ISRCTN ISRCTN25624573
DOI https://doi.org/10.1186/ISRCTN25624573
Secondary identifying numbers 16168
Submission date
26/06/2023
Registration date
27/06/2023
Last edited
23/08/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Resistance training is an important way for older adults to maintain their muscle mass and strength, which can help them avoid mobility limitations, sarcopenia (age-related progressive loss of muscle mass and strength), and frailty as they age. However, many older adults don't participate in resistance training because traditional programs can be difficult or expensive. Resistance bands are lightweight and easy to use, and recent studies have shown they can be effective in improving muscle strength and physical function in older adults. We propose using resistance bands in a new resistance training program that can be done both in person and online.

Who can participate?
We are recruiting community-dwelling older women and men aged 70 years and older.

What does the study involve?
This study involves participating in a resistance training program using bands twice a week for 18 weeks led by registered kinesiologists or completing simple flexibility exercises.

What are the possible benefits and risks of participating?
Participants are expected to benefit by accruing new or maintaining current muscle, strength and improving or preserving physical function.
As with any research, there are risks of participating such as during blood sampling or the physical function measures. The researcher team has done everything possible to mitigate any risks and will gladly provide further information if requested.

Where is the study run from?
McMaster University (Canada)

When is the study starting and how long is it expected to run for?
January 2023 to September 2024

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Stuart Phillips, phillis@mcmaster.ca

Contact information

Prof Stuart Phillips
Principal Investigator

1280 Main Street West
Department of Kinesiology
McMaster University
Hamilton
L8S 4K1
Canada

ORCiD logoORCID ID 0000-0002-1956-4098
Phone +1 (905) 525-9140 ext. 24465
Email phillis@mcmaster.ca
Ms Giulia Coletta
Public

1280 Main Street West
Department of Kinesiology
McMaster University
Hamilton
L8S 4K1
Canada

ORCiD logoORCID ID 0000-0002-0834-986X
Phone +1 (905)-525-9140 Ext. 21918
Email giuliacoletta@mcmaster.ca
Prof Stuart Phillips
Scientific

1280 Main Street West
Department of Kinesiology
McMaster University
Hamilton
L8S 4K1
Canada

Phone +1 (905) 525-9140 ext. 24465
Email phillis@mcmaster.ca

Study information

Study designSingle-centre interventional randomized control trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Fitness/sport facility, University/medical school/dental school
Study typePrevention, Treatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleThe impact of a resistance band training program on older adults' physical function
Study objectives1. 18 weeks of resistance training using resistance bands will improve functional capacity compared to a control group.
2. 18 weeks of resistance training using resistance bands will improve muscle strength, muscle mass, mobility, sarcopenia, habitual physical activity, frailty, and health-related quality of life compared to a control group.
Ethics approval(s)

Approved 12/06/2023, Hamilton Integrated Research Ethics Board (293 Wellington St. N., Suite 120, Hamilton, L8L 8E7, Canada; +1 905-521-2100 Ext. 42013; eREBhelpdesk@hhsc.ca), ref: 16168

Health condition(s) or problem(s) studiedPrevention of mobility limitation and sarcopenia
InterventionParticipants will be randomized to either the resistance training group (intervention) or the flexibility group (control) using an online service known as sealed envelope https://www.sealedenvelope.com.

Participants in the resistance training group will sequentially complete the three phases of this study using a faded contact approach:
1. IN-PERSON phase (6 weeks) – twice-weekly group-based resistance training classes led by registered kinesiologists (R. Kins) and physiotherapists.
2. IN-PERSON & ONLINE (6 weeks) – twice-weekly (one class in-person and one class on Zoom) group-based resistance training classes led by R. Kins and physiotherapists.
3. ONLINE (6 weeks)– twice-weekly, online, group-based resistance training classes led by R. Kins and physiotherapists.

Measurements will be taken at baseline and the end of each phase.

The control group will receive the Canadian Society for Exercise Physiology 24-hour movement guidelines and simple flexibility exercises.
Intervention typeBehavioural
Primary outcome measureFunctional capacity measured using various physical function measures such as the short physical performance battery, timed up and go, 6-minute walk test at baseline and the end of each phase.
Secondary outcome measures1. Strength measured using handgrip and the stair climb power test at baseline and the end of each phase.
2. Proxies of muscle mass measured using Deuterium-labelled creatine (D3-Cr) and dual-energy X-ray absorptiometry (DEXA) at baseline and the end of each phase.
3. Sarcopenia measured using physical function, strength, and muscle mass and the Strength (S), Assistance walking (A), Rising from a chair (R), Climbing stairs (C), and Falls (F) (SARC-F) questionnaire at baseline and end of study.
4. Mobility measured using the Manty preclinical mobility limitation and life-space mobility assessments. at baseline and end of study.
5. Health-related quality of life measured using the SF-36 at baseline and end of study.
6. Physical activity levels measured using accelerometry and the PASE questionnaire.
7. Frailty measured using the Fit-Frailty Index at baseline and end of study.
8. General health measured using bloods and blood pressure at baseline and end of study.
Overall study start date04/01/2023
Completion date30/09/2024

Eligibility

Participant type(s)Healthy volunteer
Age groupSenior
Lower age limit70 Years
SexBoth
Target number of participants60
Key inclusion criteria1. Community-dwelling older adults 70 years of age and older
2. Are preclinically mobility limited based on self-report according to Manty’s preclinical mobility limitation questionnaire
3. Able to walk independently and without assistive devices
4. Are eligible to participate in regular physical activity according to the Canadian Society Exercise Physiology Get Active Questionnaire
5. Have a body mass index (BMI) between 18.5 - 35 kg/m² (inclusive)
6. Willing and able to provide informed consent (speaks and understands English)
7. Generally healthy
Key exclusion criteria1. Have a history of neuromuscular conditions or muscle-wasting diseases
2. Are currently completing progressive strength training ≥2x/week (or have within <6 months of recruitment)
3. Planned travel and/or unable to attend >80% (missing ≥ 8 sessions) of the classes
4. Acute or chronic disease, in the opinion of the Investigator, that interfere with the participants capacity to exercise
5. Diabetes
6. Individuals who have undergone or who are currently undergoing cancer treatment in the last 5 years
7. Current smoker (smoking compromises exercise adaptation)
8. Any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements
9. Excessive alcohol consumption (>21 units/wk)
10. Routine/daily usage of any anabolic or cortico-steroid
11. Do not have access to the internet at home via a personal smartphone, tablet (e.g., iPad), or computer.
Date of first enrolment01/07/2023
Date of final enrolment01/04/2024

Locations

Countries of recruitment

  • Canada

Study participating centre

McMaster University
1280 Main Street West
Hamilton
L8S 4L8
Canada

Sponsor information

McMaster University
University/education

1280 Main Street West
Hamilton
L8S 4L8
Canada

Phone +1 (905) 525-9140
Email colettj@mcmaster.ca
Website https://www.mcmaster.ca/
ROR logo "ROR" https://ror.org/02fa3aq29

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date30/06/2025
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a peer-reviewed journal.
IPD sharing planThe data-sharing plans for the current study are unknown and will be made available at a later date.

Editorial Notes

23/08/2024: The following changes were made to the trial record:
1. The overall end date was changed from 31/08/2024 to 30/09/2024.
2. The intention to publish date was changed from 30/05/2025 to 30/06/2025.
3. The plain English summary was updated to reflect these changes.
01/08/2023: The sponsor has been changed from Hamilton Integrated Research Ethics Board (HiREB) to McMaster University.
27/06/2023: Trial's existence confirmed by Hamilton Integrated Research Ethics Board.