Feasibility of Home vs. Hospital Based Resistance Training for Advanced Cancer Patients

NCT02930876 | Completed Phase 2

• 1 other identifier: HR-15/16-2960
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer causes 8.2 million deaths each year, with an estimated worldwide cost of $895 billion. Pharmacological treatments provide improvements in expected survival and symptoms, but at cost of a high rate of toxicities and increased time spent by patients away from their homes and families during treatment. This is particularly important for patients with advanced disease as the timeframe at stake relates to their last months of life. Sarcopenia (i.e. loss of muscle mass together with decreased functional capacity) has been widely reported as an important prognostic factor in advanced cancer, with impact on survival, toxicities, response to treatment and other patient-centered outcomes (such as functional capacity, quality of life and fatigue). Sarcopenia is a term first used in 1988 by Rosenberg, meaning an age-related loss in skeletal muscle mass and function. It was derived from the greek: sarx = flesh and penia = loss. In 2010, a European Consensus defined sarcopenia as a triad of muscle mass loss, decreased functional performance and muscle strength. It has been reported as a hallmark of cancer, with impact on prognosis, response to treatments, side effects of chemotherapy and recovery after surgery. The prevalence of sarcopenia in advanced cancer seems to vary according to gender, stage, primary tumor location and treatments, being present in about 28 to 67% of patients. Exercise, in particular resistance training, is one of the most powerful ways of increasing muscle mass and evidence from elderly patients suggests that it is among the most promising interventions for sarcopenia. There is evidence that resistance training can be effective but evidence is still scarce for patients with advanced disease. Historically there have been some concerns regarding safety and efficacy for oncologic patients, and though evidence suggests that resistance training is one of the most preferred forms of exercise by patients, the effectiveness of resistance training alone on sarcopenia in patients with advanced cancer remains unknown. Another question is whether home (which seems to be the patients' preferred location for exercise) produces better results than hospital (the traditional location).

Conditions

Advanced Cancer

Keywords

sarcopenia; cancer; chemotherapy; palliative care; resistance training

Outcome Measures

Primary Outcomes (2)

• Number of training sessions completed

  Feasibility of the two intervention models assessed by the number of sessions completed

  3 months after baseline (at the end of the training program)

• Number of exercises done within each session

  Feasibility of the two intervention models assessed by the number of exercises completed in each session

  3 months after baseline (at the end of the training program)

Secondary Outcomes (9)

• Tolerability

  3 months after baseline (at the end of the training program)

• Safety of the exercise program

  3 months after baseline (at the end of the training program)

• Change in muscle mass after the 3 months of exercise

  Reported at baseline and 3 months after enrolment;

• Frequency of treatment related toxicities

  Reported at baseline and 3 months after enrolment;

• Change in strength after the 3 months of exercise

  Reported at baseline and 3 months after enrolment;

Study Arms (3)

Resistance training at home

EXPERIMENTAL

Participants will undergo training sessions at their own homes. The exercise program will be individualized and guided by trained physiotherapists, for 3 months completion, aiming at 2-3 sessions a week (27 to 40 sessions in total), each lasting 45-60 minutes.

Behavioral: Resistance training

Resistance training at the hospital

EXPERIMENTAL

Participants will undergo training sessions at the hospital. The exercise program will be individualized and guided by trained physiotherapists, for 3 months completion, aiming at 2-3 sessions a week (27 to 40 sessions in total), each lasting 45-60 minutes.

Behavioral: Resistance training

Controls

NO INTERVENTION

Participants will be given an information leaflet with the exercise recommendations of the Portuguese national ministry of health.

Interventions

Resistance training BEHAVIORAL

Set of muscle strengthening exercises of all major muscle groups, guided by physiotherapists.

Resistance training at home; Resistance training at the hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- histological diagnosis of cancer, incurable (stage IIIB/IV according to AJCC 2010).

You may not qualify if:

• chemotherapy within 90 days prior to study enrollment
• not having a baseline (pre-treatment) Computed Tomography of the Thorax Abdomen and Pelvis (CTTAP) and whole body dual x-ray absorptometry (DXA) (this is important because having an assessment of baseline muscle mass will allow us to control for baseline sarcopenia and calculate changes from baseline to post-intervention)
• bone metastasis in risk of fracture
• inability to comply with the intervention for any known reasons (including physical or mental impairment that limits the capacity to undertake the exercise program)
• considered to be at cardiovascular risk (defined by a pre-exercise cardiologic evaluation with electrocardiogram (ECG) and echocardiogram when indicated (echocardiogram if \>50 years old, NYHA class I, angor, cardiovascular risk factors and abnormal ECG)).

Sponsors & Collaborators

• King's College London: lead
• Calouste Gulbenkian Foundation: collaborator
• Centro Hospitalar Lisboa Central: collaborator

Study Sites (1)

King's College of London

London, London, SE5 9PJ, United Kingdom

Location

Related Publications (1)

• Ribeiro C, Santos R, Correia P, Maddocks M, Gomes B. Resistance training in advanced cancer: a phase II safety and feasibility trial-home versus hospital. BMJ Support Palliat Care. 2022 Sep;12(3):287-291. doi: 10.1136/bmjspcare-2020-002230. Epub 2020 Aug 13.

  PMID: 32792420 DERIVED

MeSH Terms

Conditions

Sarcopenia; Neoplasms

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: October 12, 2016
• Study Start: July 1, 2016
• Primary Completion: February 8, 2017
• Study Completion: February 8, 2017
• Last Updated: March 7, 2017

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)