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Home-based HIFST for Older Adults to Prevent Functional Decline

Primary Purpose

Mobility Limitation, Fall Injury, Slip and Fall

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
high-intensity functional strength training
Lower extremity stretching
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mobility Limitation focused on measuring Preclinical Mobility Limitation, High-intensity Functional Strength Training, Feasibility, Physical Functioning, Cognitive Functioning, Enjoyment

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 six months (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
  4. are not currently meeting Canadian Physical Activity guidelines (150 minutes of moderate-vigorous activity per week.) Participants must have
  5. no contraindications to exercise based on the American College for Sports Medicine recommendations and 6) 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.

7) Participants will be required to have access to email and a laptop with webcam capable of running the web-based videoconferencing platform Zoom well as 8) the ability to provide informed consent.

Exclusion Criteria:

1) currently participating in an organized general exercise program (this does not include participation in injury-specific rehabilitation) or have 2) a score of < 11 on the Mini Montreal Cognitive Assessment (Mini MoCa).

Sites / Locations

  • McMaster University
  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-intensity strength training (HIFST) program

Lower extremity stretching program

Arm Description

Home-based high-intensity strength training program

Lower extremity stretching program

Outcomes

Primary Outcome Measures

Feasibility: Adherence
Percentage of exercise sessions completed (criteria: at least 70 precent)
Feasibility: Recruitment
Percentage of eligible participants recruited (criteria: at least 65 precent)
Feasibility: Retention
Percentage of participants completing baseline and follow-up assessments (criteria: at least 80 percent)
Feasibility: Safety (number/presence of intervention-related serious adverse events)
Adverse events related to intervention (criteria: no serious events)

Secondary Outcome Measures

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

Full Information

First Posted
January 28, 2022
Last Updated
September 18, 2023
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT05266911
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
August 27, 2023 (Actual)
Study Completion Date
September 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation, Fall Injury, Slip and Fall
Keywords
Preclinical Mobility Limitation, High-intensity Functional Strength Training, Feasibility, Physical Functioning, Cognitive Functioning, Enjoyment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A pilot randomized controlled trial and follow-up qualitative description study.
Masking
Outcomes Assessor
Masking Description
statistical analysis for secondary outcomes
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-intensity strength training (HIFST) program
Arm Type
Experimental
Arm Description
Home-based high-intensity strength training program
Arm Title
Lower extremity stretching program
Arm Type
Active Comparator
Arm Description
Lower extremity stretching program
Intervention Type
Behavioral
Intervention Name(s)
high-intensity functional strength training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lower extremity stretching
Intervention Description
Lower extremity stretching program to be completed by participants at home 3 days per week.
Primary Outcome Measure Information:
Title
Feasibility: Adherence
Description
Percentage of exercise sessions completed (criteria: at least 70 precent)
Time Frame
over 12 weeks (intervention duration)
Title
Feasibility: Recruitment
Description
Percentage of eligible participants recruited (criteria: at least 65 precent)
Time Frame
4-6 month recruitment period
Title
Feasibility: Retention
Description
Percentage of participants completing baseline and follow-up assessments (criteria: at least 80 percent)
Time Frame
over 12 weeks
Title
Feasibility: Safety (number/presence of intervention-related serious adverse events)
Description
Adverse events related to intervention (criteria: no serious events)
Time Frame
over 12 weeks (intervention period)
Secondary Outcome Measure Information:
Title
Physical Functioning: 4 meter walk test (
Description
usual gait speed over 4 meters
Time Frame
pre and post intervention (12 weeks)
Title
Physical Functioning: dual-task cognitive Timed Up and Go (TUG-COG)
Description
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
Time Frame
pre and post intervention (12 weeks)
Title
Physical Functioning: Two minute step test (TMST)
Description
number of steps in two minutes
Time Frame
pre and post intervention (12 weeks)
Title
Physical Functioning: 30-second chair stand test (30CST)
Description
number of full stands from a chair in 30 seconds
Time Frame
pre and post intervention (12 weeks)
Title
Physical Functioning: Preclinical Mobility Limitation (PCML) scale
Description
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)
Time Frame
pre and post intervention (12 weeks)
Title
Cognitive Functioning: California Older Adult Stroop Test (COAST)
Description
measures executive functioning by assessing the ability to inhibit an automatic response
Time Frame
pre and post intervention (12 weeks)
Title
Cognitive Functioning: Digit Symbol Substitution Test (DSST)
Description
assesses various aspects of cognition, including processing speed and several aspects of executive functioning (planning, attention, and working memory)
Time Frame
pre and post intervention (12 weeks)
Title
Cognitive Functioning: Oral Trail Making Test (OTMT)
Description
involves task-shifting (mental flexibility), attention, working memory and processing speed
Time Frame
pre and post intervention (12 weeks)
Title
Enjoyment: Physical Activity Enjoyment Scale (PACES)
Description
Scale 8-56 (higher score is greater enjoyment)
Time Frame
week 1,2,4,6,8,10,12
Title
Affective response to exercise: Feelings Scale (FS)
Description
Scale +5 to -5 (+5 very good, -5 very bad)
Time Frame
week 1,2,4,6,8,10,12
Title
Harms
Description
any intervention-related adverse events (e.g., muscle soreness, muscle strains, etc.,) reported by participants
Time Frame
over 12 week intervention period
Other Pre-specified Outcome Measures:
Title
Process Outcome: Self Efficacy for Exercise Scale (SEE)
Description
Scale 0-90 (higher scores is greater self-efficacy)
Time Frame
pre and post intervention (12 weeks)
Title
Process Outcome: Activities Balance Confidence (ABC) Scale
Description
0-100 percent, higher scores equals greater confidence
Time Frame
pre and post intervention (12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Richardson, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S1C7
Country
Canada
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8W3Y8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Home-based HIFST for Older Adults to Prevent Functional Decline

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