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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multicomponent Training | Experimental | Multicomponent exercise |
|
| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multicomponent exercise | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Gait ability | Timed Up and Go test and the 6-meter gait speed test, following the recommendations of Izquierdo (2019) | 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). | 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) | 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. | From enrollment and at 4, 12, 24 and 48 weeks |
| number of hospitalizations | Standardized questionnaire | 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). | From enrollment and at the end of the study, in 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Sociodemographic characteristics | Standardized questionnaire | At the enrollment |
| Comorbidities | Standardized questionnaire | At the enrollment |
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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eduardo L Cadore, PhD | Contact | +555191193651 | edcadore@yahoo.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Eduardo L Cadore, PhD | Federal University of Rio Grande do Sul | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Escola de Educação Física Fisioterapia e Dança - UFRGS | Not yet recruiting | Porto Alegre | Rio Grande do Sul | 90690-200 | Brazil |
Data will be provided only upon request, after the study is completed and published in a scientific journal.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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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.
|
| Mortality rate | Standardized questionnaire | From enrollment and at the end of the study, in 48 weeks |
| Number of falls | Standardized questionnaire | From enrollment and at 4, 12, 24 and 48 weeks |
| 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. | 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. | 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. | 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). | From enrollment and at 4, 12, 24 and 48 weeks |
| Fatigue related symptons | Brief Fatigue Inventory for fatigue assessment (Mendoza et al., 1999) | 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) | From enrollment and at 4, 12, 24 and 48 weeks |
| Disease prognosis | Karnofsky Performance Scale Index for disease prognosis (Schag et al., 1984) | From enrollment and at 4, 12, 24 and 48 weeks |
| Stage of the tumor | Standardized questionnaire | At the enrollment |
| Type of tumor | Standardized questionnaire | At the enrollment |
| Adherence to the exercise program | Exercise adherence will be assessed through monitoring of training logs. | After 4, 12, 24 and 48 weeks of intervention |
| Total body mass | Will be measured using a digital scale | 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. | 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. | 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. | From enrollment and at the end of the study, at 48 weeks |
| Hospital Conceição | Recruiting | Porto Alegre | 91350-200 | Brazil |
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