | Behavioural | Exercise |
Primary outcome
Bellarmine Norton Assessment Tool (2-minute Step Test)
Time frame: 0 and 8-weeks
2-minute Step Test: Number of times an individuals' knee reaches a predetermined heigh during a 2-minute period of marching
Bellarmine Norton Assessment Tool (Timed Arm Curl)
Time frame: 0 and 8-weeks
Timed Arm Curl: Number of repetitions an arm curl individuals can complete in 30 seconds)
Bellarmine Norton Assessment Tool (30 second Chair Stand)
Time frame: 0 and 8-weeks
Chair Stand: Number of times participants can stand from a sitting position and return to sitting in 30 seconds
1 secondary outcome
Fatigue
Time frame: 0 and 8-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Derived from this study: PubMed 42026875Bottone GL, Anderson KS, Brooks AM, Harrington SE, Nakfoor B, Jackson KE, Scott BM, Fairman CM. Evaluating the Test-Retest Reliability and Measurement Error of a Sit-Stand-Power Test in Individuals Treated for Cancer. Integr Cancer Ther. 2026 Jan-Dec;25:15347354261442462. doi: 10.1177/15347354261442462. Epub 2026 Apr 23.
- Derived from this study: PubMed 39478564Fairman CM, Harrington SE, Schumpp AR, Brooks AM, Jones MJ, Kim J, Kennedy MA. Planning and evaluating an integrated clinical exercise oncology service: an exploratory mixed-methods study. BMC Health Serv Res. 2024 Oct 31;24(1):1318. doi: 10.1186/s12913-024-11797-0.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Cancer, run by University of South Carolina 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 1 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 15 Sep 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?
This study is still under way. Results are not available in the source record yet.
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?
Bellarmine Norton Assessment Tool (2-minute Step Test) (time frame: 0 and 8-weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06039488, which also lists 2 linked publications.
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 15 Sep 2023.