Trial Outcomes & Findings for Exercise Program in Cancer and Cognition (NCT NCT02793921)

Last Updated: 2024-02-28

Results Overview

Cognitive function was assessed with a battery of 14 measures. A data reduction technique, exploratory factor analysis with principal component extraction and varimax (orthogonal) rotation, was used to create summary factors. The cognitive factors identified included processing speed, attention, mental flexibility, working memory, learning and memory, verbal memory, and executive function were derived via this factor analysis. Individual measures with the highest loadings were included in each factor. All measures had factor loadings \>0.400. Scores from the individual measures for each factor were normed based on healthy controls of similar age and education to yield a z-score and these were summed to yield an average z-score for each factor. Z-scores range from -4 to +4, where higher z-scores indicate better performance for each factor.

Recruitment status

COMPLETED

Study phase

Target enrollment

153 participants

Primary outcome timeframe

Baseline to 6 months

Results posted on

2024-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	Moderate-intensity Aerobic Exercise Participants engage in a supervised 6-month moderate-intensity aerobic exercise intervention. Moderate-Intensity Aerobic Exercise Intervention: The intervention is moderate-intensity aerobic exercise. Walking on a motorized treadmill will be the encouraged mode of exercise; however participants may use other equipment or home exercise. Participants will begin by exercising 10-15 minutes for 3 days/week during the first 2 weeks and gradually increase the duration for the following 4 weeks until they reach 40-50 minutes per session/3 days per week. This level is then maintained for the remainder of the 6 months. The rate of increase will be tailored based on baseline cardiorespiratory fitness and response to exercise. All sessions start and end with a vital sign check (in-person) and 5-10 minutes warm-up/cool-down. Trained exercise physiologists will supervise all exercise sessions and closely monitor adherence, intensity, and safety when sessions are completed in-person, or through regular communication when home-based exercise is warranted (due to COVID-19).	Usual Care Physical activity neither limited nor withheld. Participants engage in activity in the same manner as if they were not part of an active intervention.
Overall Study STARTED	77	76
Overall Study COMPLETED	77	76
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exercise Program in Cancer and Cognition

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Moderate-intensity Aerobic Exercise n=77 Participants Participants engage in a supervised 6-month moderate-intensity aerobic exercise intervention. Moderate-Intensity Aerobic Exercise Intervention: The intervention is moderate-intensity aerobic exercise. Walking on a motorized treadmill will be the encouraged mode of exercise; however participants may use other equipment or home exercise. Participants will begin by exercising 10-15 minutes for 3 days/week during the first 2 weeks and gradually increase the duration for the following 4 weeks until they reach 40-50 minutes per session/3 days per week. This level is then maintained for the remainder of the 6 months. The rate of increase will be tailored based on baseline cardiorespiratory fitness and response to exercise. All sessions start and end with a vital sign check (in-person) and 5-10 minutes warm-up/cool-down. Trained exercise physiologists will supervise all exercise sessions and closely monitor adherence, intensity, and safety when sessions are completed in-person, or through regular communication when home-based exercise is warranted (due to COVID-19).	Usual Care n=76 Participants Physical activity neither limited nor withheld. Participants engage in activity in the same manner as if they were not part of an active intervention.	Total n=153 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants	43 Participants n=7 Participants	88 Participants n=5 Participants
Age, Categorical >=65 years	32 Participants n=5 Participants	33 Participants n=7 Participants	65 Participants n=5 Participants
Age, Continuous	61.44 years STANDARD_DEVIATION 8.96 • n=5 Participants	62.75 years STANDARD_DEVIATION 7.25 • n=7 Participants	62.09 years STANDARD_DEVIATION 8.27 • n=5 Participants
Sex: Female, Male Female	77 Participants n=5 Participants	76 Participants n=7 Participants	153 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 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
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	68 Participants n=5 Participants	69 Participants n=7 Participants	137 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	77 participants n=5 Participants	76 participants n=7 Participants	153 participants n=5 Participants
BMI, Customized	30.46 kg/m^2 STANDARD_DEVIATION 7.21 • n=5 Participants	31.14 kg/m^2 STANDARD_DEVIATION 6.01 • n=7 Participants	30.8 kg/m^2 STANDARD_DEVIATION 6.7 • n=5 Participants
Disease Stage: DCIS, I, IIa, IIb, IIIa DCIS	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants
Disease Stage: DCIS, I, IIa, IIb, IIIa Stage 1	44 Participants n=5 Participants	54 Participants n=7 Participants	98 Participants n=5 Participants
Disease Stage: DCIS, I, IIa, IIb, IIIa Stage 2a	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Disease Stage: DCIS, I, IIa, IIb, IIIa Stage 2b	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Disease Stage: DCIS, I, IIa, IIb, IIIa Stage 3a	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6 months

