Clinical trial NCT05691166: Reducing Falls With Progressive Resistance Training for the Oldest Old Adults With Sarcopenia
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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Sarcopenia
Aging
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 240
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Aged 80 years or older
* Low muscular strength (grip strength: \<39.6 kg for males and \<21.8 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

Primary outcomes:
measure: Falls
timeFrame: 12 months
Secondary outcomes:
measure: Falls
timeFrame: 6 months
measure: Falls
timeFrame: 6 and 12 months
measure: Falls requiring medical attention
timeFrame: 6 and 12 months
measure: Fall-related injuries
timeFrame: 6 and 12 months
measure: Dynamic muscular strength
timeFrame: 6 and 12 months
measure: Grip strength
timeFrame: 6 and 12 months
measure: Muscular power
timeFrame: 6 and 12 months
measure: Physical performance
timeFrame: 6 and 12 months
measure: Gait characteristics
timeFrame: 6 and 12 months
measure: Balance
timeFrame: 6 and 12 months
measure: Stature
timeFrame: 6 and 12 months
measure: Body mass
timeFrame: 6 and 12 months
measure: Body composition
timeFrame: 6 and 12 months
measure: Circumferences
timeFrame: 6 and 12 months
measure: Resting blood pressure and resting heart rate
timeFrame: 6 and 12 months
measure: Orthostatic blood pressure
timeFrame: 6 and 12 months
measure: Physical activity
timeFrame: 6 and 12 months
measure: Health-related quality of life
timeFrame: 6 and 12 months
measure: Fear of falling
timeFrame: 6 and 12 months
measure: Cognitive function
timeFrame: 6 and 12 months
measure: Depression
timeFrame: 6 and 12 months
measure: Frailty
timeFrame: 6 and 12 months
measure: Nutritional status
timeFrame: 6 and 12 months
measure: Sleep quality
timeFrame: 6 and 12 months
measure: Hospital admissions
timeFrame: 12 months
measure: Use of primary health care, community care, and assistive technology
timeFrame: 12 months
measure: Use of prescription drugs
timeFrame: 12 months
Other outcomes:
measure: Musculoskeletal pain
timeFrame: 6 and 12 months
measure: Changes in cardiac structure and function
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
measure: Cognitive function
timeFrame: 12 months
Locations:
city: Trondheim
country: Norway
facility: Department of Circulation and Medical Imaging
Study officials:
affiliation: Norwegian University of Science and Technology
name: Jonathan Berg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian University of Science and Technology
name: Øivind Rognmo, PhD
role: STUDY_DIRECTOR
References: