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Reducing Falls With Progressive Resistance Training for the Oldest Old Adults With Sarcopenia (ReFit)

Primary Purpose

Sarcopenia, Aging

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
High-intensity progressive resistance training
General practitioner care
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia

Eligibility Criteria

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

Inclusion Criteria: Aged 80 years or older Low muscular strength (grip strength: <34.8 kg for males and <18.8 kg for females or chair stand >15 seconds) Community-dwelling incl. independent senior housing Ambulatory without supervision or physical assistance from another person. Assistive devices such as canes/crutches/walkers allowed. Able to see and hear sufficiently to undertake assessments and partake in the planned exercise training. Exclusion Criteria: Pre-existing diagnosis of dementia Moderate or severe cognitive impairment (score <18 on the Mini-Mental State Examination) Living in institutional care Non-ambulatory or requiring person or wheelchair to assist when walking Degenerative neurological and neuromuscular disease/disorder significantly influencing gait and mobility (e.g. amyotrophic lateral sclerosis [ALS] and Parkinson's disease). Amputation (other than toes) Contraindications to resistance training Unstable fracture Inability to comply with study requirements Currently undertaking progressive resistance training

Sites / Locations

  • Department of Circulation and Medical Imaging

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Progressive resistance training

Control

Arm Description

Twice weekly high-intensity progressive resistance training for 12 months

Referred to general practitioner

Outcomes

Primary Outcome Measures

Falls
Relative risk for falls, fall rate per person years. Self-report.

Secondary Outcome Measures

Falls
Relative risk for falls, fall rate per person years. Self-report.
Falls
Number of falls, number of fallers/nonfallers/frequent fallers, and time to first fall. Self-report.
Falls requiring medical attention
Number of falls requiring medical attention. Collected via self-report and ascertained by linkage to the Norwegian Patient Registry and medical journals with the use of unique 11-digit Norwegian national identification number for each participant.
Fall-related injuries
Classified according to the International Classification of Diseases, 11th revision, classification system. Peripheral fracture rate per person-years, number of peripheral fractures, number of people sustaining peripheral fractures, and number of people sustaining multiple events. Collected via self-report and ascertained by linkage to the Norwegian Patient Registry and medical journals with the use of unique 11-digit Norwegian national identification number for each participant.
Dynamic muscular strength
1-repetition maximum leg press and leg extension
Grip strength
Maximal isometric handgrip strength
Muscular power
Muscular power assessed using a force platform installed on a leg press machine
Physical performance
Physical performance using the Short Physical Performance Battery
Gait characteristics
Gait characteristics during a 4-m walk on the GAITrite electronic gait mat
Balance
Static and dynamic balance using the Mini-Balance Evaluation Systems Test (BESTest) and a 3-m tandem walk
Stature
Stretch stature using a wall-mounted stadiometer
Body mass
Body mass estimated using multi-frequency bioelectrical impedance analysis
Body composition
Estimated using multi-frequency bioelectrical impedance analysis. Fat mass, skeletal muscle mss, appendicular skeletal muscle mass.
Circumferences
Waist, arm, and calf circumference
Resting blood pressure and resting heart rate
Systolic and diastolic blood pressure, and resting heart rate measured after 5 minutes of seated resting using an automated blood pressure device
Orthostatic blood pressure
Systolic and diastolic blood pressure response 1, and 3-min after standing up
Physical activity
Self-reported physical activity levels
Health-related quality of life
Health-related quality of life assessed using the 12-item Short-form health survey
Fear of falling
Fear of falling assessed using the Falls Efficacy Scale-International
Cognitive function
Cognitive function evaluated using The Mini Mental State Examination
Depression
Levels of depression measured via the Geriatric Depression Scale.
Frailty
Physical frailty assessed according to Fried's frailty phenotype
Nutritional status
Nutritional status assessed using the Mini-nutritional Assessment Short form.
Sleep quality
Sleep quality assessed using the Pittsburgh Sleep Quality Index
Hospital admissions
Information about hospitalisations due to falls and fall-related injuries will be collected by means of electronic linkage to the Norwegian Patient Registry and medical journals with the use of a unique 11-digit Norwegian national identification number for each participant.
Use of primary health care, community care, and assistive technology
Use of primary health care (general practitioner, emergency room, physiotherapist, and chiropractor), community care, and assistive technology during the study will be collected by linkage to the Norwegian Municipal Patient and User Register (KPR) database with the use of a unique 11-digit Norwegian national identification number for each participant.
Use of prescription drugs
Use of prescription drugs during the study will be collected by linkage to the Norwegian Prescribed Drug Registry with the use of a unique 11-digit Norwegian national identification number for each participant.

