NCT07059884

Distance-Based Exercise to Preserve Function and Prevent Disability

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength. These side effects can make it difficult to work, take care of family, and do other things the patient wants to do. Preliminary research shows that exercise can help prevent some of these side effects, but it can be more difficult to start an exercise program when a patient is receiving cancer treatment. The exercise program in this study is delivered through telehealth (TH) video calls. The TH sessions are delivered by trained staff that supervise resistance exercises. The trained staff also provide guidance to the patient on completing unsupervised aerobic sessions on their own. This may be a successful way to deliver an exercise program and make it easier for cancer patients to exercise in their own home during treatment.

Detailed description

PRIMARY OBJECTIVES: I. To establish the feasibility of implementing a virtual exercise intervention trial in a diverse cohort of cancer patients undergoing chemotherapy. SECONDARY OBJECTIVE: I. To establish feasibility of enrolling and retaining a diverse patient population. EXPLORATORY OBJECTIVES: I. Evaluate changes in 6 Minute Walk Test (6MWT) distance in the study population between baseline and the post-chemotherapy time point. II. Evaluate changes in grip strength in the study population between baseline and the post-intervention time point. III. Evaluate objective (accelerometer) and self-reported changes (7-Day Physical Activity Recall Interview) in physical activity in the study population between baseline and the post-intervention time point. IV. Explore the relationship between the predicted 6MWT and the baseline 6MWT. V. Explore changes in patient reported outcomes between baseline, end of intervention, and 3-months post intervention in the study population. VI. Explore employment status over time in the study population. OUTLINE: Patients complete supervised TH exercise sessions consisting of progressive resistance exercise twice a week (BIW) and complete unsupervised aerobic exercise sessions over 30 minutes three times per week (TIW) until the end of standard of care (SOC) chemotherapy or up to a total of 6 months, whichever comes first, in the absence of disease progression or unacceptable toxicity. Patients also receive adjustable-weight dumbbells on study and wear an accelerometer throughout the study. After completion of study intervention, patients are followed up at 4 weeks and 3 months.

Conditions

• Hematopoietic and Lymphatic System Neoplasm
• Localized Malignant Solid Neoplasm

Interventions

Type	Name	Description
OTHER	Exercise intervention	Complete supervised TH progressive resistance exercise sessions
OTHER	Telemedicine	Complete supervised TH progressive resistance exercise sessions
OTHER	Aerobic Exercise Intervention	Complete unsupervised aerobic exercise sessions
OTHER	Dumbbell Exercise Intervention	Receive adjustable-weight dumbbells
PROCEDURE	Accelerometry	Wear accelerometer
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Interview	Ancillary studies
OTHER	Electronic Health Record Review	Ancillary studies

Timeline

• Start date: 2026-02-11
• Primary completion: 2027-01-01
• Completion: 2027-02-18
• First posted: 2025-07-11
• Last updated: 2026-04-07

Locations

17 sites across 1 country: United States