An interventional study of Multicomponent exercise in Cancer and Aging, sponsored by Federal University of Rio Grande do Sul. Recruiting at 2 sites in Brazil. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Federal University of Rio Grande do Sul · Not applicable, Interventional, and Treatment
This study aims to understand how a home-based exercise program can help improve strength, mobility, and quality of life in older adults receiving cancer treatment.
Participants will be randomly divided into two groups:
One group will follow a one-year multicomponent exercise program based on the ViviFrail model, done safely at home.
The other group will continue with usual care.
We will include men and women aged 60 or older treated at Hospital Conceição in Porto Alegre. Assessments will take place at the beginning and after 12, 24, and 48 weeks.
We will measure walking speed, balance, muscle strength, and ask about quality of life, symptoms, and daily activity.
The goal is to see whether home-based exercise can help older adults with cancer stay stronger, more independent, and feel better during treatment.
The main objective of this study is to identify and compare the effects of a one-year physical exercise program based on the ViviFrail model versus usual care on functional capacity, neuromuscular parameters, quality of life, and disease-related symptoms in older adults undergoing cancer treatment.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 180 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Federal University of Rio Grande do Sul is the lead sponsor of 121 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Men and women aged 60 years or older who are undergoing cancer treatment at Hospital Conceição in Porto Alegre, who have the cognitive ability to understand the exercises, are able to walk (even with assistance), and have medical clearance to participate in physical exercise will be included in the study.
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Exclusion Criteria: Participants who miss more than two assessments will be excluded.
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Multicomponent exercise
Behavioral: Multicomponent exercise
Patients randomized to the control group will receive general health guidance and instructions to continue with their usual care. To monitor participants in both groups over time, monthly contacts will be made via phone or messaging app.
Participants randomized to the intervention group will receive educational material about exercising during cancer treatment. In addition, they will receive a physical exercise passport based on the ViviFrail program (A, B, C, or D) according to their baseline assessment. The passport includes instructions and illustrations of each exercise, as well as details on the number of sets and repetitions, required equipment, and a training log. Furthermore, participants in the intervention group will have access to online materials, including videos demonstrating each exercise, and will attend a pre-scheduled in-person session at Hospital Conceição in Porto Alegre to address any questions.
Gait ability
Timed Up and Go test and the 6-meter gait speed test, following the recommendations of Izquierdo (2019)
Time frame: From enrollment and at 4, 12, 24 and 48 weeks
Hand grip strength
Will be measured using a Jamar Hydraulic Hand Dynamometer, following the guidelines of the American Society of Hand Therapists (MacDermid et al., 2015).
Time frame: From enrollment and at 4, 12, 24 and 48 weeks
SPPB Battery
SPPB tests: the five-times sit-to-stand test from a standard chair, 4-meter gait speed test, and balance tests in bipodal, semi-tandem, and tandem positions. (Izquierdo, 2019)
Time frame: From enrollment and at 4, 12, 24 and 48 weeks
Peak power on seat to standing movement
using a linear displacement transducer (encoder) during the three-times sit-to-stand test from a standard chair. The participant will start seated, with their hands resting on their knees, and the encoder will be attached to the right wrist using a Velcro strap. At the command "go," the participant will be instructed to stand up from the chair as quickly as possible and sit back down, repeating the movement three times.
Time frame: From enrollment and at 4, 12, 24 and 48 weeks
number of hospitalizations
Standardized questionnaire
Time frame: From enrollment and at the end of the study, in 48 weeks
Treatment toxicity
NCI-PRO-CTCAE ITEMS - Portuguese for Brazil, following the recommendations of Pires et al. (2022).
Time frame: From enrollment and at the end of the study, in 48 weeks
Mortality rate
Standardized questionnaire
Time frame: From enrollment and at the end of the study, in 48 weeks
Number of falls
Standardized questionnaire
Time frame: From enrollment and at 4, 12, 24 and 48 weeks
Physical activity level
Physical activity level will be assessed using the Baecke Physical Activity Questionnaire (Simões, 2009), which refers to the 12 months prior to the study and is divided into questions related to daily living activities, sports activities, and leisure activities. Participants will be classified as low physical activity (≤ 9.11 points), moderately active (9.12 to 16.17 points), or highly active (≥ 16.18 points).
Time frame: From enrollment and at the end of the study, in 48 weeks
Vastus lateralis muscle thickness
Muscle thickness will be assessed using ultrasonography (Nemio XG, Toshiba, Japan) of the vastus lateralis of the participants' right leg, following the recommendations of Pinto et al. (2015). Three images of the vastus lateralis will be collected at 30% of the distance from the lateral femoral epicondyle to the greater trochanter, along the patella. A tracing map on acetate will be produced to ensure greater precision in repeated measurements.
Time frame: From enrollment and at 4, 12, 24 and 48 weeks
Vastus intermedius muscle thickness
Muscle thickness will be assessed using ultrasonography (Nemio XG, Toshiba, Japan) of the vastus intermedius of the participants' right leg, following the recommendations of Pinto et al. (2015). Three images of the vastus intermedius will be collected at 50% of the distance from the lateral femoral epicondyle to the greater trochanter, along the midline of the patella. A tracing map on acetate will be produced to ensure greater precision in repeated measurements.
Time frame: From enrollment and at 4, 12, 24 and 48 weeks
Rectus femoralis muscle thickness
Muscle thickness will be assessed using ultrasonography (Nemio XG, Toshiba, Japan) of the rectus femoralis of the participants' right leg, following the recommendations of Pinto et al. (2015). Three images of the vastus intermedius will be collected at 50% of the distance from the lateral femoral epicondyle to the greater trochanter, along the midline of the patella. A tracing map on acetate will be produced to ensure greater precision in repeated measurements.
Time frame: From enrollment and at 4, 12, 24 and 48 weeks
Quality of Life Questionnarie
Will be assessed using the Nottingham Health Profile (NHP), which contains 38 items related to overall quality of life and produces a score ranging from 0 (best quality of life) to 38 (worst quality of life) (Teixeira-Salmela et al., 2004).
Time frame: From enrollment and at 4, 12, 24 and 48 weeks
Fatigue related symptons
Brief Fatigue Inventory for fatigue assessment (Mendoza et al., 1999)
Time frame: From enrollment and at 4, 12, 24 and 48 weeks
Sleep quality
Pittsburgh Sleep Quality Index - BR for sleep quality assessment (Buysse et al., 1989)
Time frame: From enrollment and at 4, 12, 24 and 48 weeks
Disease prognosis
Karnofsky Performance Scale Index for disease prognosis (Schag et al., 1984)
Time frame: From enrollment and at 4, 12, 24 and 48 weeks
Sociodemographic characteristics
Standardized questionnaire
Time frame: At the enrollment
Comorbidities
Standardized questionnaire
Time frame: At the enrollment
Stage of the tumor
Standardized questionnaire
Time frame: At the enrollment
Type of tumor
Standardized questionnaire
Time frame: At the enrollment
Adherence to the exercise program
Exercise adherence will be assessed through monitoring of training logs.
Time frame: After 4, 12, 24 and 48 weeks of intervention
Total body mass
Will be measured using a digital scale
Time frame: From enrollment and at the end of the study, in 48 weeks
Body height
Will be measured using a measuring tape with 1 mm resolution.
Time frame: From enrollment and at the end of the study, at 48 weeks
Waist circunference
Will be measured using a measuring tape with 1 mm resolution.
Time frame: From enrollment and at the end of the study, at 48 weeks
Nutritional assessment
Nutritional status will be evaluated using a three-day dietary recall.
Time frame: From enrollment and at the end of the study, at 48 weeks
Plan to share: No — Data will be provided only upon request, after the study is completed and published in a scientific journal.
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Mar 2027, 11 months after the start.
Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 11 months is below that.
Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
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Federal University of Rio Grande do Sul →