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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
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.
Escola de Educação Física Fisioterapia e Dança - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
NOT_YET_RECRUITINGHospital Conceição
Porto Alegre, Brazil
RECRUITINGGait 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
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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