NCT05691166

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Mar 2023Sep 2028

First Submitted

Initial submission to the registry

December 16, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2028

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

3.5 years

First QC Date

December 16, 2022

Last Update Submit

January 22, 2026

Conditions

SarcopeniaAging

Outcome Measures

Primary Outcomes (1)

  • Falls

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

    12 months

Secondary Outcomes (29)

  • Falls

    6 months

  • Falls

    6, 12, 24, and 36 months.

  • Falls requiring medical attention

    6, 12, 24, 36 months

  • Fall-related injuries

    6, 12, 24, 36 months

  • Dynamic muscular strength

    6 and 12 months

  • +24 more secondary outcomes

Other Outcomes (6)

  • Musculoskeletal pain

    6 and 12 months

  • Changes in cardiac structure and function

    12 months

  • Mortality

    0-12 and 0-36 months

  • +3 more other outcomes

Study Arms (2)

Progressive resistance training

EXPERIMENTAL

Twice weekly high-intensity progressive resistance training for 12 months

Behavioral: High-intensity progressive resistance training

Control

ACTIVE COMPARATOR

Participants randomised to the control group receive a booklet containing Norway's current recommendations for physical activity for older adults. These recommendations mean ≥150 minutes of moderate-intensity or ≥75 minutes of vigorous-intensity physical activity per week and two to three weekly balance and resistance training sessions. The booklet also includes pictures and instructions for seven exercises to help prevent falls.

Other: General practitioner care

Interventions

High-intensity progressive resistance trainingBEHAVIORAL

Supervised high-intensity progressive resistance training twice per week for 12 months

Progressive resistance training
General practitioner careOTHER

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.

Control

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 80 years or older
  • Low muscular strength (grip strength: \<41.3 kg for males and \<23.4 kg for females \[from 18.09.2024\] 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Circulation and Medical Imaging

Trondheim, 7491, Norway

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Jonathan Berg, PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Øivind Rognmo, PhD

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2022

First Posted

January 19, 2023

Study Start

March 30, 2023

Primary Completion (Estimated)

September 29, 2026

Study Completion (Estimated)

September 29, 2028

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

NO(1)