Clinical trial NCT05266911: Home-based HIFST for Older Adults to Prevent Functional Decline
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobility Limitation
Fall Injury
Slip and Fall
Keywords: Preclinical Mobility Limitation
High-intensity Functional Strength Training
Feasibility
Physical Functioning
Cognitive Functioning
Enjoyment
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pilot randomized controlled trial and follow-up qualitative description study.
Primary purpose: PREVENTION

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

1. English-speaking, community-dwelling older adults ≥ 55 years, who
2. sustained an injury from a slip, trip or fall in the last year (assessed by self-report) and
3. as a result report decreased and/or modified daily task performance (assessed using PCML questionnaire based on Mänty) and Participants must have
4. 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Feasibility: Adherence
timeFrame: over 12 weeks (intervention duration)
measure: Feasibility: Recruitment
timeFrame: 4-6 month recruitment period
measure: Feasibility: Retention
timeFrame: over 12 weeks
measure: Feasibility: Safety (number/presence of intervention-related serious adverse events)
timeFrame: over 12 weeks (intervention period)
Secondary outcomes:
measure: Physical Functioning: 4 meter walk test (
timeFrame: pre and post intervention (12 weeks)
measure: Physical Functioning: dual-task cognitive Timed Up and Go (TUG-COG)
timeFrame: pre and post intervention (12 weeks)
measure: Physical Functioning: Two minute step test (TMST)
timeFrame: pre and post intervention (12 weeks)
measure: Physical Functioning: 30-second chair stand test (30CST)
timeFrame: pre and post intervention (12 weeks)
measure: Physical Functioning: Preclinical Mobility Limitation (PCML) scale
timeFrame: pre and post intervention (12 weeks)
measure: Cognitive Functioning: California Older Adult Stroop Test (COAST)
timeFrame: pre and post intervention (12 weeks)
measure: Cognitive Functioning: Digit Symbol Substitution Test (DSST)
timeFrame: pre and post intervention (12 weeks)
measure: Cognitive Functioning: Oral Trail Making Test (OTMT)
timeFrame: pre and post intervention (12 weeks)
measure: Enjoyment: Physical Activity Enjoyment Scale (PACES)
timeFrame: week 1,2,4,6,8,10,12
measure: Affective response to exercise: Feelings Scale (FS)
timeFrame: week 1,2,4,6,8,10,12
measure: Harms
timeFrame: over 12 week intervention period
Other outcomes:
measure: Process Outcome: Self Efficacy for Exercise Scale (SEE)
timeFrame: pre and post intervention (12 weeks)
measure: Process Outcome: Activities Balance Confidence (ABC) Scale
timeFrame: pre and post intervention (12 weeks)
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Julie Richardson, PhD
role: PRINCIPAL_INVESTIGATOR
References: