A Feasibility Study of Training in a Local Community Aimed Upon Health Promotion With Special Emphasis on Musculoskeletal Health Effects
Phase: NA
Conditions: Age-Related Osteoporosis
Sponsor: University of Copenhagen

A Feasibility Study of Training in a Local Community Aimed Upon Health Promotion 
with Special Emphasis on Musculoskeletal Health Effects  
 
 
 
3rd December 2021 
 
 
 
 
 
 
 
 
Study protocol with SAP 
 
 

A Feasibility Study of Training in a Local Community Aimed Upon Health Promotion 
with Special Emphasis on Musculoskeletal Health Effects  
 
 
 
The supervised multimodal training in the present 19-weeks study was offered to 
postmenopausal healthy women in a local community. The outcomes for the training group 
(MMT) were compared with a sedentary control group (CON). Training was offered twice 
weekly for one hour, and the average attendance rate of MMT participants over the 19wk had 
to be > 1 hour weekly.  
To collect baseline (BASE) data, all participants showed up in the laboratory at three occasions 
prior to the intervention. On the first visit, resting blood samples were collected to evaluate 
the concentration of bone turnover markers (BTM), and body weight, height, body 
composition, bone mineral density (BMD) and bone mass were measured. On the second visit, 
a dynamic balance test (four square step test) and a functional muscle strength and power test 
(jump-and-reach test) were performed. On the third visit, the aerobic capacity was evaluated 
by assessment of VO2-max. After three weeks (3wk) of training, resting blood samples were 
collected again. After 19wk of training, all assessments were repeated and compared with 
baseline, and MMT and CON were finally compared.  
Blood sample collection, DXA-scanning, and VO2-max tests were carried out at the Department 
of Nutrition, Exercise and Sports, University of Copenhagen, Denmark. The training and testing 
of vertical jump height, as well as dynamic balance, were performed at the health promotion 
training initiative in the Copenhagen area, Denmark. The blood samples were analyzed at the 
Department of Clinical Biochemistry, Rigshospitalet, Glostrup Hospital, Denmark. 
 
Participants  
Healthy, sedentary postmenopausal women aged below 70 years were eligible to participate 
in the present study. Inclusion criteria were: non-smoking and body mass index (BMI) <30 
kg/m2. Exclusion criteria were: T-score < -3 SD in the lumbar spine or hip; Z-score > 1.5 SD); use 
of hormone therapy, medical treatment, or supplements that affect bone metabolism; 
previous or current medical condition affecting bone health; engagement in regular and 
systemic weight-bearing training or strength training during the preceding two years. 
A flow diagram is shown below: Initially, twenty women were recruited to the training via an 
online advertisement and a local newspaper, but only 19 showed up for pre-testing. After a 
medical examination, one participant was excluded due to low BMD (T-score < -3 SD), and two 
were excluded due to high BMI (≥30 kg/m2). In addition, one woman refrained from 
participating in the training, and thus, 15 participants were recruited to MMT. During the study, 
two participants in MMT dropped out due to personal reasons and at the end of the study four 
participants were excluded in the analyses as their average attendance to the program was less 
than one hour per week. CON consisted of 13 age-matched sedentary postmenopausal women 
(12 from a previous study plus the woman who refrained from participating in the training), 
and therefore 9 MMT and 13 CON was finally included in the data analyses.  
 

A Feasibility Study of Training in a Local Community Aimed Upon Health Promotion 
with Special Emphasis on Musculoskeletal Health Effects  
 
 
 
 
CONSORT Flow Diagram 
 
 
Participants' baseline characteristics, including maximum oxygen consumption (VO2-max), are 
shown in Table 1. 
Table 1. Baseline characteristics of the participants 
MMT (n=9) 
   CON (n=13) 
p-value 
Age (years) 
    62.4 ± 3.8 
    58.7 ± 4.7 
0.061 
Height (cm) 
  166.9 ± 6.4 
  166.9 ± 5.2 
0.989 
Weight (kg) 
    72.8 ± 5.6 
    64.2 ± 10 
0.022* 
BMI (kg/m2) 
    26.3 ± 2.2 
    22.9 ± 2.9 
0.009* 
Body Fat Percentage (%) 
    39.4 ± 3.1 
    33.7 ± 8.5 
0.070 
Total Fat Mass (kg) 
    28.7 ± 2.7 
    22.2 ± 8.6 
0.043* 
Total Lean Body Mass (kg) 
    41.8 ± 4.3 
    39.8 ± 3.4 
0.233 
VAT-mass (g) 
     793 ± 351.2 
     511 ± 434.8 
0.123 

