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Mobility LimitationNCT05266911

Home-based HIFST for Older Adults to Prevent Functional Decline

A study testing high-intensity functional strength training and Lower extremity stretching in people with Mobility Limitation and Fall Injury, run by McMaster University at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

After an injury, an older adult may experience changes to how they complete their daily activities and participate in physical activity. Changes in how or how often an older adult performs an activity (such as climbing the stairs) can be warning signs of increased future difficulties. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Mobility Limitation, Fall Injury, Slip and Fall
What is being tested?
high-intensity functional strength training and Lower extremity stretching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesCanada
Study dates
21 Mar 2022to 15 Sep 2023
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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • English-speaking, community-dwelling older adults ≥ 55 years, who
  • sustained an injury from a slip, trip or fall in the last year (assessed by self-report) and
  • as a result report decreased and/or modified daily task performance (assessed using PCML questionnaire based on Mänty) and Participants must have
  • no contraindications to exercise based on the American College for Sports Medicine recommendations and 5) complete the Canadian Society for Exercise Physiology (CSEP) 'Get Active' questionnaire and obtain clearance from a health care professional if deemed necessary based on screening.
  • 6) Participants will be required to have access to email and a laptop/tablet with webcam capable of running the web-based videoconferencing platform Zoom well as 7) the ability to provide informed consent.

Who cannot join

  • 1) a score of < 11 on the Mini Montreal Cognitive Assessment (Mini MoCa).

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • McMaster University

    Hamilton, Ontario, L8S1C7

  • McMaster University

    Hamilton, Ontario, L8W3Y8

Other trials in Canada

About this study

Official title: Home-based High Intensity Functional Strength Training (HIFST) for Older Adults: A Pilot Randomized Controlled Trial of an Exercise Program to Prevent Functional Decline After an Injury

After an injury, an older adult may experience changes to how they complete their daily activities and participate in physical activity. Changes in how or how often an older adult performs an activity (such as climbing the stairs) can be warning signs of increased future difficulties. The purpose of this study is to prevent this decline by providing an exercise program for older adults experiencing these changes. This pilot study will determine if a 12-week home-based high intensity functional strength training (HIFST) program is feasible for older adults who have had an injury from a slip, trip, or fall. HIFST involves combining periods of performing 'hard' everyday movements to build strength (for example standing and sitting from a chair) with periods of rest or 'easy' activity. Feasibility will be determined based on the amount of recommended exercise sessions people complete, the ability to enroll participants and have them finish the program, as well as demonstration of safety. The study will also measure the effects on physical functioning, cognitive functioning, and enjoyment. Interviews with participants in the HIFST program will be conducted after the 12-weeks to gather information on their experience, opinions, likes/dislikes, and suggestions. All this information will be used to guide a future larger study to determine effectiveness.

Read the detailed description

An injury from a slip, trip or fall in an older adult may instigate the onset of preclinical mobility limitation (PCML) which is a period of time in which modifications in task performance are indicative of an early stage of functional decline. Effective and enjoyable exercise interventions, which may be offered by home-based high-intensity functional strength training (HIFST), are needed during this period. More research is needed on the feasibility of conducting a home-based HIFST in a this group as well it's effects on physical functioning, cognitive functioning and enjoyment. This information, in conjunction with follow-up interviews to asses acceptability, will be used to inform plans of a future fully-powered trial to assess effectiveness.

The primary objective of this trial is to determine the feasibility of 12 weeks of home-based HIFST for community-dwelling older adults who are post-injury as determined by adherence, recruitment, retention, and safety criteria. The secondary objectives are to determine preliminary evidence of effects on physical functioning, cognitive functioning (specifically executive functions and processing speed) and physical activity enjoyment. The investigators will also report any intervention-related adverse events (harms, such as muscle strains, sprains, etc.). The follow-up qualitative study will assess acceptability of the intervention including barriers/facilitators to participation and recommendations for changes.

