Trial Outcomes & Findings for Trial Comparing the Effects of Linear Versus Nonlinear Aerobic Training in Women With Operable Breast Cancer (NCT NCT01186367)
NCT ID: NCT01186367
Last Updated: 2025-02-10
Results Overview
VO2 or peak oxygen consumption will be measured at Baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
174 participants
Primary outcome timeframe
Baseline
Results posted on
2025-02-10
Participant Flow
Participant milestones
| Measure |
Linear Aerobic Training
The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training, at 60% to 75 % of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at baseline.
Linear Aerobic Training: The 130-180 minutes/week will be achieved via either 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes per/session (± 10 minutes).
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count
|
Nonlinear Aerobic Training
The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at Baseline and as well as the CPET performed at Midpoint.
Nonlinear Aerobic Training: The 130-180 minutes/week will be achieved via 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes/ per session (+/- 10 minutes).
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count
|
Progressive Stretching Group (Attention Control)
The ultimate goal for the progressive stretching program is 3 to 4 individual stretching sessions/week for 10 to 50 minutes per session (+/- 10 minutes).
Progressive Stretching: All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count
|
|---|---|---|---|
|
Overall Study
STARTED
|
58
|
59
|
57
|
|
Overall Study
COMPLETED
|
51
|
54
|
50
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
7
|
Reasons for withdrawal
| Measure |
Linear Aerobic Training
The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training, at 60% to 75 % of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at baseline.
Linear Aerobic Training: The 130-180 minutes/week will be achieved via either 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes per/session (± 10 minutes).
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count
|
Nonlinear Aerobic Training
The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at Baseline and as well as the CPET performed at Midpoint.
Nonlinear Aerobic Training: The 130-180 minutes/week will be achieved via 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes/ per session (+/- 10 minutes).
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count
|
Progressive Stretching Group (Attention Control)
The ultimate goal for the progressive stretching program is 3 to 4 individual stretching sessions/week for 10 to 50 minutes per session (+/- 10 minutes).
Progressive Stretching: All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
4
|
7
|
|
Overall Study
Did not receive study treatment
|
0
|
1
|
0
|
Baseline Characteristics
Trial Comparing the Effects of Linear Versus Nonlinear Aerobic Training in Women With Operable Breast Cancer
Baseline characteristics by cohort
| Measure |
Linear Aerobic Training
n=58 Participants
The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training, at 60% to 75 % of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at baseline.
Linear Aerobic Training: The 130-180 minutes/week will be achieved via either 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes per/session (± 10 minutes).
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count
|
Nonlinear Aerobic Training
n=59 Participants
The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at Baseline and as well as the CPET performed at Midpoint.
Nonlinear Aerobic Training: The 130-180 minutes/week will be achieved via 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes/ per session (+/- 10 minutes).
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count
|
Progressive Stretching Group (Attention Control)
n=57 Participants
The ultimate goal for the progressive stretching program is 3 to 4 individual stretching sessions/week for 10 to 50 minutes per session (+/- 10 minutes).
Progressive Stretching: All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count
|
Total
n=174 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
58 years
n=7 Participants
|
58 years
n=5 Participants
|
58 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
174 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
149 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
58 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
174 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: BaselineVO2 or peak oxygen consumption will be measured at Baseline
Outcome measures
| Measure |
Linear Aerobic Training
n=58 Participants
The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training, at 60% to 75 % of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at baseline.
Linear Aerobic Training: The 130-180 minutes/week will be achieved via either 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes per/session (± 10 minutes).
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count
|
Nonlinear Aerobic Training
n=59 Participants
The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at Baseline and as well as the CPET performed at Midpoint.
Nonlinear Aerobic Training: The 130-180 minutes/week will be achieved via 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes/ per session (+/- 10 minutes).
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count
|
Progressive Stretching Group (Attention Control)
n=57 Participants
The ultimate goal for the progressive stretching program is 3 to 4 individual stretching sessions/week for 10 to 50 minutes per session (+/- 10 minutes).
Progressive Stretching: All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count
|
|---|---|---|---|
|
To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.
|
21.5 mL/kg/min
Standard Deviation 4.4
|
22.2 mL/kg/min
Standard Deviation 4.3
|
21.8 mL/kg/min
Standard Deviation 3.8
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Only nonlinear aerobic training measured at 8 weeks
VO2 or peak oxygen consumption for nonlinear aerobic training will be measured at mid-point (8 weeks)
Outcome measures
| Measure |
Linear Aerobic Training
The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training, at 60% to 75 % of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at baseline.
Linear Aerobic Training: The 130-180 minutes/week will be achieved via either 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes per/session (± 10 minutes).
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count
|
Nonlinear Aerobic Training
n=58 Participants
The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at Baseline and as well as the CPET performed at Midpoint.
Nonlinear Aerobic Training: The 130-180 minutes/week will be achieved via 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes/ per session (+/- 10 minutes).
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count
|
Progressive Stretching Group (Attention Control)
The ultimate goal for the progressive stretching program is 3 to 4 individual stretching sessions/week for 10 to 50 minutes per session (+/- 10 minutes).
Progressive Stretching: All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count
|
|---|---|---|---|
|
To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.
|
—
|
22.6 mL/kg/min
Standard Deviation 4.5
|
—
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Nonlinear aerobic training measured at 16 weeks
VO2 or peak oxygen consumption will be measured at post-intervention (16 weeks).
Outcome measures
| Measure |
Linear Aerobic Training
n=58 Participants
The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training, at 60% to 75 % of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at baseline.
Linear Aerobic Training: The 130-180 minutes/week will be achieved via either 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes per/session (± 10 minutes).
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count
|
Nonlinear Aerobic Training
n=59 Participants
The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at Baseline and as well as the CPET performed at Midpoint.
Nonlinear Aerobic Training: The 130-180 minutes/week will be achieved via 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes/ per session (+/- 10 minutes).
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count
|
Progressive Stretching Group (Attention Control)
n=57 Participants
The ultimate goal for the progressive stretching program is 3 to 4 individual stretching sessions/week for 10 to 50 minutes per session (+/- 10 minutes).
Progressive Stretching: All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count
|
|---|---|---|---|
|
To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.
|
22.2 mL/kg/min
Standard Deviation 4.6
|
23.1 mL/kg/min
Standard Deviation 4.8
|
21.8 mL/kg/min
Standard Deviation 3.7
|
Adverse Events
Linear Aerobic Training
Serious events: 0 serious events
Other events: 58 other events
Deaths: 0 deaths
Nonlinear Aerobic Training
Serious events: 0 serious events
Other events: 59 other events
Deaths: 0 deaths
Progressive Stretching Group (Attention Control)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Linear Aerobic Training
n=58 participants at risk
The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training, at 60% to 75 % of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at baseline.
Linear Aerobic Training: The 130-180 minutes/week will be achieved via either 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes per/session (± 10 minutes).
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count
|
Nonlinear Aerobic Training
n=59 participants at risk
The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at Baseline and as well as the CPET performed at Midpoint.
Nonlinear Aerobic Training: The 130-180 minutes/week will be achieved via 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes/ per session (+/- 10 minutes).
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count
|
Progressive Stretching Group (Attention Control)
n=57 participants at risk
The ultimate goal for the progressive stretching program is 3 to 4 individual stretching sessions/week for 10 to 50 minutes per session (+/- 10 minutes).
Progressive Stretching: All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count
|
|---|---|---|---|
|
Cardiac disorders
Abnormal heart response
|
8.6%
5/58 • 16 weeks
|
3.4%
2/59 • 16 weeks
|
0.00%
0/57 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.4%
13/58 • 16 weeks
|
25.4%
15/59 • 16 weeks
|
1.8%
1/57 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
6/58 • 16 weeks
|
10.2%
6/59 • 16 weeks
|
3.5%
2/57 • 16 weeks
|
|
Nervous system disorders
Dizziness
|
10.3%
6/58 • 16 weeks
|
11.9%
7/59 • 16 weeks
|
0.00%
0/57 • 16 weeks
|
|
General disorders
General fatigue
|
12.1%
7/58 • 16 weeks
|
11.9%
7/59 • 16 weeks
|
1.8%
1/57 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Lower extremity fatigue
|
3.4%
2/58 • 16 weeks
|
6.8%
4/59 • 16 weeks
|
0.00%
0/57 • 16 weeks
|
|
Metabolism and nutrition disorders
Pain in extremity
|
24.1%
14/58 • 16 weeks
|
16.9%
10/59 • 16 weeks
|
3.5%
2/57 • 16 weeks
|
|
Vascular disorders
Abnormal blood pressure response
|
1.7%
1/58 • 16 weeks
|
1.7%
1/59 • 16 weeks
|
1.8%
1/57 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Low oxygen saturation
|
3.4%
2/58 • 16 weeks
|
1.7%
1/59 • 16 weeks
|
0.00%
0/57 • 16 weeks
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.4%
2/58 • 16 weeks
|
0.00%
0/59 • 16 weeks
|
0.00%
0/57 • 16 weeks
|
|
General disorders
Other
|
13.8%
8/58 • 16 weeks
|
18.6%
11/59 • 16 weeks
|
1.8%
1/57 • 16 weeks
|
Additional Information
Dr. Jessica Scott, PhD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-8093
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place