CancerNCT07565519
Effects of a Multicomponent Exercise Program in Older Adults Undergoing Cancer Treatment: A Randomized Controlled Trial
A study testing Multicomponent exercise in people with Cancer and Aging, run by Federal University of Rio Grande do Sul at 2 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- What is being tested?
- Multicomponent exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesBrazil
- Study dates
- 2 Mar 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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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Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Not yet recruiting
Escola de Educação Física Fisioterapia e Dança - UFRGS
Porto Alegre, Rio Grande do Sul, 90690-200
Eduardo L Cadore, PhD, +555191193651, edcadore@yahoo.com.br
- Recruiting
Hospital Conceição
Porto Alegre, 91350-200
Eduarda Blanco Rambo, Me, 5551999079773, eduardarambo@gmail.com
About this study
Official title: Effects of a Multicomponent Exercise Program on Functional Capacity, Neuromuscular Parameters, Quality of Life, and Disease-Related Symptoms in Older Adults Undergoing Cancer Treatment: A Randomized, Controlled Clinical Trial
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:
Read more
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.
Read the 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.
- Being tested
- Multicomponent exercise
- Keywords
- Aging, Neoplasia, Physical activity
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent Training | Experimental | Multicomponent exercise Receives: Behavioral: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait ability
Timed Up and Go test and the 6-meter gait speed test, following the recommendations of Izquierdo (2019)
Measured: 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).
Measured: 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)
Measured: 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.
Measured: From enrollment and at 4, 12, 24 and 48 weeks
number of hospitalizations
Standardized questionnaire
Measured: 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).
Measured: From enrollment and at the end of the study, in 48 weeks
Mortality rate
Standardized questionnaire
Measured: From enrollment and at the end of the study, in 48 weeks
Number of falls
Standardized questionnaire
Measured: From enrollment and at 4, 12, 24 and 48 weeks
Secondary outcomes (8)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: From enrollment and at 4, 12, 24 and 48 weeks
Fatigue related symptons
Brief Fatigue Inventory for fatigue assessment (Mendoza et al., 1999)
Measured: 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)
Measured: From enrollment and at 4, 12, 24 and 48 weeks
Disease prognosis
Karnofsky Performance Scale Index for disease prognosis (Schag et al., 1984)
Measured: From enrollment and at 4, 12, 24 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start2 Mar 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Lusa Cadore, Federal University of Rio Grande do Sul
- Investigators
- Eduardo L Cadore, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565519
- Sponsor's protocol ID
- URioGrandeCancer
- Status last verified
- Oct 2025
- First submitted
- 27 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be provided only upon request, after the study is completed and published in a scientific journal.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multicomponent Exercise Program on Functional Capacity, Neuromuscular Parameters, Quality of Life, and Disease-Related Symptoms in Older Adults Undergoing Cancer Treatment: A Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07565519
- Acronym / sponsor ID
- URioGrandeCancer
- Keywords
- Aging, Neoplasia, Physical activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Training | Experimental | Behavioral: Multicomponent exerciseMulticomponent 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent exerciseParticipants 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. | Behavioural | Multicomponent Training |
Primary outcome
Gait ability
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From enrollment and at the end of the study, in 48 weeks
Standardized questionnaire
Treatment toxicity
Time frame: 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
Time frame: From enrollment and at the end of the study, in 48 weeks
Standardized questionnaire
Number of falls
Time frame: From enrollment and at 4, 12, 24 and 48 weeks
Standardized questionnaire
8 secondary outcomes
Physical activity level
Time frame: From enrollment and at the end of the study, in 48 weeks
Vastus lateralis muscle thickness
Time frame: From enrollment and at 4, 12, 24 and 48 weeks
Vastus intermedius muscle thickness
Time frame: From enrollment and at 4, 12, 24 and 48 weeks
Rectus femoralis muscle thickness
Time frame: From enrollment and at 4, 12, 24 and 48 weeks
Quality of Life Questionnarie
Time frame: From enrollment and at 4, 12, 24 and 48 weeks
Fatigue related symptons
Time frame: From enrollment and at 4, 12, 24 and 48 weeks
Sleep quality
Time frame: From enrollment and at 4, 12, 24 and 48 weeks
Disease prognosis
Time frame: From enrollment and at 4, 12, 24 and 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No. Data will be provided only upon request, after the study is completed and published in a scientific journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eduardo L Cadore, PhD principal investigator
Federal University of Rio Grande do Sul
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent exercise in people with Cancer and Aging, run by Federal University of Rio Grande do Sul at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eduardo L Cadore, PhD (+555191193651, edcadore@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait ability (time frame: From enrollment and at 4, 12, 24 and 48 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.