Cancer, Aging
Conditions
Keywords
Aging, Neoplasia, Physical activity
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMulticomponent exercise
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.
Sponsors
Federal University of Rio Grande do Sul
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The person responsible for the randomization will not be one of the researchers involved in the assessments and will have no contact with the participants. Questionnaires and tests will be administered by evaluators blinded to the participants' group allocation.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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. \-
Exclusion criteria
Participants who miss more than two assessments will be excluded. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait ability | From enrollment and at 4, 12, 24 and 48 weeks | Timed Up and Go test and the 6-meter gait speed test, following the recommendations of Izquierdo (2019) |
| Hand grip strength | From enrollment and at 4, 12, 24 and 48 weeks | Will be measured using a Jamar Hydraulic Hand Dynamometer, following the guidelines of the American Society of Hand Therapists (MacDermid et al., 2015). |
| SPPB Battery | From enrollment and at 4, 12, 24 and 48 weeks | 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) |
| Peak power on seat to standing movement | From enrollment and at 4, 12, 24 and 48 weeks | 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. |
| number of hospitalizations | From enrollment and at the end of the study, in 48 weeks | Standardized questionnaire |
| Treatment toxicity | From enrollment and at the end of the study, in 48 weeks | NCI-PRO-CTCAE ITEMS - Portuguese for Brazil, following the recommendations of Pires et al. (2022). |
| Mortality rate | From enrollment and at the end of the study, in 48 weeks | Standardized questionnaire |
| Number of falls | From enrollment and at 4, 12, 24 and 48 weeks | Standardized questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity level | From enrollment and at the end of the study, in 48 weeks | 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). |
| Vastus lateralis muscle thickness | From enrollment and at 4, 12, 24 and 48 weeks | 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. |
| Vastus intermedius muscle thickness | From enrollment and at 4, 12, 24 and 48 weeks | 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. |
| Rectus femoralis muscle thickness | From enrollment and at 4, 12, 24 and 48 weeks | 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. |
| Quality of Life Questionnarie | From enrollment and at 4, 12, 24 and 48 weeks | 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). |
| Fatigue related symptons | From enrollment and at 4, 12, 24 and 48 weeks | Brief Fatigue Inventory for fatigue assessment (Mendoza et al., 1999) |
| Sleep quality | From enrollment and at 4, 12, 24 and 48 weeks | Pittsburgh Sleep Quality Index - BR for sleep quality assessment (Buysse et al., 1989) |
| Disease prognosis | From enrollment and at 4, 12, 24 and 48 weeks | Karnofsky Performance Scale Index for disease prognosis (Schag et al., 1984) |
Countries
Brazil
Contacts
CONTACTEduardo L Cadore, PhD
PRINCIPAL_INVESTIGATOREduardo L Cadore, PhD
Federal University of Rio Grande do Sul
Outcome results
None listed