Full Information

First Posted
December 16, 2022
Last Updated
May 11, 2023
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05691166
Brief Title
Reducing Falls With Progressive Resistance Training for the Oldest Old Adults With Sarcopenia
Acronym
ReFit
Official Title
Reducing Falls With Progressive Resistance Training (ReFit) for the Oldest Old Adults With Sarcopenia. A 12-month Randomised Controlled Trial (RCT).
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

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
This study will investigate the effects of 12 months of high-intensity progressive resistance training compared with a control group on fall-rate in older adults with sarcopenia.
Detailed Description
Despite the wealth of theoretical benefits, existing literature on resistance training for falls prevention is not conclusive, given the sub-optimal resistance training paradigms, poor study quality, and use of multimodal training interventions, precluding isolation of the resistance training benefits. It is also possible that resistance training benefits for falls reduction will be most evident in those with sarcopenia to begin with as a risk factor for their falls. We will therefore conduct a randomised, controlled trial assessing the effects of resistance training reduce falls in the oldest old adults with sarcopenia, as well as to increase strength and muscle mass.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Aging

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Progressive resistance training
Arm Type
Experimental
Arm Description
Twice weekly high-intensity progressive resistance training for 12 months
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Referred to general practitioner
Intervention Type
Behavioral
Intervention Name(s)
High-intensity progressive resistance training
Intervention Description
Supervised high-intensity progressive resistance training twice per week for 12 months
Intervention Type
Other
Intervention Name(s)
General practitioner care
Intervention Description
Referred to general practitioner (GP) for further follow-up. The GPs will be informed about participants sarcopenia status with results from assessments of muscle strength, muscle mass, and physical performance. The management of the sarcopenia is at the GPs own discretion.
Primary Outcome Measure Information:
Title
Falls
Description
Relative risk for falls, fall rate per person years. Self-report.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Falls
Description
Relative risk for falls, fall rate per person years. Self-report.
Time Frame
6 months
Title
Falls
Description
Number of falls, number of fallers/nonfallers/frequent fallers, and time to first fall. Self-report.
Time Frame
6 and 12 months
Title
Falls requiring medical attention
Description
Number of falls requiring medical attention. Collected via self-report and ascertained by linkage to the Norwegian Patient Registry and medical journals with the use of unique 11-digit Norwegian national identification number for each participant.
Time Frame
6 and 12 months
Title
Fall-related injuries
Description
Classified according to the International Classification of Diseases, 11th revision, classification system. Peripheral fracture rate per person-years, number of peripheral fractures, number of people sustaining peripheral fractures, and number of people sustaining multiple events. Collected via self-report and ascertained by linkage to the Norwegian Patient Registry and medical journals with the use of unique 11-digit Norwegian national identification number for each participant.
Time Frame
6 and 12 months
Title
Dynamic muscular strength
Description
1-repetition maximum leg press and leg extension
Time Frame
6 and 12 months
Title
Grip strength
Description
Maximal isometric handgrip strength
Time Frame
6 and 12 months
Title
Muscular power
Description
Muscular power assessed using a force platform installed on a leg press machine
Time Frame
6 and 12 months
Title
Physical performance
Description
Physical performance using the Short Physical Performance Battery
Time Frame
6 and 12 months
Title
Gait characteristics
Description
Gait characteristics during a 4-m walk on the GAITrite electronic gait mat
Time Frame
6 and 12 months
Title
Balance
Description
Static and dynamic balance using the Mini-Balance Evaluation Systems Test (BESTest) and a 3-m tandem walk
Time Frame
6 and 12 months
Title
Stature
Description
Stretch stature using a wall-mounted stadiometer
Time Frame
6 and 12 months
Title
Body mass
Description
Body mass estimated using multi-frequency bioelectrical impedance analysis
Time Frame
6 and 12 months
Title
Body composition
Description
Estimated using multi-frequency bioelectrical impedance analysis. Fat mass, skeletal muscle mss, appendicular skeletal muscle mass.
Time Frame
6 and 12 months
Title
Circumferences
Description
Waist, arm, and calf circumference
Time Frame
6 and 12 months
Title
Resting blood pressure and resting heart rate
