MedTrace Logo

STABLE (Strength Training and Balance Leg Exercise) Study

NCT04518098 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2023-05-10

No results posted yet for this study

Summary

Falls are a major health concern amongst older adults with cancer, and are often related to decreased physical strength due to effects of cancer and its treatments. Ample evidence demonstrates the benefits of exercise programs incorporating strength and balance training on lower body strength, balance, and fall prevention older adults. However, gaps in research exist within the geriatric oncology context. The purpose of this study is to determine the feasibility and efficacy of a 3-month, remotely delivered exercise program regimen on lower body strength, balance, and falls in older adults with cancer.

This observer-blinded, randomized controlled feasibility trial aims to recruit older cancer patients (aged ≥65). Participants in the intervention group will undertake the exercise program 3 times weekly for three months. Data collection will include sociodemographic survey, baseline, end-of-intervention (3-month) assessment, follow-up (6-month) assessment, chart review, and exit survey. Descriptive and inferential statistics will be used to analyze data, following the intention-to-treatment principle.

Data generated from this research project will inform design of a subsequent, larger exercise intervention trial. This is an important step to establish the knowledge base regarding provision of exercise interventions as a fall prevention strategy to reduce falls and their negative outcomes in older patients in the community.

Conditions

  • Neoplasms

Interventions

OTHER

Strength and balance exercise

The exercise program consists of muscle strengthening and balance training exercises that progress in difficulty. After completion of the baseline assessment and randomization, IG participants will receive orientation and learn the exercise routines (in the Cancer Rehabilitation Clinic within the Faculty of Rehabilitation Medicine at the University of Alberta). The duration of training is 3 months (40-50 minutes per scheduled session, three times a week) at home, with a minimum of one live group session supervised by the CEP, a minimum of one independent home session supported by the Active Living module of the HEAL-ME application; (the third session can be a live session or independent session at the participant's discretion).

Sponsors & Collaborators

  • Saskatchewan Health Research Foundation

    collaborator OTHER

  • University of Saskatchewan

    lead OTHER

Principal Investigators

  • Schroder Sattar, RN, PhD · College of Nursing

  • Margaret McNeely, PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-09-30
Completion
2023-11-30

Countries

  • Canada

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04518098 on ClinicalTrials.gov