Feasibility of Pre-Conditioning FRT in Sarcopenia

NCT07756762 | Not Yet Recruiting

• 1 other identifier: RS261
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sarcopenia in Elderly

Keywords

Sarcopenia; Exercise; Pre-Conditioning; FRT; Functional Resistance Training

Outcome Measures

Primary Outcomes (1)

• Recruitment rate, eligibility rate, randomisation acceptability, adherence, retention rate and acceptability

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

  From enrolment to the end of treatment at 8 weeks

Secondary Outcomes (5)

• Muscle mass via Bioelectrical Impedance Analysis

  From enrolment until the end of the 8-week intervention period

• Grip Strength with Hand Dynomometer

  From enrolment until the end of the 8-week intervention period

• Gait Speed over 4m

  From enrolment until the end of the 8-week intervention period

• EQ-5D-5L

  From enrolment until the end of the 8-week intervention period

• Short Physical Performance Battery

  From enrolment until the end of the 8-week intervention period

Study Arms (2)

8-week clinic-based pre-conditioning functional resistance exercise programme

ACTIVE COMPARATOR

Other: Pre-Conditioning Functional Resistance Exercise Program

8-week home-based pre-conditioning functional resistance exercise programme

ACTIVE COMPARATOR

Other: Pre-Conditioning Functional Resistance Exercise Program

Interventions

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.

8-week clinic-based pre-conditioning functional resistance exercise programme; 8-week home-based pre-conditioning functional resistance exercise programme

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hull: lead

MeSH Terms

Conditions

Sarcopenia; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Central Study Contacts

Alistair Lashley

CONTACT

+441482311824; hyal35@hyms.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Endocrinology

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 11, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share