Description
Systolic and diastolic blood pressure, and resting heart rate measured after 5 minutes of seated resting using an automated blood pressure device
Time Frame
6 and 12 months
Title
Orthostatic blood pressure
Description
Systolic and diastolic blood pressure response 1, and 3-min after standing up
Time Frame
6 and 12 months
Title
Physical activity
Description
Self-reported physical activity levels
Time Frame
6 and 12 months
Title
Health-related quality of life
Description
Health-related quality of life assessed using the 12-item Short-form health survey
Time Frame
6 and 12 months
Title
Fear of falling
Description
Fear of falling assessed using the Falls Efficacy Scale-International
Time Frame
6 and 12 months
Title
Cognitive function
Description
Cognitive function evaluated using The Mini Mental State Examination
Time Frame
6 and 12 months
Title
Depression
Description
Levels of depression measured via the Geriatric Depression Scale.
Time Frame
6 and 12 months
Title
Frailty
Description
Physical frailty assessed according to Fried's frailty phenotype
Time Frame
6 and 12 months
Title
Nutritional status
Description
Nutritional status assessed using the Mini-nutritional Assessment Short form.
Time Frame
6 and 12 months
Title
Sleep quality
Description
Sleep quality assessed using the Pittsburgh Sleep Quality Index
Time Frame
6 and 12 months
Title
Hospital admissions
Description
Information about hospitalisations due to falls and fall-related injuries will be collected by means of electronic linkage to the Norwegian Patient Registry and medical journals with the use of a unique 11-digit Norwegian national identification number for each participant.
Time Frame
12 months
Title
Use of primary health care, community care, and assistive technology
Description
Use of primary health care (general practitioner, emergency room, physiotherapist, and chiropractor), community care, and assistive technology during the study will be collected by linkage to the Norwegian Municipal Patient and User Register (KPR) database with the use of a unique 11-digit Norwegian national identification number for each participant.
Time Frame
12 months
Title
Use of prescription drugs
Description
Use of prescription drugs during the study will be collected by linkage to the Norwegian Prescribed Drug Registry with the use of a unique 11-digit Norwegian national identification number for each participant.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Musculoskeletal pain
Description
Musculoskeletal pain assessed using the "yes" or "no" question, "during the last year have you had pain in your muscles and/or joints that lasted for at least 3 consecutive months?". When answering "yes", participants will be asked to indicate the affected body areas. In addition, we will assess pain intensity for lower back and neck, specifically, using a 10-cm visual analogue scale (VAS).
Time Frame
6 and 12 months
Title
Changes in cardiac structure and function
Description
Echocardiographic indices of atrial and ventricular structure and function
Time Frame
12 months
Title
Mortality
Description
During the study unreported mortality will be assessed twice per year by linkage to the Norwegian population registry with the use of a unique 11-digit Norwegian national identification number for each participant.
Time Frame
12 months
Title
Cognitive function
Description
Cognitive function assessed using Mini-Mental State Examination (MMSE)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 80 years or older Low muscular strength (grip strength: <34.8 kg for males and <18.8 kg for females or chair stand >15 seconds) Community-dwelling incl. independent senior housing Ambulatory without supervision or physical assistance from another person. Assistive devices such as canes/crutches/walkers allowed. Able to see and hear sufficiently to undertake assessments and partake in the planned exercise training. Exclusion Criteria: Pre-existing diagnosis of dementia Moderate or severe cognitive impairment (score <18 on the Mini-Mental State Examination) Living in institutional care Non-ambulatory or requiring person or wheelchair to assist when walking Degenerative neurological and neuromuscular disease/disorder significantly influencing gait and mobility (e.g. amyotrophic lateral sclerosis [ALS] and Parkinson's disease). Amputation (other than toes) Contraindications to resistance training Unstable fracture Inability to comply with study requirements Currently undertaking progressive resistance training
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Berg, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Øivind Rognmo, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Department of Circulation and Medical Imaging
City
Trondheim
ZIP/Postal Code
7491
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

Reducing Falls With Progressive Resistance Training for the Oldest Old Adults With Sarcopenia

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