Frail ElderlyNCT02593084
Resistance Training to Optimize Health in Pre-frail Older Adults
A study testing Higher Intensity Resistance Training and Lower Intensity Resistance Training in people with Frail Elderly, run by McMaster University at 1 site in Canada.
Trial summary
Exercise programs, particularly resistance training programs using weights or resistance bands, can help improve or maintain mobility and function in older adults, preserve independent living, and improve quality of life. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frail Elderly
- What is being tested?
- Higher Intensity Resistance Training and Lower Intensity Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self-reported mobility limitations
- living in the community
- not currently engaged in regular resistance training
- able to follow instructions
Who cannot join
- contraindications for intensive resistance training (e.g. recent cardiovascular event, fracture within the past 12 months)
- musculoskeletal injuries for which intervention participants are receiving concomitant rehabilitation treatments
Trial locations and contacts
1 site in 1 country.
About this study
Exercise programs, particularly resistance training programs using weights or resistance bands, can help improve or maintain mobility and function in older adults, preserve independent living, and improve quality of life. This study will examine the safety and feasibility of a novel, higher intensity resistance training program in older adults, and compare the effects with standard care, lower intensity training. It is anticipated that both programs will be safe and feasible, but higher-intensity training will lead to greater improvements in quality of life, mobility and strength, which are part of the physical phenotype definition of frailty and markers of mobility disability.
Read the detailed description
It is critically important to identify effective strategies to reduce the risk and impact of mobility disability and frailty in older adults. Exercise, particularly resistance training (RT), has the potential to influence a person's ability to navigate around their environment and impact the components of the frailty phenotype which include weakness, physical inactivity, and slowness. Higher training intensities have been used with athletes and younger adults to achieve greater gains in strength, but the feasibility and effectiveness is less established in older persons who exhibit preclinical disability, or are at-risk for mobility decline where conservative protocols are typically employed. Higher intensity RT may be an innovative and effective strategy in preclinical disability pre-frailty to reduce the risk and impact of future frailty and mobility decline.
This study aims to examine: 1) the safety and feasibility of a 12-week higher intensity RT protocol in community dwelling older adults at risk for mobility disability, and 2) the effects of this protocol on walking, balance, muscle strength, quality of life compared to lower intensity RT
It is hypothesized that the higher intensity RT: 1) is safe and feasible for at-risk community-dwelling older adults, 2) more effective in improving walking, balance, muscle strength, and quality of life than lower intensity RT
- Conditions
- Frail Elderly
- Being tested
- Higher Intensity Resistance Training, Lower Intensity Resistance Training
- Keywords
- Resistance Training, Exercise, Walking, Safety, Feasibility Studies
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Higher Intensity Resistance TrainingBehavioural
Also called HEaRT
Bi-weekly resistance training for 12 weeks using multi-joint movements involving both upper and lower extremities (e.g squats). Participants will perform 3-5 sets of 3-6 repetitions at Rating of Perceived Exertion 8/10. The intervention will be administered by a Physical Therapist or trained fitness professional.
Lower Intensity Resistance TrainingBehavioural
Also called LRT
Bi-weekly resistance training for 12 weeks using single-joint movements involving both upper and lower extremities (e.g leg extension). Participants will perform 3-5 sets of 8-10 repetitions at Rating of Perceived Exertion 5/10. The intervention will be administered by a Physical Therapist or trained fitness professional.
| Study group | Role | What they receive |
|---|---|---|
| Higher Intensity Resistance Training | Experimental | Participants will take part in a 12-week higher-intensity resistance training protocol. Receives: Behavioral: Higher Intensity Resistance Training |
| Lower Intensity Resistance Training | Active comparator | Participants will take part in a 12-week lower-intensity resistance training protocol that will serve as the active comparator. Receives: Behavioral: Lower Intensity Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events
Measured: Entire duration of the intervention (12 weeks)
Attendance rate
Measured: Entire duration of the intervention (12 weeks)
Attrition rate
Measured: Entire duration of the intervention (12 weeks)
Secondary outcomes (10)
Timed Up and Go Test
Measured: 0, 12, 20 weeks
Short Physical Performance Battery
Measured: 0, 12, 20 weeks
Berg Balance Scale
Measured: 0, 12, 20 weeks
Activities-Specific Balance Confidence scale
Measured: 0, 12, 20 weeks
Muscle strength
Measured: 0, 12, 20 weeks
Short Form-36
Measured: 0, 12, 20 weeks
Caregiver Burden Interview Short Form
Measured: 0, 12, 20 weeks
Healthcare Utilization Questionnaires
Measured: 0, 12, 20 weeks
Peripheral Quantitative Computed Tomography analysis of muscle and bone quality
Measured: 0, 12, 20 weeks
EQ-5D-5L
Measured: 0, 12, 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail ElderlyStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Frailty Network
- Responsible party
- Sponsor
- Investigators
- Ada Tang, PT PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593084
- Sponsor's protocol ID
- CAT2015-19
- Status last verified
- Mar 2018
- First submitted
- 27 Oct 2015
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Training to Optimize Health in Pre-frail Older Adults
- ClinicalTrials.gov ID
- NCT02593084
- Acronym / sponsor ID
- CAT2015-19
- Conditions
- Frail Elderly
- Keywords
- Resistance Training, Exercise, Walking, Safety, Feasibility Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Frailty Network
- Study start
- Jan 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exercise programs, particularly resistance training programs using weights or resistance bands, can help improve or maintain mobility and function in older adults, preserve independent living, and improve quality of life. This study will examine the safety and feasibility of a novel, higher intensity resistance training program in older adults, and compare the effects with standard care, lower intensity training. It is anticipated that both programs will be safe and feasible, but higher-intensity training will lead to greater improvements in quality of life, mobility and strength, which are part of the physical phenotype definition of frailty and markers of mobility disability.
