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NCT Number: NCT07565519

Effects of a Multicomponent Exercise Program in Older Adults Undergoing Cancer Treatment: A Randomized Controlled 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:

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Escola de Educação Física Fisioterapia e Dança - UFRGS, Porto Alegre, Rio Grande do Sul, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

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.

Primary outcomes

  1. 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)

  2. 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).

  3. 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)

  4. 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.

  5. number of hospitalizations

    Time frame: From enrollment and at the end of the study, in 48 weeks

    Standardized questionnaire

  6. 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).

  7. Mortality rate

    Time frame: From enrollment and at the end of the study, in 48 weeks

    Standardized questionnaire

  8. Number of falls

    Time frame: From enrollment and at 4, 12, 24 and 48 weeks

    Standardized questionnaire

Secondary outcomes

  1. Physical activity level

    Time frame: 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).

  2. Vastus lateralis muscle thickness

    Time frame: 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.

  3. Vastus intermedius muscle thickness

    Time frame: 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.

  4. Rectus femoralis muscle thickness

    Time frame: 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.

  5. Quality of Life Questionnarie

    Time frame: 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).

  6. Fatigue related symptons

    Time frame: From enrollment and at 4, 12, 24 and 48 weeks

    Brief Fatigue Inventory for fatigue assessment (Mendoza et al., 1999)

  7. Sleep quality

    Time frame: From enrollment and at 4, 12, 24 and 48 weeks

    Pittsburgh Sleep Quality Index - BR for sleep quality assessment (Buysse et al., 1989)

  8. Disease prognosis

    Time frame: From enrollment and at 4, 12, 24 and 48 weeks

    Karnofsky Performance Scale Index for disease prognosis (Schag et al., 1984)

Other outcomes

  1. Sociodemographic characteristics

    Time frame: At the enrollment

    Standardized questionnaire

  2. Comorbidities

    Time frame: At the enrollment

    Standardized questionnaire

  3. Stage of the tumor

    Time frame: At the enrollment

    Standardized questionnaire

  4. Type of tumor

    Time frame: At the enrollment

    Standardized questionnaire

  5. Adherence to the exercise program

    Time frame: After 4, 12, 24 and 48 weeks of intervention

    Exercise adherence will be assessed through monitoring of training logs.

  6. Total body mass

    Time frame: From enrollment and at the end of the study, in 48 weeks

    Will be measured using a digital scale

  7. Body height

    Time frame: From enrollment and at the end of the study, at 48 weeks

    Will be measured using a measuring tape with 1 mm resolution.

  8. Waist circunference

    Time frame: From enrollment and at the end of the study, at 48 weeks

    Will be measured using a measuring tape with 1 mm resolution.

  9. Nutritional assessment

    Time frame: From enrollment and at the end of the study, at 48 weeks

    Nutritional status will be evaluated using a three-day dietary recall.

Study contacts

Contact information is provided by the study sponsor or research team.

Eduardo L Cadore, PhD

CONTACT

[email protected]

+555191193651

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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