Effects of an exercise programme on asymptomatic monoclonal gammopathies

Not Applicable

Completed

• Conditions: Premalignant plasma cell conditions: smouldering multiple myeloma and monoclonal gammopathy of undetermined significance; Cancer

• Registration Number: ISRCTN65527208
• Lead Sponsor: niversity of Bath

Brief Summary

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38317104/ (added 06/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-14
• Study Completion: 2020-03-02
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Diagnostic criteria:
1.1. SMM. Defined by IMWG criteria as absence of MM defining events or amyloidosis, AND either: (i) serum monoclonal protein (IgG or IgA) >30 g/L OR urinary monoclonal protein >500 mg per 24 h, AND/OR (ii) clonal bone marrow plasma cells 10-60%. People with SMM, given their higher risk of progressing to MM, will initially be prioritised for enrollment into the trial, followed by people with MGUS, described next
OR
1.2. MGUS. Defined by IMWG criteria as absence of end-organ damage attributable to the plasma cell proliferative disorder (such as hypercalcaemia, renal insufficiency, anaemia, and bone lesions [CRAB]), or amyloidosis AND BMPC <10% AND serum M-protein <30 g/L
2. Age >18 years (adults and seniors)

Exclusion Criteria

1. World Health Organisation (WHO) performance status >1
2. Pregnancy
3. Deemed unsafe to exercise according to the Physical Activity Readiness Questionnaire
4. Any comorbidity that is likely to progress or be exacerbated over the course of the trial period
5. Cognitive impairment deemed a risk by the healthcare team for participation in the trial
6. Unable to understand explanations and/or provide informed consent
7. Any condition and/or behaviour that would pose undue personal risk or introduce bias into the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Uptake, measured at week 0 prior to trial period:<br>1.1. Recruitment rate - the proportion of patients approached who are screened<br>1.2. Screen-pass rate - the proportion of patients who attend screening that are deemed eligible<br>1.3. Randomisation rate - the proportion of patients that are randomised<br>2. Adherence: the proportion of prescribed sessions that are performed, measured in weeks 1-16 in the treatment arm only<br>3. Compliance: the exercise prescribed vs. exercise completed, measured at weeks 1-16 in the treatment arm only<br>4. Retention: the proportion of participants who complete both baseline and follow-up measures, measured in week 17<br>5. Safety: the incidence and severity of adverse events, measured at weeks 0-17

Secondary Outcome Measures

Name	Time	Method
1. Disease activity of SMM and MGUS, measured in week 0 and week 17<br>2. Physical fitness, measured by cardiopulmonary exercise test in week 0 and week 17<br>3. Physical activity level, measured by armband activity monitor in week 0 and week 16<br>4. Body composition, measured by dual-energy x-ray absorptiometry in week 0 and week 17<br>5. Quality of life, measured by questionnaires (quality of life, sleep, fatigue, frailty) in week 0 and week 17<br>6. Resting heart rate and blood pressure, measured in week 0 and week 17<br>7. CRAB indices (calcium, renal function, anaemia, bone health), measured in week 0 and week 17<br>8. Mechanistic measures (immune, inflammatory and metabolic biomarkers), measured in blood, saliva and urine sampled in week 0 and week 17