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Completed

NCT Number: NCT05266911

Home-based HIFST for Older Adults to Prevent Functional Decline

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.

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Key information

Conditions

Mobility Limitation Fall Injury Pathological Conditions, Signs and Symptoms Signs and Symptoms Slip and Fall

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

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

Treatment and study plan

high-intensity functional strength training

Behavioral

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 stretching

Behavioral

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

Primary outcomes

  1. Feasibility: Adherence

    Time frame: over 12 weeks (intervention duration)

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

  2. Feasibility: Recruitment

    Time frame: 4-6 month recruitment period

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

  3. Feasibility: Retention

    Time frame: over 12 weeks

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

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

    Time frame: over 12 weeks (intervention period)

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

Secondary outcomes

  1. Physical Functioning: 4 meter walk test (

    Time frame: pre and post intervention (12 weeks)

    usual gait speed over 4 meters

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

    Time frame: pre and post intervention (12 weeks)

    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

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

    Time frame: pre and post intervention (12 weeks)

    number of steps in two minutes

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

    Time frame: pre and post intervention (12 weeks)

    number of full stands from a chair in 30 seconds

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

    Time frame: pre and post intervention (12 weeks)

    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)

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

    Time frame: pre and post intervention (12 weeks)

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

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

    Time frame: pre and post intervention (12 weeks)

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

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

    Time frame: pre and post intervention (12 weeks)

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

  9. Enjoyment: Physical Activity Enjoyment Scale (PACES)

    Time frame: week 1,2,4,6,8,10,12

    Scale 8-56 (higher score is greater enjoyment)

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

    Time frame: week 1,2,4,6,8,10,12

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

  11. Harms

    Time frame: over 12 week intervention period

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

Other outcomes

  1. Process Outcome: Self Efficacy for Exercise Scale (SEE)

    Time frame: pre and post intervention (12 weeks)

    Scale 0-90 (higher scores is greater self-efficacy)

  2. Process Outcome: Activities Balance Confidence (ABC) Scale

    Time frame: pre and post intervention (12 weeks)

    0-100 percent, higher scores equals greater confidence

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 4, 2022
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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