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NCT Number: NCT07756762

Feasibility of Pre-Conditioning FRT in Sarcopenia

This study aims to assess whether a short, structured exercise programme is suitable and acceptable for older adults with early-stage muscle weakness (known as probable sarcopenia). Sarcopenia is a common condition associated with ageing that leads to reduced muscle strength, mobility, and independence, increasing the risk of falls, hospitalisation, and reduced quality of life.

Exercise, particularly resistance training, is recommended as the first-line treatment for sarcopenia. However, many programmes require participants to begin at relatively high levels of intensity, which may be challenging for individuals with low baseline strength or confidence. A short "pre-conditioning" phase of exercise may help prepare individuals physically and improve their ability to safely engage in more structured training in the future.

This study will investigate an 8-week functional resistance training (FRT) programme designed to improve movement ability, strength, and confidence using exercises that mimic everyday activities such as standing, stepping, and lifting. Participants will be randomly assigned to complete the same programme either in a supervised and clinic-based setting or independently and home-based setting following instruction and guidance.

The main aim of the study is to determine whether this type of programme is feasible and acceptable, including whether participants are willing to take part, attend sessions, and complete the programme safely. The study will also explore whether the programme may lead to improvements in physical function, strength, and quality of life.

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Key information

Conditions

Sarcopenia in Elderly Atrophy Behavior Motor Activity Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥65 years
  • Confirmed at screening with probable sarcopenia according to EWGSOP2 criteria, defined as low muscle strength.
  • Community-dwelling,
  • Able to consent,
  • Able to demonstrate safe functional resistance training exercise technique assessed during pre-randomisation familiarisation session.

Exclusion criteria

  • Diagnosed with Sarcopenia or severe sarcopenia (EWGSOP2)
  • Previous history of myocardial infarction within 12 months
  • Terminal illness,
  • Unstable cardiovascular disease
  • Uncontrolled hypertension
  • Cognitive impairment affecting consent
  • Recent major surgery
  • Pre-planned surgery in the next 12 months

Treatment and study plan

Pre-Conditioning Functional Resistance Exercise Program

Other

The intervention will consist of an 8-week pre-conditioning functional resistance training (FRT) programme, delivered twice weekly (30-60-minute sessions). Participants will be allocated to one of two groups: a supervised clinic-based exercise group or a home-based exercise group.

The programme will focus on multi-joint, task-oriented movements designed to replicate activities of daily living and improve functional capacity. Exercise intensity and volume will be prescribed using an autoregulated approach based on Borg CR Scale ® (Borg CR10) Rating of Perceived Exertion (RPE), allowing participants to adjust training in response to daily fatigue and readiness.

Clinic-based sessions will be supervised and progressed by the Chief Investigator, while home-based participants will perform the same prescribed exercises independently following initial instruction, with ongoing support and monitoring provided throughout the intervention period.

Primary outcomes

  1. Recruitment rate, eligibility rate, randomisation acceptability, adherence, retention rate and acceptability

    Time frame: From enrolment to the end of treatment at 8 weeks

    Recruitment rate, eligibility rate, randomisation acceptability, adherence, retention rate and acceptability of the exercise programme completed both in clinic, and at home.

Secondary outcomes

  1. Muscle mass via Bioelectrical Impedance Analysis

    Time frame: From enrolment until the end of the 8-week intervention period

  2. Grip Strength with Hand Dynomometer

    Time frame: From enrolment until the end of the 8-week intervention period

  3. Gait Speed over 4m

    Time frame: From enrolment until the end of the 8-week intervention period

    Reported in m/s.

  4. EQ-5D-5L

    Time frame: From enrolment until the end of the 8-week intervention period

    Quality of life questionnaire

  5. Short Physical Performance Battery

    Time frame: From enrolment until the end of the 8-week intervention period

    Scored in line with the European Working Group on Sarcopenia (EWGSOP2) criteria

Study contacts

Contact information is provided by the study sponsor or research team.

Alistair Lashley

CONTACT

[email protected]

+441482311824

Sponsors and collaborators

Lead sponsor

University of Hull

Other

Registry information

Official study title

A Feasibility Study of a Pre-Conditioning Functional Resistance Training Programme in Older Adults With Probable Sarcopenia

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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