Trial Outcomes & Findings for Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity (NCT NCT04717050)

NCT ID: NCT04717050

Last Updated: 2026-07-10

Results Overview

Visceral adiposity (VA) measured by waist to hip ratio (WHR)

Recruitment status

COMPLETED

Study phase

Target enrollment

64 participants

Primary outcome timeframe

16 weeks

Results posted on

2026-07-10

Participant Flow

Patient were recruited from Dana-Farber longwood and Merrimack Valley locations and Beth Israel Deaconess Medical Center. Recruitment included screening breast clinic lists and use of patient advertisements in waiting areas, or physician referrals, and working with the Massachusetts Department of Public Health to access data on Latina and/or Hispanic breast cancer patients to send out a mass mail out.

Participant milestones

Participant milestones
Measure	AEROBIC AND RESISTANCE TRAINING SUPERVISED (ACTIVAS) Subjects in the ACTIVAS group will participate in 3 weekly supervised exercise sessions including AE and RE for 4 months (16 weeks). Each exercise session will be supervised by research staff who has been formally trained by the PI on the exercise program to ensure study specificity and adherence to the program.	Attention Control (AC) This group will perform a home-based program of the same stretches utilized in the ACTIVAS group. The stretching protocol consists of one set of 3-4 static stretching exercises held for 30 seconds and performed 3 days/week.
Overall Study STARTED	32	32
Overall Study COMPLETED	26	24
Overall Study NOT COMPLETED	6	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Patients could not complete testing due to scheduling, time constraints, etc.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 16 weeks

Population: Said measure is reported while more direct measure of viseral adiposity is analyzed from DEXA.

Visceral adiposity (VA) measured by waist to hip ratio (WHR)

Outcome measures

Outcome measures
Measure	AEROBIC AND RESISTANCE TRAINING SUPERVISED (ACTIVAS) n=30 Participants Subjects in the ACTIVAS group will participate in 3 weekly supervised exercise sessions including AE and RE for 4 months (16 weeks). Each exercise session will be supervised by research staff who has been formally trained by the PI on the exercise program to ensure study specificity and adherence to the program.	Attention Control (AC) n=31 Participants This group will perform a home-based program of the same stretches utilized in the ACTIVAS group. The stretching protocol consists of one set of 3-4 static stretching exercises held for 30 seconds and performed 3 days/week.
Metabolic Dysregulation (MetD) - Visceral Adiposity	0.82 ratio Standard Deviation 0.06	0.84 ratio Standard Deviation 0.06

OTHER_PRE_SPECIFIED outcome

Timeframe: 16 weeks

Cardiopulmonary fitness as measured by stress test and metabolic cart

Outcome measures

Outcome data not reported

Adverse Events

AEROBIC AND RESISTANCE TRAINING SUPERVISED (ACTIVAS)

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Attention Control (AC)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AEROBIC AND RESISTANCE TRAINING SUPERVISED (ACTIVAS) n=32 participants at risk Subjects in the ACTIVAS group will participate in 3 weekly supervised exercise sessions including AE and RE for 4 months (16 weeks). Each exercise session will be supervised by research staff who has been formally trained by the PI on the exercise program to ensure study specificity and adherence to the program.	Attention Control (AC) n=32 participants at risk This group will perform a home-based program of the same stretches utilized in the ACTIVAS group. The stretching protocol consists of one set of 3-4 static stretching exercises held for 30 seconds and performed 3 days/week.
Cardiac disorders Pulmonary Hypertension	3.1% 1/32 • Number of events 1 • From enrollment until end of follow-up, up to 33 weeks	0.00% 0/32 • From enrollment until end of follow-up, up to 33 weeks
Psychiatric disorders Depression	3.1% 1/32 • Number of events 1 • From enrollment until end of follow-up, up to 33 weeks	0.00% 0/32 • From enrollment until end of follow-up, up to 33 weeks

