Home-based HIFST for Older Adults to Prevent Functional Decline

NCT05266911 | Completed

• 1 other identifier: 13879
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Mobility Limitation; Fall Injury; Slip and Fall

Keywords

Preclinical Mobility Limitation; High-intensity Functional Strength Training; Feasibility; Physical Functioning; Cognitive Functioning; Enjoyment

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (11)

• Physical Functioning: 4 meter walk test (

  pre and post intervention (12 weeks)

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

  pre and post intervention (12 weeks)

• Physical Functioning: Two minute step test (TMST)

  pre and post intervention (12 weeks)

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

  pre and post intervention (12 weeks)

• Physical Functioning: Preclinical Mobility Limitation (PCML) scale

  pre and post intervention (12 weeks)

Other Outcomes (2)

• Process Outcome: Self Efficacy for Exercise Scale (SEE)

  pre and post intervention (12 weeks)

• Process Outcome: Activities Balance Confidence (ABC) Scale

  pre and post intervention (12 weeks)

Study Arms (2)

High-intensity strength training (HIFST) program

EXPERIMENTAL

Home-based high-intensity strength training program

Behavioral: high-intensity functional strength training

Lower extremity stretching program

ACTIVE COMPARATOR

Lower extremity stretching program

Behavioral: Lower extremity stretching

Interventions

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.

High-intensity strength training (HIFST) program

Lower extremity stretching BEHAVIORAL

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

Lower extremity stretching program

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (2)

McMaster University

Hamilton, Ontario, L8S1C7, Canada

Location

McMaster University

Hamilton, Ontario, L8W3Y8, Canada

Location

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie Richardson, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: statistical analysis for secondary outcomes
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A pilot randomized controlled trial and follow-up qualitative description study.

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: March 4, 2022
• Study Start: March 21, 2022
• Primary Completion: August 27, 2023
• Study Completion: September 15, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)