Home-based HIFST for Older Adults to Prevent Functional Decline

Mobility Limitation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05266911
• Other study ID #: 13879
• Status: Completed
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: September 15, 2023

Study information

• Verified date: September 2023
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 15, 2023
• Est. primary completion date: August 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Fall Injury
• Mobility Limitation

Intervention

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

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario
Canada	McMaster University	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Process Outcome: Self Efficacy for Exercise Scale (SEE)	Scale 0-90 (higher scores is greater self-efficacy)	pre and post intervention (12 weeks)
Other	Process Outcome: Activities Balance Confidence (ABC) Scale	0-100 percent, higher scores equals greater confidence	pre and post intervention (12 weeks)
Primary	Feasibility: Adherence	Percentage of exercise sessions completed (criteria: at least 70 precent)	over 12 weeks (intervention duration)
Primary	Feasibility: Recruitment	Percentage of eligible participants recruited (criteria: at least 65 precent)	4-6 month recruitment period
Primary	Feasibility: Retention	Percentage of participants completing baseline and follow-up assessments (criteria: at least 80 percent)	over 12 weeks
Primary	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	Physical Functioning: 4 meter walk test (	usual gait speed over 4 meters	pre and post intervention (12 weeks)
Secondary	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)
Secondary	Physical Functioning: Two minute step test (TMST)	number of steps in two minutes	pre and post intervention (12 weeks)
Secondary	Physical Functioning: 30-second chair stand test (30CST)	number of full stands from a chair in 30 seconds	pre and post intervention (12 weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Cognitive Functioning: Oral Trail Making Test (OTMT)	involves task-shifting (mental flexibility), attention, working memory and processing speed	pre and post intervention (12 weeks)
Secondary	Enjoyment: Physical Activity Enjoyment Scale (PACES)	Scale 8-56 (higher score is greater enjoyment)	week 1,2,4,6,8,10,12
Secondary	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
Secondary	Harms	any intervention-related adverse events (e.g., muscle soreness, muscle strains, etc.,) reported by participants	over 12 week intervention period