Detailed description
It is critically important to identify effective strategies to reduce the risk and impact of mobility disability and frailty in older adults. Exercise, particularly resistance training (RT), has the potential to influence a person's ability to navigate around their environment and impact the components of the frailty phenotype which include weakness, physical inactivity, and slowness. Higher training intensities have been used with athletes and younger adults to achieve greater gains in strength, but the feasibility and effectiveness is less established in older persons who exhibit preclinical disability, or are at-risk for mobility decline where conservative protocols are typically employed. Higher intensity RT may be an innovative and effective strategy in preclinical disability pre-frailty to reduce the risk and impact of future frailty and mobility decline.
This study aims to examine: 1) the safety and feasibility of a 12-week higher intensity RT protocol in community dwelling older adults at risk for mobility disability, and 2) the effects of this protocol on walking, balance, muscle strength, quality of life compared to lower intensity RT
It is hypothesized that the higher intensity RT: 1) is safe and feasible for at-risk community-dwelling older adults, 2) more effective in improving walking, balance, muscle strength, and quality of life than lower intensity RT
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Higher Intensity Resistance Training | Experimental | Behavioral: Higher Intensity Resistance TrainingParticipants will take part in a 12-week higher-intensity resistance training protocol. |
| Lower Intensity Resistance Training | Active comparator | Behavioral: Lower Intensity Resistance TrainingParticipants will take part in a 12-week lower-intensity resistance training protocol that will serve as the active comparator. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- self-reported mobility limitations
- living in the community
- not currently engaged in regular resistance training
- able to follow instructions
Key exclusion criteria (2 listed)
- contraindications for intensive resistance training (e.g. recent cardiovascular event, fracture within the past 12 months)
- musculoskeletal injuries for which intervention participants are receiving concomitant rehabilitation treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Higher Intensity Resistance TrainingAlso: HEaRTBi-weekly resistance training for 12 weeks using multi-joint movements involving both upper and lower extremities (e.g squats). Participants will perform 3-5 sets of 3-6 repetitions at Rating of Perceived Exertion 8/10. The intervention will be administered by a Physical Therapist or trained fitness professional. | Behavioural | Higher Intensity Resistance Training |
| Lower Intensity Resistance TrainingAlso: LRTBi-weekly resistance training for 12 weeks using single-joint movements involving both upper and lower extremities (e.g leg extension). Participants will perform 3-5 sets of 8-10 repetitions at Rating of Perceived Exertion 5/10. The intervention will be administered by a Physical Therapist or trained fitness professional. | Behavioural | Lower Intensity Resistance Training |
Primary outcome
Occurrence of adverse events
Time frame: Entire duration of the intervention (12 weeks)
Attendance rate
Time frame: Entire duration of the intervention (12 weeks)
Attrition rate
Time frame: Entire duration of the intervention (12 weeks)
10 secondary outcomes
Timed Up and Go Test
Time frame: 0, 12, 20 weeks
Short Physical Performance Battery
Time frame: 0, 12, 20 weeks
Berg Balance Scale
Time frame: 0, 12, 20 weeks
Activities-Specific Balance Confidence scale
Time frame: 0, 12, 20 weeks
Muscle strength
Time frame: 0, 12, 20 weeks
Short Form-36
Time frame: 0, 12, 20 weeks
Caregiver Burden Interview Short Form
Time frame: 0, 12, 20 weeks
Healthcare Utilization Questionnaires
Time frame: 0, 12, 20 weeks
Peripheral Quantitative Computed Tomography analysis of muscle and bone quality
Time frame: 0, 12, 20 weeks
EQ-5D-5L
Time frame: 0, 12, 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ada Tang, PT PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Higher Intensity Resistance Training and Lower Intensity Resistance Training in people with Frail Elderly, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse events (time frame: Entire duration of the intervention (12 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.