A Feasibility Study of Training in a Local Community Aimed Upon Health Promotion 
with Special Emphasis on Musculoskeletal Health Effects  
 
 
 
VAT-volume (cm3) 
  840.6 ± 372.2 
  541.7 ± 460.9 
0.123 
Total BMC (g) 
2266.9 ± 206.5 
2067.2 ± 300.2 
0.100 
BMD (g/cm2) 
 
 
 
   Whole-body 
1.121 ± 0.073 
1.046 ± 0.099 
0.066 
   Lumbar spine 
1.088 ± 0.137 
1.014 ± 0.111 
0.175 
   Right Femur neck 
0.918 ± 0.092 
0.834 ± 0.097 
0.057 
   Left Femur neck  
0.941 ± 0.088 
0.823 ± 0.076 
0.003* 
   Mean Femur neck 
0.929 ± 0.089 
0.829 ± 0.085 
0.015* 
   Right Total Femur 
0.947 ± 0.098 
0.864 ± 0.091 
0.056 
   Left Total Femur  
0.949 ± 0.101 
0.840 ± 0.091 
0.016* 
   Mean Total Femur  
0.948 ± 0.098 
0.852 ± 0.090 
0.028* 
   Right Trochanter 
0.741 ± 0.087 
0.683 ± 0.092 
0.149 
   Left Trochanter 
0.745 ± 0.091 
0.661 ± 0.097 
0.055 
   Mean Trochanter 
0.743 ± 0.086 
0.672 ± 0.093 
0.084 
   Right Shaft 
1.151 ± 0.126 
1.046 ± 0.125 
0.068 
   Left Shaft 
1.149 ± 0.131 
1.008 ± 0.121 
0.017* 
   Mean Shaft 
1.150 ± 0.126 
1.027 ± 0.121 
0.033* 
BTM 
 
 
 
   P1NP (µg/l) 
  52.8 ± 16.6 
  62.1 ± 21.3 
0.298 
   OC (µg/l) 
     19 ± 6.5 
  28.9 ± 7.1 
0.003* 
   CTX (ng/l) 
331.2 ± 100.7 
627.8 ± 253.8 
0.001* 
VO2-max (ml/min/kg) 
  28.2 ± 3.6 
  30.5 ± 4.7 
0.204 
Values are given as means ± SD. BMI = body mass index, BMD = bone mineral density, BTM = bone turnover 
marker. *Significant difference between groups (p<0.05). Unpaired T-test. 
 
Every participant was fully informed before giving her written informed consent to the 
procedures and potential discomfort associated with the study. The study was conducted in 
accordance with the Declaration of Helsinki and approved by the local ethics committee of the 
Capital Region of Denmark, H-18044190. 
 
 
Training program 
The present feasibility study evaluated the osteogenic impact of a training concept already 
offered by the health promotion initiative in a local community. 
According to the initiative, the training was offered as “evidence-based bone training” aimed 
upon enhancing musculoskeletal health. It was carried out twice a week, 60 minutes each 
session. The training concept included: 1) High- and odd-impact exercise including multi-
directional games; 2) Progressive resistance training; 3) Balance and coordination training. The 
participants were engaged in intermittent gymnastics and small game sessions aimed at 
imposing osteogenic and diverse strain on the skeleton, mainly in the legs and arms. Thus, the 
training included various jumping exercises (e.g., counter-movement jump, from the floor to 
the bench, and from one bench to the floor), quick walking up and down on gymnastics 

A Feasibility Study of Training in a Local Community Aimed Upon Health Promotion 
with Special Emphasis on Musculoskeletal Health Effects  
 
 
 
equipment, sprinting over short distances in different directions (in small games form). In 
addition, resistance exercises with power band and elastic bands, heavy exercise balls 
(medicine balls), and sandbags of 5-7 kg were applied. The training was performed intermittent 
and varied to ensure that the bones would not be desensitized, as it is seen in endurance 
training. 
 