Outcome measures

Outcome measures
Measure	Moderate-intensity Aerobic Exercise n=77 Participants Participants engage in a supervised 6-month moderate-intensity aerobic exercise intervention. Moderate-Intensity Aerobic Exercise Intervention: The intervention is moderate-intensity aerobic exercise. Walking on a motorized treadmill will be the encouraged mode of exercise; however participants may use other equipment or home exercise. Participants will begin by exercising 10-15 minutes for 3 days/week during the first 2 weeks and gradually increase the duration for the following 4 weeks until they reach 40-50 minutes per session/3 days per week. This level is then maintained for the remainder of the 6 months. The rate of increase will be tailored based on baseline cardiorespiratory fitness and response to exercise. All sessions start and end with a vital sign check (in-person) and 5-10 minutes warm-up/cool-down. Trained exercise physiologists will supervise all exercise sessions and closely monitor adherence, intensity, and safety when sessions are completed in-person, or through regular communication when home-based exercise is warranted (due to COVID-19).	Usual Care n=76 Participants Physical activity neither limited nor withheld. Participants engage in activity in the same manner as if they were not part of an active intervention.
Change in Cognitive Function Processing Speed	-0.05 z-score Standard Error 0.02	0.01 z-score Standard Error 0.02
Change in Cognitive Function Attention	0.21 z-score Standard Error 0.04	0.17 z-score Standard Error 0.04
Change in Cognitive Function Mental Flexibility	-0.05 z-score Standard Error 0.03	-0.07 z-score Standard Error 0.03
Change in Cognitive Function Working Memory	0.28 z-score Standard Error 0.11	0.13 z-score Standard Error 0.12
Change in Cognitive Function Learning and Memory	0.13 z-score Standard Error 0.06	0.05 z-score Standard Error 0.06
Change in Cognitive Function Verbal Memory	-0.17 z-score Standard Error 0.09	-0.18 z-score Standard Error 0.09
Change in Cognitive Function Executive Function	-0.02 z-score Standard Error 0.03	-0.02 z-score Standard Error 0.02

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The sample size for the total brain size analysis is smaller than the total number of participants because, imaging was planned on a subset of the overall sample, the impact of COVID precluded imaging for a time, the MRI machine was switched during the study, so it would have required some participants to use one imaging machine and another set with a second machine. Thus, the parameters of the sequences and the image quality would have been different between machines, and budget cuts.

High-resolution anatomical MPRAGE (1mm3 voxels, 256 slices) images will be used for volumetric analyses. The FreeSurfer pipeline using its longitudinal option will be employed to compute cortical volumes.

Outcome measures

Outcome measures
Measure	Moderate-intensity Aerobic Exercise n=17 Participants Participants engage in a supervised 6-month moderate-intensity aerobic exercise intervention. Moderate-Intensity Aerobic Exercise Intervention: The intervention is moderate-intensity aerobic exercise. Walking on a motorized treadmill will be the encouraged mode of exercise; however participants may use other equipment or home exercise. Participants will begin by exercising 10-15 minutes for 3 days/week during the first 2 weeks and gradually increase the duration for the following 4 weeks until they reach 40-50 minutes per session/3 days per week. This level is then maintained for the remainder of the 6 months. The rate of increase will be tailored based on baseline cardiorespiratory fitness and response to exercise. All sessions start and end with a vital sign check (in-person) and 5-10 minutes warm-up/cool-down. Trained exercise physiologists will supervise all exercise sessions and closely monitor adherence, intensity, and safety when sessions are completed in-person, or through regular communication when home-based exercise is warranted (due to COVID-19).	Usual Care n=16 Participants Physical activity neither limited nor withheld. Participants engage in activity in the same manner as if they were not part of an active intervention.
Total Brain Size Baseline	1026742.118 mm-cubed Standard Deviation 75232.467	1044057.647 mm-cubed Standard Deviation 102747.151
Total Brain Size 6 Months	1033171.625 mm-cubed Standard Deviation 69084.048	1058477.167 mm-cubed Standard Deviation 103402.622

