NCT06039488

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
8mo left

Started Aug 2021

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Aug 2021Jan 2027

Study Start

First participant enrolled

August 15, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

4.4 years

First QC Date

September 5, 2023

Last Update Submit

September 12, 2023

Conditions

Keywords

Exercise

Outcome Measures

Primary Outcomes (3)

  • 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

    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)

    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

    0 and 8-weeks

Secondary Outcomes (1)

  • Fatigue

    0 and 8-weeks

Study Arms (1)

Exercise

EXPERIMENTAL

2 days/week of resistance and cardiovascular exercise for 8-weeks

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

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.

Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults \> 18 diagnosed with cancer

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29205, United States

Location

Related Publications (1)

  • Fairman 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.

MeSH Terms

Conditions

NeoplasmsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 15, 2023

Study Start

August 15, 2021

Primary Completion

January 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations