Recruiting

Strength Training

Sponsor:

University of Saskatchewan

Code:

NCT04518098

Conditions

Neoplasms

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Strength and balance exercise

Study Details

Brief 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

Study ID

NCT04518098

Start date

Jan 1, 2023

Status verified date

May, 2023

Completion date

Nov 30, 2023

Anticipated

Primary completion date

Sep 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Adults aged 65 or above;
  • living in the community;
  • have a confirmed diagnosis of any stage of lung, breast, prostate, or colorectal cancer; - currently receiving, starting or have completed systemic anti-cancer therapy;
  • life-expectancy of at least 9 months (in consideration of the measurement period of the study and also avoid burdening patients who are near the end-stage of their disease); and - completed the PAR-Q screening or have approval of their treating physician.

Exclusion criteria:

  • presence of brain metastases;
  • presence of unstable metastases as per treating physician (e.g., bone metastasis in a weight-bearing area, recent bone fracture);
  • presence of any conditions that would potentially interfere with their ability to carry out the exercise interventions (e.g., mobility impairment, poorly controlled pain, severe vision/hearing loss, severe arthritis that limits ambulation, left-sided heart failure, neurological or musculoskeletal conditions);
  • self-reported history of light-headedness during physical activities; syncopal episodes within the past month; and
  • participation in any form of structured exercise program (that are at least 30 minutes per week) at the time of consent.

Study Design

Enrollment

74 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention group

Participants in the IG will receive the STABLE intervention, which entails orientation, and undertaking a remotely delivered resistance and balance training regimen 3 times weekly for 3 months

no intervention: Control group

Participants in the CG will not receive the intervention, and will be advised to carry out their usual daily activities.

Interventions

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).

Primary outcome measure

  • 30-second Chair Stand test [ Time Frame: Baseline, 3 & 6 months - to measure change ]
  • Balance test [ Time Frame: Baseline, 3 & 6 months - to measure change ]
  • Fall assessment [ Time Frame: Baseline, 3 & 6 months - to measure change ]

Central Contacts and Locations

Central contacts

Schroder Sattar, RN, PhD

3063373817schroder.sattar@usask.ca

Locations

Cross Cancer Institute

Recruiting

Edmonton, Saskatchewan, Canada

More Information

Sponsor

University of Saskatchewan

Last update posted

May 10, 2023

Last verified

May, 2023

Keywords

  • resistance and balance training
  • fall prevention
  • older adults
  • cancer
  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Saskatchewan on 2023-05-10.