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: The number of participants analyzed for the pro-inflammatory cytokines, IL-5 and TNF-alpha is smaller than what is reported in the participant flow module because the impact of COVID precluded securing the blood samples for IL-6 and TNF-alpha for a time.

Cytokine levels for interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) were determined using high-sensitivity, quantitative sandwich enzyme immunoassay run according to manufacturer's directions. Greater pgs/ML indicate higher levels of both IL-6 and TNF-aplha.

Outcome measures

Outcome measures
Measure	Moderate-intensity Aerobic Exercise n=58 Participants Participants engage in a supervised 6-month moderate-intensity aerobic exercise intervention. Moderate-Intensity Aerobic Exercise Intervention: The intervention is moderate-intensity aerobic exercise. Walking on a motorized treadmill will be the encouraged mode of exercise; however participants may use other equipment or home exercise. Participants will begin by exercising 10-15 minutes for 3 days/week during the first 2 weeks and gradually increase the duration for the following 4 weeks until they reach 40-50 minutes per session/3 days per week. This level is then maintained for the remainder of the 6 months. The rate of increase will be tailored based on baseline cardiorespiratory fitness and response to exercise. All sessions start and end with a vital sign check (in-person) and 5-10 minutes warm-up/cool-down. Trained exercise physiologists will supervise all exercise sessions and closely monitor adherence, intensity, and safety when sessions are completed in-person, or through regular communication when home-based exercise is warranted (due to COVID-19).	Usual Care n=55 Participants Physical activity neither limited nor withheld. Participants engage in activity in the same manner as if they were not part of an active intervention.
Pro-inflammatory Cytokines TNF-a	0.07 pg/ML Standard Error 0.01	0.09 pg/ML Standard Error 0.01
Pro-inflammatory Cytokines IL-6	0.47 pg/ML Standard Error 0.07	0.45 pg/ML Standard Error 0.07

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The number of participants analyzed for peak VO2 is smaller than what is reported in the participant flow module because the impact of COVID precluded securing VO2 for a time.

Fitness will be measured by submaximal VO2 test. The submaximal test is similar to the full test, but stops at 85% of the age-predicted heart rate. The protocol involves walking at a self-selected pace between 2.0-4.0 mph with increasing grade increments of 2% every two minutes. The test is terminated when the subject reaches 85% of their age-predicted heart rate or at volitional exhaustion. Higher levels (ml/kg/minute) indicate better peak VO2.

Outcome measures

Outcome measures
Measure	Moderate-intensity Aerobic Exercise n=62 Participants Participants engage in a supervised 6-month moderate-intensity aerobic exercise intervention. Moderate-Intensity Aerobic Exercise Intervention: The intervention is moderate-intensity aerobic exercise. Walking on a motorized treadmill will be the encouraged mode of exercise; however participants may use other equipment or home exercise. Participants will begin by exercising 10-15 minutes for 3 days/week during the first 2 weeks and gradually increase the duration for the following 4 weeks until they reach 40-50 minutes per session/3 days per week. This level is then maintained for the remainder of the 6 months. The rate of increase will be tailored based on baseline cardiorespiratory fitness and response to exercise. All sessions start and end with a vital sign check (in-person) and 5-10 minutes warm-up/cool-down. Trained exercise physiologists will supervise all exercise sessions and closely monitor adherence, intensity, and safety when sessions are completed in-person, or through regular communication when home-based exercise is warranted (due to COVID-19).	Usual Care n=66 Participants Physical activity neither limited nor withheld. Participants engage in activity in the same manner as if they were not part of an active intervention.
Peak VO2 Baseline	17.31 ml/kg/minute Standard Error 0.42	17.72 ml/kg/minute Standard Error 0.48
Peak VO2 6 months	18.44 ml/kg/minute Standard Error 0.38	19.74 ml/kg/minute Standard Error 3.88

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: The number of participants analyzed for estradiol is smaller than what is reported in the participant flow module because the impact of COVID precluded securing blood samples for estradiol for a time.

