Heart rate variability-based prediction of early cardiotoxicity in breast-cancer patients treated with anthracyclines and trastuzumab.
Santiago Luna-Alcala, Adrián Espejel-Guzmán, Claudia Lerma...
https://pubmed.ncbi.nlm.nih.gov/38812020/Actively Recruiting
Led by Universidad Complutense de Madrid · Updated on 2026-10-01
26
Participants Needed
1
Research Sites
8 weeks
Total Duration
Researchers are evaluating the impact of adding a controlled breathing exercise program to a therapeutic exercise intervention on heart and lung function in people with multiple myeloma who are receiving active treatment with daratumumab. This randomized, double-blind clinical trial aims to understand how these combined exercises affect key cardiorespiratory variables over a 6-week period. Participants are divided into two groups. Both groups receive a therapeutic exercise program that includes three weekly sessions of mobility and muscle-strengthening exercises, with two supervised on-site sessions and one home-based session per week. They also attend an educational session on proper breathing and are encouraged to walk at least 7,000 steps or 50 minutes three times weekly. The experimental group additionally performs a home-based controlled breathing exercise twice daily and attends two brief in-person breathing training sessions at the hospital to ensure proper technique. Participants will be assessed before and after the 6-week intervention and again 4 weeks later. Measurements include heart rate variability indicators, heart rate, lower limb strength through the 30-Second Sit-to-Stand Test, and estimated peak oxygen consumption. Heart rate and variability are also tracked immediately before and after breathing training sessions and a reinforcement session post-intervention. Adherence is monitored through a smartphone app, and the study lasts approximately 10 weeks including follow-up.
CONDITIONS
Effects of Controlled Breathing on Cardiorespiratory Variables in Multiple Myeloma
I
Isidro Fernández-López, PhD
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Universidad Complutense de Madrid
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility evaluation
Duration - 6 weeks
Participants perform therapeutic exercises three times weekly with two supervised sessions and one home session, along with walking goals. The experimental group also practices controlled breathing exercises twice daily and attends two brief in-person breathing training sessions.
Two in-person breathing training sessions and regular supervised exercise visits
Duration - 4 weeks
Participants are evaluated 4 weeks after completing the intervention to assess lasting effects on heart and lung function.
1 follow-up visit
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/28546966/Universidad Complutense de Madrid
Lead Sponsor