NCT05889598

Brief Summary

Osteoarthritis (degenerative joint disease) and osteoporosis (weak and fragile bones) are common conditions, particularly in women after menopause, and become even more common as we get older. Aging is also associated with sarcopenia, the progressive loss of muscle strength and mass with age. In this three-arm study, the effect of resistance exercise programs with different parameters (such as velocity and load) on various outcomes, including structural changes (bone mineral density, cartilage composition, muscle size), physical function, and biomarkers will be compared.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Mar 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Mar 2022Dec 2027

Study Start

First participant enrolled

March 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2022

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

4.8 years

First QC Date

April 26, 2022

Last Update Submit

April 16, 2026

Conditions

OsteoporosisOsteoarthritis

Keywords

ExerciseExplosive high-velocityBone mineral densityKnee jointNeuromuscularBiomarkers

Outcome Measures

Primary Outcomes (2)

  • Change in Femoral neck bone mineral content from baseline

    (g) measured by DXA

    32nd week

  • Change in Femoral neck bone mineral density from baseline

    (g/cm\^2) measured by DXA

    32nd week

Secondary Outcomes (40)

  • Bone Mineral Content (Femur)

    Baseline, 16th and 32nd weeks

  • Bone Mineral Density (Femur)

    Baseline, 16th and 32nd weeks

  • Bone Mineral Content (Spine)

    Baseline, 16th and 32nd weeks

  • Bone Mineral Density (Spine)

    Baseline, 16th and 32nd weeks

  • bone mineral content (Forearm)

    Baseline, 16th and 32nd weeks

  • +35 more secondary outcomes

Study Arms (3)

Ballistic resistance exercise training

EXPERIMENTAL

This arm will perform the exercises in a hack squat machine using low loads and explosive high-velocity (as if trying to jump)

Other: Ballistic Resistance Lower Body Strength Training

Conventional resistance exercise training

EXPERIMENTAL

This arm will perform the exercises in a hack squat machine using high-load and low-velocity (conventional training)

Other: Conventional Resistance Lower Body Strength Training

Control

NO INTERVENTION

Continue usual life

Interventions

Ballistic Resistance Lower Body Strength TrainingOTHER

The exercise programme involves two supervised sessions per week at University. Each session will involve 30-40 minutes of exercise, comprising warm-up , two main exercises: a hack squat and calf raise using a hack squat machine, and core exercises. After a warm-up period involving 5 minutes cycling and one set of 5 conventional repetitions at 40%1RM, the ballistic training group will complete eccentric phase hack squat exercise in approximately 3 seconds and the concentric phase as fast as possible with throwing type contractions. If participants can, participants will be allowed to take off in the concentric phase. To maintain high velocity in this group, lower loads will be used compared to the conventional group. The load will be decided according to regular maximal muscular strength test (1RM) to use of the correct weight for training (in proportion to the strength). Participants will start off using light weights and these will increase as participants become stronger.

Ballistic resistance exercise training
Conventional Resistance Lower Body Strength TrainingOTHER

The exercise programme involves two supervised sessions per week at Loughborough University. Each session will involve 30-40 minutes of exercise, comprising warm-up , two main exercises: a hack squat and calf raise using a hack squat machine, and core exercises. After a warm-up period involving 5 minutes cycling and one set of 5 conventional repetitions at 40% of 1RM, the conventional training group will complete eccentric and concentric phases of hack squatting exercises for approximately 3 seconds each, with appropriate breathing techniques. The load will be decided according to regular maximal muscular strength test (1RM) to use of the correct weight for training (in proportion to the strength). Participants will start off using light weights and these will increase as participants become stronger.

Conventional resistance exercise training

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women between 50-70 years;
  • Experienced last menstrual cycle, hormonal contraception or menopausal hormone replacement therapy at least five years ago;
  • Independent living and able to come into the university;
  • Healthy women: not previously diagnosed with osteoporosis or knee osteoarthritis, other major medical conditions;
  • Able to understand English.

You may not qualify if:

  • Any existing symptomatic knee, hip, back injury or any medical conditions or injuries which would affect the ability or safety to perform exercise or influence bone/cartilage, including unstable angina, uncontrolled hypertension, a history of heart failure, and a history of cardiovascular disease and conditions;
  • Taking medication affecting bone/cartilage metabolism;
  • Regular (\>once per week on average) participation in resistance training with loading greater than bodyweight or in high impact (impact greater than jogging);
  • Blood pressure exceeding 150/90 mmHg;
  • BMI \> 30 kg/m2;
  • Contraindications to MRI or DXA (e.g. Metallic implants);
  • Osteoporotic (FRAX score according to which the participant would be advised to seek treatment);
  • Fracture within the past year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Location

Related Publications (1)

  • Marques EA, Caliskan O, Brooke-Wavell K, Folland J. Feasibility of ballistic vs conventional resistance training in healthy postmenopausal women: A three-arm parallel randomised controlled trial. Maturitas. 2025 May;196:108246. doi: 10.1016/j.maturitas.2025.108246. Epub 2025 Mar 13.

    PMID: 40106971DERIVED

MeSH Terms

Conditions

OsteoporosisOsteoarthritisMotor Activity

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesArthritisJoint DiseasesRheumatic DiseasesBehavior

Study Officials

  • Katherine Brooke-Wavell, PhD

    Loughborough University

    PRINCIPAL INVESTIGATOR

  • Jonathan Folland, PhD

    Loughborough University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer in Human Biology

Study Record Dates

First Submitted

April 26, 2022

First Posted

June 5, 2023

Study Start

March 1, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

GB(1)