E2 was determined by a competitive binding immunoassay, according to manufacturer's directions. Greater pgs/ML indicate higher levels of estradiol.

Outcome measures

Outcome measures
Measure	Moderate-intensity Aerobic Exercise n=58 Participants Participants engage in a supervised 6-month moderate-intensity aerobic exercise intervention. Moderate-Intensity Aerobic Exercise Intervention: The intervention is moderate-intensity aerobic exercise. Walking on a motorized treadmill will be the encouraged mode of exercise; however participants may use other equipment or home exercise. Participants will begin by exercising 10-15 minutes for 3 days/week during the first 2 weeks and gradually increase the duration for the following 4 weeks until they reach 40-50 minutes per session/3 days per week. This level is then maintained for the remainder of the 6 months. The rate of increase will be tailored based on baseline cardiorespiratory fitness and response to exercise. All sessions start and end with a vital sign check (in-person) and 5-10 minutes warm-up/cool-down. Trained exercise physiologists will supervise all exercise sessions and closely monitor adherence, intensity, and safety when sessions are completed in-person, or through regular communication when home-based exercise is warranted (due to COVID-19).	Usual Care n=55 Participants Physical activity neither limited nor withheld. Participants engage in activity in the same manner as if they were not part of an active intervention.
Estradiol (E2) Levels	0.48 pg/ML Standard Error 0.07	0.67 pg/ML Standard Error 0.12

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The sample size for the analysis of the fatigue data is smaller than the total numbers in the Participant Flow module because the impact of COVID precluded securing fatigue measurement for a time.

The Fatigue 8a Patient Reported Outcomes Measurement Information System (PROMIS) short form was used to measure fatigue. It consists of 8 items on which participants respond using a 5-point Likert scale. The scores range from 0 to 24 with higher scores indicating greater fatigue.

Outcome measures

Outcome measures
Measure	Moderate-intensity Aerobic Exercise n=76 Participants Participants engage in a supervised 6-month moderate-intensity aerobic exercise intervention. Moderate-Intensity Aerobic Exercise Intervention: The intervention is moderate-intensity aerobic exercise. Walking on a motorized treadmill will be the encouraged mode of exercise; however participants may use other equipment or home exercise. Participants will begin by exercising 10-15 minutes for 3 days/week during the first 2 weeks and gradually increase the duration for the following 4 weeks until they reach 40-50 minutes per session/3 days per week. This level is then maintained for the remainder of the 6 months. The rate of increase will be tailored based on baseline cardiorespiratory fitness and response to exercise. All sessions start and end with a vital sign check (in-person) and 5-10 minutes warm-up/cool-down. Trained exercise physiologists will supervise all exercise sessions and closely monitor adherence, intensity, and safety when sessions are completed in-person, or through regular communication when home-based exercise is warranted (due to COVID-19).	Usual Care n=66 Participants Physical activity neither limited nor withheld. Participants engage in activity in the same manner as if they were not part of an active intervention.
Fatigue Baseline	18.60 score on a scale Standard Deviation 0.82	18.90 score on a scale Standard Deviation 0.86
Fatigue 6 months	17.81 score on a scale Standard Deviation 0.92	16.83 score on a scale Standard Deviation 0.97

SECONDARY outcome

Timeframe: Baseline to 6 months

The eight-item Anxiety 8a PROMIS short form was used to measure anxiety. Participants rate each item on a scale from 1 to 5. The score is the total of the responses with higher scores indicating greater anxiety. The range of scores is 5 to 40.