Other adverse events

Other adverse events
Measure	AEROBIC AND RESISTANCE TRAINING SUPERVISED (ACTIVAS) n=32 participants at risk Subjects in the ACTIVAS group will participate in 3 weekly supervised exercise sessions including AE and RE for 4 months (16 weeks). Each exercise session will be supervised by research staff who has been formally trained by the PI on the exercise program to ensure study specificity and adherence to the program.	Attention Control (AC) n=32 participants at risk This group will perform a home-based program of the same stretches utilized in the ACTIVAS group. The stretching protocol consists of one set of 3-4 static stretching exercises held for 30 seconds and performed 3 days/week.
Nervous system disorders Headache	3.1% 1/32 • Number of events 1 • From enrollment until end of follow-up, up to 33 weeks	0.00% 0/32 • From enrollment until end of follow-up, up to 33 weeks
Nervous system disorders Vertigo and Nausea	0.00% 0/32 • From enrollment until end of follow-up, up to 33 weeks	3.1% 1/32 • Number of events 1 • From enrollment until end of follow-up, up to 33 weeks
Gastrointestinal disorders Nausea	0.00% 0/32 • From enrollment until end of follow-up, up to 33 weeks	3.1% 1/32 • Number of events 1 • From enrollment until end of follow-up, up to 33 weeks
Immune system disorders Allergic reaction	0.00% 0/32 • From enrollment until end of follow-up, up to 33 weeks	3.1% 1/32 • Number of events 1 • From enrollment until end of follow-up, up to 33 weeks
Musculoskeletal and connective tissue disorders Foot, Arm, Ankle Pain	0.00% 0/32 • From enrollment until end of follow-up, up to 33 weeks	3.1% 1/32 • Number of events 1 • From enrollment until end of follow-up, up to 33 weeks
Musculoskeletal and connective tissue disorders Ankle sprain	3.1% 1/32 • Number of events 1 • From enrollment until end of follow-up, up to 33 weeks	0.00% 0/32 • From enrollment until end of follow-up, up to 33 weeks

Additional Information

Christina Dieli-Conwright

Dana-Farber Cancer Institute

Phone: 617-582-8321

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	AEROBIC AND RESISTANCE TRAINING SUPERVISED (ACTIVAS) n=32 Participants Subjects in the ACTIVAS group will participate in 3 weekly supervised exercise sessions including AE and RE for 4 months (16 weeks). Each exercise session will be supervised by research staff who has been formally trained by the PI on the exercise program to ensure study specificity and adherence to the program.	Attention Control (AC) n=32 Participants This group will perform a home-based program of the same stretches utilized in the ACTIVAS group. The stretching protocol consists of one set of 3-4 static stretching exercises held for 30 seconds and performed 3 days/week.	Total n=64 Participants Total of all reporting groups
Hand Grip Strength	23.59 kg STANDARD_DEVIATION 5.49 • n=29 Participants • Patients could not complete testing due to scheduling, time constraints, etc.	24.76 kg STANDARD_DEVIATION 5.17 • n=30 Participants • Patients could not complete testing due to scheduling, time constraints, etc.	24.18 kg STANDARD_DEVIATION 5.32 • n=59 Participants • Patients could not complete testing due to scheduling, time constraints, etc.
Age, Categorical <=18 years	0 Participants n=32 Participants	0 Participants n=32 Participants	0 Participants n=64 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=32 Participants	29 Participants n=32 Participants	54 Participants n=64 Participants
Age, Categorical >=65 years	7 Participants n=32 Participants	3 Participants n=32 Participants	10 Participants n=64 Participants
Sex/Gender, Customized Female	32 Participants n=32 Participants	32 Participants n=32 Participants	64 Participants n=64 Participants
Race/Ethnicity, Customized Latina/Hispanic	32 Participants n=32 Participants	32 Participants n=32 Participants	64 Participants n=64 Participants
Region of Enrollment United States	32 participants n=32 Participants	32 participants n=32 Participants	64 participants n=64 Participants
Blood Pressure SYS - Baseline	116.66 mmHg STANDARD_DEVIATION 11.10 • n=32 Participants	118.27 mmHg STANDARD_DEVIATION 14.26 • n=32 Participants	117.46 mmHg STANDARD_DEVIATION 12.70 • n=64 Participants
Blood Pressure DIA - Baseline	77.1 mmHg STANDARD_DEVIATION 5.3 • n=32 Participants	78.5 mmHg STANDARD_DEVIATION 8.3 • n=32 Participants	77.82 mmHg STANDARD_DEVIATION 6.94 • n=64 Participants
Visceral Adiposity	816.94 g STANDARD_DEVIATION 297.41 • n=32 Participants • Patients could not complete testing due to scheduling, time constraints, etc.	807.52 g STANDARD_DEVIATION 277.45 • n=29 Participants • Patients could not complete testing due to scheduling, time constraints, etc.	812.46 g STANDARD_DEVIATION 285.74 • n=61 Participants • Patients could not complete testing due to scheduling, time constraints, etc.
Cardiopulmonary Fitness - Absolute VO2	1.21 ml/kg/min STANDARD_DEVIATION 0.31 • n=27 Participants • Patients could not complete testing due to scheduling, time constraints, etc.	1.30 ml/kg/min STANDARD_DEVIATION 0.37 • n=31 Participants • Patients could not complete testing due to scheduling, time constraints, etc.	1.26 ml/kg/min STANDARD_DEVIATION 0.34 • n=58 Participants • Patients could not complete testing due to scheduling, time constraints, etc.
Muscle strength Leg Press Est. 1RM	67.68 kg STANDARD_DEVIATION 25.90 • n=29 Participants • Patients could not complete testing due to scheduling, time constraints, etc.	68.19 kg STANDARD_DEVIATION 22.90 • n=31 Participants • Patients could not complete testing due to scheduling, time constraints, etc.	67.94 kg STANDARD_DEVIATION 24.18 • n=60 Participants • Patients could not complete testing due to scheduling, time constraints, etc.
Muscle strength Chest Press Est. 1RM	22.55 kg STANDARD_DEVIATION 6.71 • n=30 Participants • Patients could not complete testing due to scheduling, time constraints, etc.	23.37 kg STANDARD_DEVIATION 8.47 • n=32 Participants • Patients could not complete testing due to scheduling, time constraints, etc.	22.98 kg STANDARD_DEVIATION 7.62 • n=62 Participants • Patients could not complete testing due to scheduling, time constraints, etc.
Weight	77.1 kg STANDARD_DEVIATION 15.0 • n=32 Participants • Patients could not complete testing due to scheduling, time constraints, etc.	78.9 kg STANDARD_DEVIATION 13.3 • n=32 Participants • Patients could not complete testing due to scheduling, time constraints, etc.	78.0 kg STANDARD_DEVIATION 14.1 • n=64 Participants • Patients could not complete testing due to scheduling, time constraints, etc.
BMI	30.4 kg/m^2 STANDARD_DEVIATION 6.2 • n=32 Participants • Patients could not complete testing due to scheduling, time constraints, etc.	30.9 kg/m^2 STANDARD_DEVIATION 5.0 • n=32 Participants • Patients could not complete testing due to scheduling, time constraints, etc.	30.7 kg/m^2 STANDARD_DEVIATION 5.6 • n=64 Participants • Patients could not complete testing due to scheduling, time constraints, etc.
Waist Circumference	94.4 cm STANDARD_DEVIATION 11.0 • n=30 Participants • Patients could not complete testing due to scheduling, time constraints, etc.	95.7 cm STANDARD_DEVIATION 11.2 • n=31 Participants • Patients could not complete testing due to scheduling, time constraints, etc.	95.1 cm STANDARD_DEVIATION 11.0 • n=61 Participants • Patients could not complete testing due to scheduling, time constraints, etc.
Hip Circumference	114.75 cm STANDARD_DEVIATION 13.46 • n=30 Participants • Patients could not complete testing due to scheduling, time constraints, etc.	113.86 cm STANDARD_DEVIATION 10.98 • n=31 Participants • Patients could not complete testing due to scheduling, time constraints, etc.	114.3 cm STANDARD_DEVIATION 12.17 • n=61 Participants • Patients could not complete testing due to scheduling, time constraints, etc.
Waist to Hip Ratio	0.82 ratio STANDARD_DEVIATION 0.06 • n=30 Participants • Patients could not complete testing due to scheduling, time constraints, etc.	0.84 ratio STANDARD_DEVIATION 0.06 • n=31 Participants • Patients could not complete testing due to scheduling, time constraints, etc.	0.83 ratio STANDARD_DEVIATION 0.06 • n=61 Participants • Patients could not complete testing due to scheduling, time constraints, etc.
Height	159.4 cm STANDARD_DEVIATION 5.4 • n=32 Participants	159.9 cm STANDARD_DEVIATION 5.9 • n=32 Participants	159.6 cm STANDARD_DEVIATION 5.7 • n=64 Participants