Being tested
high-intensity functional strength training, Lower extremity stretching
Keywords
Preclinical Mobility Limitation, High-intensity Functional Strength Training, Feasibility, Physical Functioning, Cognitive Functioning, Enjoyment
Medical subject headings
Mobility Limitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • high-intensity functional strength trainingBehavioural

    HIFST is an exercise program using an interval format: alternating periods of high intensity/'hard' exercise using everyday lower-extremity based strength-building movements (e.g., sit to stand) with periods of light/'easy' activity. High-intensity is individualized based on the use of a rating of perceived exertion (RPE) scale. The program includes a warm-up and cool-down and will be completed in participant's homes 3 days per week.

  • Lower extremity stretchingBehavioural

    Lower extremity stretching program to be completed by participants at home 3 days per week.

Study groups in NCT05266911
Study groupRoleWhat they receive
High-intensity strength training (HIFST) programExperimentalHome-based high-intensity strength training program
Receives: Behavioral: high-intensity functional strength training
Lower extremity stretching programActive comparatorLower extremity stretching program
Receives: Behavioral: Lower extremity stretching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility: Adherence

    Percentage of exercise sessions completed (criteria: at least 70 precent)

    Measured: over 12 weeks (intervention duration)

  2. Feasibility: Recruitment

    Percentage of eligible participants recruited (criteria: at least 65 precent)

    Measured: 4-6 month recruitment period

  3. Feasibility: Retention

    Percentage of participants completing baseline and follow-up assessments (criteria: at least 80 percent)

    Measured: over 12 weeks

  4. Feasibility: Safety (number/presence of intervention-related serious adverse events)

    Adverse events related to intervention (criteria: no serious events)

    Measured: over 12 weeks (intervention period)

Secondary outcomes (11)

  1. Physical Functioning: 4 meter walk test (

    usual gait speed over 4 meters

    Measured: pre and post intervention (12 weeks)

  2. Physical Functioning: dual-task cognitive Timed Up and Go (TUG-COG)

    time to rise from a standard chair, walk 3 meters, turn around, walk back to the chair and sit down while counting backwards by three

    Measured: pre and post intervention (12 weeks)

  3. Physical Functioning: Two minute step test (TMST)

    number of steps in two minutes

    Measured: pre and post intervention (12 weeks)

  4. Physical Functioning: 30-second chair stand test (30CST)

    number of full stands from a chair in 30 seconds

    Measured: pre and post intervention (12 weeks)

  5. Physical Functioning: Preclinical Mobility Limitation (PCML) scale

    classified as no mobility limitation, preclinical mobility limitation, minor manifest limitation or major manifest limitation for 3 tasks (walking 0.5km, walking 2 km, and climbing one flight of stairs)

    Measured: pre and post intervention (12 weeks)

  6. Cognitive Functioning: California Older Adult Stroop Test (COAST)

    measures executive functioning by assessing the ability to inhibit an automatic response

    Measured: pre and post intervention (12 weeks)

  7. Cognitive Functioning: Digit Symbol Substitution Test (DSST)

    assesses various aspects of cognition, including processing speed and several aspects of executive functioning (planning, attention, and working memory)

    Measured: pre and post intervention (12 weeks)

  8. Cognitive Functioning: Oral Trail Making Test (OTMT)

    involves task-shifting (mental flexibility), attention, working memory and processing speed

    Measured: pre and post intervention (12 weeks)

  9. Enjoyment: Physical Activity Enjoyment Scale (PACES)

    Scale 8-56 (higher score is greater enjoyment)

    Measured: week 1,2,4,6,8,10,12

  10. Affective response to exercise: Feelings Scale (FS)

    Scale +5 to -5 (+5 very good, -5 very bad)

    Measured: week 1,2,4,6,8,10,12

  11. Harms

    any intervention-related adverse events (e.g., muscle soreness, muscle strains, etc.,) reported by participants

    Measured: over 12 week intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2022
  2. Study start21 Mar 2022
  3. Primary completion27 Aug 2023
  4. Study completion15 Sep 2023

Resources

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
Model description
A pilot randomized controlled trial and follow-up qualitative description study.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05266911
Sponsor's protocol ID
13879
Status last verified
Sep 2023
First submitted
28 Jan 2022
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing high-intensity functional strength training and Lower extremity stretching in people with Mobility Limitation and Fall Injury, run by McMaster University at 2 sites 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 5 inclusion and 1 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Feasibility: Adherence (time frame: over 12 weeks (intervention duration)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05266911.

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 21 Sep 2023.

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