Outcome measures

Outcome measures
Measure	Moderate-intensity Aerobic Exercise n=77 Participants Participants engage in a supervised 6-month moderate-intensity aerobic exercise intervention. Moderate-Intensity Aerobic Exercise Intervention: The intervention is moderate-intensity aerobic exercise. Walking on a motorized treadmill will be the encouraged mode of exercise; however participants may use other equipment or home exercise. Participants will begin by exercising 10-15 minutes for 3 days/week during the first 2 weeks and gradually increase the duration for the following 4 weeks until they reach 40-50 minutes per session/3 days per week. This level is then maintained for the remainder of the 6 months. The rate of increase will be tailored based on baseline cardiorespiratory fitness and response to exercise. All sessions start and end with a vital sign check (in-person) and 5-10 minutes warm-up/cool-down. Trained exercise physiologists will supervise all exercise sessions and closely monitor adherence, intensity, and safety when sessions are completed in-person, or through regular communication when home-based exercise is warranted (due to COVID-19).	Usual Care n=76 Participants Physical activity neither limited nor withheld. Participants engage in activity in the same manner as if they were not part of an active intervention.
Anxiety	1.85 units on a scale Standard Error 0.36	1.55 units on a scale Standard Error 0.28

SECONDARY outcome

Timeframe: Baseline to 6 months

Sleep problems were measured using global score of the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-report measure that consists of 19 items. Each item is weighted on a 0-3 interval scale. The PSQI global score ranges from 0 to 21, where lower scores indicate better sleep quality, and higher scores indicate poorer sleep quality.

Outcome measures

Outcome measures
Measure	Moderate-intensity Aerobic Exercise n=77 Participants Participants engage in a supervised 6-month moderate-intensity aerobic exercise intervention. Moderate-Intensity Aerobic Exercise Intervention: The intervention is moderate-intensity aerobic exercise. Walking on a motorized treadmill will be the encouraged mode of exercise; however participants may use other equipment or home exercise. Participants will begin by exercising 10-15 minutes for 3 days/week during the first 2 weeks and gradually increase the duration for the following 4 weeks until they reach 40-50 minutes per session/3 days per week. This level is then maintained for the remainder of the 6 months. The rate of increase will be tailored based on baseline cardiorespiratory fitness and response to exercise. All sessions start and end with a vital sign check (in-person) and 5-10 minutes warm-up/cool-down. Trained exercise physiologists will supervise all exercise sessions and closely monitor adherence, intensity, and safety when sessions are completed in-person, or through regular communication when home-based exercise is warranted (due to COVID-19).	Usual Care n=76 Participants Physical activity neither limited nor withheld. Participants engage in activity in the same manner as if they were not part of an active intervention.
Sleep Problems	12.21 units on a scale Standard Error 1.57	13.36 units on a scale Standard Error 1.62

SECONDARY outcome

Timeframe: Baseline to 6 months

Depressive symptoms will be measured using the Beck Depression Inventory II (BDI II). The 21-item BDI II is a self-report measure on which participants rate depressive symptoms on a four-point scale. The BDI II score ranges from 0 to 63 with higher scores indicating greater depressive symptomatology.

Outcome measures

Outcome measures
Measure	Moderate-intensity Aerobic Exercise n=77 Participants Participants engage in a supervised 6-month moderate-intensity aerobic exercise intervention. Moderate-Intensity Aerobic Exercise Intervention: The intervention is moderate-intensity aerobic exercise. Walking on a motorized treadmill will be the encouraged mode of exercise; however participants may use other equipment or home exercise. Participants will begin by exercising 10-15 minutes for 3 days/week during the first 2 weeks and gradually increase the duration for the following 4 weeks until they reach 40-50 minutes per session/3 days per week. This level is then maintained for the remainder of the 6 months. The rate of increase will be tailored based on baseline cardiorespiratory fitness and response to exercise. All sessions start and end with a vital sign check (in-person) and 5-10 minutes warm-up/cool-down. Trained exercise physiologists will supervise all exercise sessions and closely monitor adherence, intensity, and safety when sessions are completed in-person, or through regular communication when home-based exercise is warranted (due to COVID-19).	Usual Care n=76 Participants Physical activity neither limited nor withheld. Participants engage in activity in the same manner as if they were not part of an active intervention.
Depressive Symptoms	5.51 units on a scale Standard Error 0.71	5.27 units on a scale Standard Error 0.61

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6 months

Outcome measures

Outcome data not reported

Adverse Events

Moderate-intensity Aerobic Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Catherine Bender, Principal Investigator

University of Pittsburgh

Phone: 412-624-3594

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place