STABLE (Strength Training and Balance Leg Exercise) Study

NCT04518098 | Unknown

• 1 other identifier: BIO-1396
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 30-second Chair Stand test

  The 30-second chair stand test will begin with having the participating sitting upright in the middle of the chair with arms folded across the chest with hands placed on the front of the opposite shoulder. The feet are placed flat on the ground at shoulder width and slightly behind the knee. At the initiation of the test using a count down of "ready…go," the participant will stand upright (knees straight and torso fully erect) while maintaining the hand position on the shoulder and then return to a fully seated position in which body weight is shifted from the feet to the chair. The participant will complete as many stand-sit cycles as possible in the 30-second period. The number of sit-to-stands completed within the 30 seconds will be recorded and interpreted based on age group and gender as recommended by the Centers for Disease Control and Prevention STEADI guideline.

  Baseline, 3 & 6 months - to measure change

• Balance test

  Static balance ability will be measured using the Side-by-side Stand (SBS), Semi-tandem Stand (ST), and Full tandem Stand (FT). Participants will be asked to maintain their balance in the three different positions. The amount of time they succeed in maintaining the various positions, in seconds, will be recorded based on the following criteria: Side-by-side 10 sec, semi-tandem 10 sec (1 point); tandem 10 sec (2 points), tandem 3-9.99 second (1 point).

  Baseline, 3 & 6 months - to measure change

• Fall assessment

  Falls will be assessed at t0, t1, and t2 as described, by self-report following recommendations of fall assessment as outlined by the American Geriatrics Society/British Geriatrics Society (AGS/BGS)

  Baseline, 3 & 6 months - to measure change

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Other: Strength and balance exercise

Control group

NO INTERVENTION

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 OTHER

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).

Intervention group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Saskatchewan: lead
• Saskatchewan Health Research Foundation: collaborator

Study Sites (1)

Cross Cancer Institute

Edmonton, Saskatchewan, Canada

RECRUITING

Related Publications (1)

• Sattar S, Haase KR, Alibhai SMH, Penz K, Szafron M, Harenberg S, Amir E, Kuster S, Pitters E, Campbell D, McNeely ML. Feasibility and efficacy of a remotely delivered fall prevention exercise program for community-dwelling older adults with cancer: Protocol for the STABLE trial. J Geriatr Oncol. 2022 Nov;13(8):1273-1280. doi: 10.1016/j.jgo.2022.06.009. Epub 2022 Jul 2.

  PMID: 35792037 DERIVED

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Schroder Sattar, RN, PhD

  College of Nursing

  PRINCIPAL INVESTIGATOR

• Margaret McNeely, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Schroder Sattar, RN, PhD

CONTACT

3063373817; schroder.sattar@usask.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors who collect outcome data will be blinded to group allocation. Participants will be advised to refrain from disclosing their group allocation to the outcome assessor.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: August 19, 2020
• Study Start: January 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: November 30, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)