BMD and body composition 
To test the BMD exclusion criteria at baseline as well as evaluate bone adaptation after 19wk 
of training, BMD (g/cm2) of proximal femur (PF), lumbar spine (LS), and whole-body (WB) were 
assessed by Dual-energy X-ray Absorptiometry scanning (iDXA, Lunar Corporation, Madison, 
Wisconsin, USA) according to standard procedures. The regions of interest were determined 
by the encore software (encore software version 14.10.022, GE Medical Systems, Madison, 
United States). In addition, body composition was evaluated by the whole-body scan: body 
weight (BW, kg), BMI (kg/m2), body fat percentage (%BF, %), total fat mass (FM, g), total lean 
body mass (LBM, g), visceral adipose tissue (VAT) mass (g) and volume (m3), and total bone 
mineral content (BMC, g). The participants were asked to remove metal objects and empty 
their bladder prior to scanning. 
 
Blood sampling & Biochemical analyses 
The plasma concentration of BTM at BASE, after 3wk, and after 19wk of training were 
measured. After an overnight fast and without any vigorous activities in the previous 48 hours, 
participants showed up in the laboratory in the early morning. Blood samples were collected 
from the antecubital vein with a butterfly needle, then transferred to EDTA tubes and 
centrifuged immediately. The plasma fractions were put on dry ice. Eighteen ml of blood were 
taken from each participant per test day. Following each test, a sample was placed at -80◦C for 
future P1NP, OC, and CTX analysis, which were assessed by the Chemiluminescence method 
using a fully automated immunoassay system (iSYS, Immunodiagnostic Systems Ltd., Bolton, 
England). The assay performance expressed as inter-run variation coefficients were 8% for 
P1NP, 9% for OC, and 10% for CTX. 
 
Training status 
To estimate the participants’ general training status, a progressive test of maximal oxygen 
uptake (VO2-max) (ml/kg/min) was performed on an electronic ergometer cycle (Monark 839E, 
Monark Exercise AB, Vansbro, Sweden) according to standard procedures. A breath-by-breath 
gas online analyzing system (Jaeger Oxycon Pro, VIASYS Healthcare, Höchberg, Germany) was 
connected to the participant, and a direct VO2-max measurement was conducted.  
 

A Feasibility Study of Training in a Local Community Aimed Upon Health Promotion 
with Special Emphasis on Musculoskeletal Health Effects  
 
 
 
Dynamic balance 
The “four square step test” (FSST) was performed to evaluate the dynamic balance [18] in 
MMT. The test requires a person to move systematically forward, sideward, backward, and 
sideward again over four narrow sticks circa 2.5 cm in diameter and 100 cm in length placed 
on the floor like a cross. The participants were requested to complete the sequence as fast as 
possible without touching the sticks. The participants started by facing the cross in the lower 
left quadrant, stepped forward over the stick into the next left quadrant, stepped sideward 
over the stick again into the upper right quadrant, and stepped backward over the stick into 
the lower right quadrant, then stepped sideward over the stick into the left quadrant where 
they started. Thus, they were moving in a clockwise direction. The floor in each square must 
be contacted by both feet, and the participants were asked to face forward for the whole 
sequence if possible. The participants were allowed to turn to step into the next square if 
needed. They started and finished in the same square, and the score were given in seconds 
(sec). The test was done twice, and the fastest time was used as the FSST score. 
 
Functional muscle strength and power  
The functional muscle strength and power were evaluated in MMT by a jump-and-reach test 
(vertical jump height) (Vertec Sports Imports, Hilliard, OH). First, the participants were taught 
how to perform a countermovement jump and how to displace the vanes that was placed 
above reaching height on a vertical stand. After thoroughly instruction and familiarization, the 
jump-and-reach test was performed. The maximum vertical jump height (cm) was determined 
by the difference between the participant standing reach height and the highest displaced 
vane. The greatest value out of three trials was taken as the result. 
 
Statistical analysis  
All of the statistical analyses were conducted using the Statistical Package for the Social 
Sciences (SPSS, version 26.0, IBM Corp., Armonk, NY, USA). The standard descriptive statistics 
and unpaired T-test were used to describe and test the baseline characteristics of the 
participants. Repeated measurements ANOVA and general linear model with post hoc tests 
were used to test the effect of training on BTM, BMD, dynamic balance, and the jump-and-
reach test. A p-value < 0.05 was considered significant.