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

ConditionsCancerAging
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorFederal University of Rio Grande do Sul

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Multicomponent TrainingExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Gait 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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

Sociodemographic characteristics

Standardized questionnaire

Time frame
At the enrollment
2

Comorbidities

Standardized questionnaire

Time frame
At the enrollment
3

Stage of the tumor

Standardized questionnaire

Time frame
At the enrollment
4

Type of tumor

Standardized questionnaire

Time frame
At the enrollment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.