Sarcopenia in ElderlyNCT07756762
Feasibility of Pre-Conditioning FRT in Sarcopenia
A study testing Pre-Conditioning Functional Resistance Exercise Program in people with Sarcopenia in Elderly, run by University of Hull.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia in Elderly
- What is being tested?
- Pre-Conditioning Functional Resistance Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Feasibility Study of a Pre-Conditioning Functional Resistance Training Programme in Older Adults With Probable 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.
Read more
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
- Being tested
- Pre-Conditioning Functional Resistance Exercise Program
- Keywords
- Sarcopenia, Exercise, Pre-Conditioning, FRT, Functional Resistance Training
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Conditioning Functional Resistance Exercise ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 8-week clinic-based pre-conditioning functional resistance exercise programme | Active comparator | Not described Receives: Other: Pre-Conditioning Functional Resistance Exercise Program |
| 8-week home-based pre-conditioning functional resistance exercise programme | Active comparator | Not described Receives: Other: Pre-Conditioning Functional Resistance Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrolment to the end of treatment at 8 weeks
Secondary outcomes (5)
Muscle mass via Bioelectrical Impedance Analysis
Measured: From enrolment until the end of the 8-week intervention period
Grip Strength with Hand Dynomometer
Measured: From enrolment until the end of the 8-week intervention period
Gait Speed over 4m
Reported in m/s.
Measured: From enrolment until the end of the 8-week intervention period
EQ-5D-5L
Quality of life questionnaire
Measured: From enrolment until the end of the 8-week intervention period
Short Physical Performance Battery
Scored in line with the European Working Group on Sarcopenia (EWGSOP2) criteria
Measured: From enrolment until the end of the 8-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenia in ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hull
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thozhukat Sathyapalan, University of Hull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756762
- Sponsor's protocol ID
- RS261
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of a Pre-Conditioning Functional Resistance Training Programme in Older Adults With Probable Sarcopenia
- ClinicalTrials.gov ID
- NCT07756762
- Acronym / sponsor ID
- RS261
- Conditions
- Sarcopenia in Elderly
- Keywords
- Sarcopenia, Exercise, Pre-Conditioning, FRT, Functional Resistance Training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of HullUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Diagnosed with Sarcopenia or severe sarcopenia (EWGSOP2)
- Previous history of myocardial infarction within 12 months
- Terminal illness,
- Unstable cardiovascular disease
- Uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-Conditioning Functional Resistance Exercise ProgramThe 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. | Other | 8-week clinic-based pre-conditioning functional resistance exercise programme, 8-week home-based pre-conditioning functional resistance exercise programme |
Primary outcome
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.
5 secondary outcomes
Muscle mass via Bioelectrical Impedance Analysis
Time frame: From enrolment until the end of the 8-week intervention period
Grip Strength with Hand Dynomometer
Time frame: From enrolment until the end of the 8-week intervention period
Gait Speed over 4m
Time frame: From enrolment until the end of the 8-week intervention period
EQ-5D-5L
Time frame: From enrolment until the end of the 8-week intervention period
Short Physical Performance Battery
Time frame: From enrolment until the end of the 8-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-Conditioning Functional Resistance Exercise Program in people with Sarcopenia in Elderly, run by University of Hull.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alistair Lashley (+441482311824, hyal35@hyms.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate, eligibility rate, randomisation acceptability, adherence, retention rate and acceptability (time frame: From enrolment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.