Home-based HIFST for Older Adults to Prevent Functional Decline

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.

Study Overview

• Status: Completed
• Conditions: Mobility Limitation; Fall Injury; Slip and Fall
• Intervention / Treatment: Behavioral: high-intensity functional strength training; Behavioral: Lower extremity stretching

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashley Morgan, MSc(PT); Phone Number: 905-525-9140; Email: morgaa2@mcmaster.ca
• Study Contact Backup: Name: Julie Richardson, PhD; Phone Number: 905-525-9140; Email: jrichard@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S1C7
      • McMaster University
    • Hamilton, Ontario, Canada, L8W3Y8
      • McMaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-intensity strength training (HIFST) program; Home-based high-intensity strength training program	Behavioral: high-intensity functional strength training; 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.
Active Comparator: Lower extremity stretching program	Behavioral: Lower extremity stretching; Lower extremity stretching program to be completed by participants at home 3 days per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Adherence	Percentage of exercise sessions completed (criteria: at least 70 precent)	over 12 weeks (intervention duration)
Feasibility: Recruitment	Percentage of eligible participants recruited (criteria: at least 65 precent)	4-6 month recruitment period
Feasibility: Retention	Percentage of participants completing baseline and follow-up assessments (criteria: at least 80 percent)	over 12 weeks
Feasibility: Safety (number/presence of intervention-related serious adverse events)	Adverse events related to intervention (criteria: no serious events)	over 12 weeks (intervention period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Functioning: 4 meter walk test (	usual gait speed over 4 meters	pre and post intervention (12 weeks)
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	pre and post intervention (12 weeks)
Physical Functioning: Two minute step test (TMST)	number of steps in two minutes	pre and post intervention (12 weeks)
Physical Functioning: 30-second chair stand test (30CST)	number of full stands from a chair in 30 seconds	pre and post intervention (12 weeks)
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)	pre and post intervention (12 weeks)
Cognitive Functioning: California Older Adult Stroop Test (COAST)	measures executive functioning by assessing the ability to inhibit an automatic response	pre and post intervention (12 weeks)
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)	pre and post intervention (12 weeks)
Cognitive Functioning: Oral Trail Making Test (OTMT)	involves task-shifting (mental flexibility), attention, working memory and processing speed	pre and post intervention (12 weeks)
Enjoyment: Physical Activity Enjoyment Scale (PACES)	Scale 8-56 (higher score is greater enjoyment)	week 1,2,4,6,8,10,12
Affective response to exercise: Feelings Scale (FS)	Scale +5 to -5 (+5 very good, -5 very bad)	week 1,2,4,6,8,10,12
Harms	any intervention-related adverse events (e.g., muscle soreness, muscle strains, etc.,) reported by participants	over 12 week intervention period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Process Outcome: Self Efficacy for Exercise Scale (SEE)	Scale 0-90 (higher scores is greater self-efficacy)	pre and post intervention (12 weeks)
Process Outcome: Activities Balance Confidence (ABC) Scale	0-100 percent, higher scores equals greater confidence	pre and post intervention (12 weeks)

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Julie Richardson, PhD, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Actual): August 27, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Feasibility; Physical Functioning; Cognitive Functioning; Enjoyment; Preclinical Mobility Limitation; High-intensity Functional Strength Training
• Additional Relevant MeSH Terms: Mobility Limitation
• Other Study ID Numbers: 13879

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No